Trial Outcomes & Findings for SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma (NCT NCT01362790)

Last Updated: 2019-06-06

Results Overview

Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

55 participants

Primary outcome timeframe

52 months and 4 days

Results posted on

2019-06-06

Participant Flow

55 participants were enrolled. No data was collected for 10/55 participants who were screened for neutralizing antibodies and were positive, thus not enrolled into a Group /Arm, nor treated. 45/55 participants were treated on this study.

Participant milestones

Participant milestones
Measure	Mesothelioma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen B Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles. During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Pilot Phase & Phase 2 STARTED	11	8	7	15	0	4
Pilot Phase & Phase 2 COMPLETED	1	0	2	1	0	0
Pilot Phase & Phase 2 NOT COMPLETED	10	8	5	14	0	4
Dose De-escalation of Regimen A STARTED	0	0	0	0	8	0
Dose De-escalation of Regimen A COMPLETED	0	0	0	0	2	0
Dose De-escalation of Regimen A NOT COMPLETED	0	0	0	0	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Mesothelioma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen B Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles. During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Pilot Phase & Phase 2 Changed treatment, too early to assess	1	0	0	0	0	0
Pilot Phase & Phase 2 Adverse Event	0	1	0	1	0	2
Pilot Phase & Phase 2 Physician Decision	0	0	0	1	0	0
Pilot Phase & Phase 2 Developed antibodies	7	2	3	8	0	0
Pilot Phase & Phase 2 Refused further treatment	0	1	0	0	0	0
Pilot Phase & Phase 2 Progressive disease	1	2	2	3	0	2
Pilot Phase & Phase 2 Treatment delay >3 weeks	1	0	0	0	0	0
Pilot Phase & Phase 2 Complicating disease/intercurr. illness	0	2	0	0	0	0
Pilot Phase & Phase 2 Death on study	0	0	0	1	0	0
Dose De-escalation of Regimen A Adverse Event	0	0	0	0	1	0
Dose De-escalation of Regimen A Deveoped antibodies	0	0	0	0	3	0
Dose De-escalation of Regimen A Progressive disease	0	0	0	0	2	0

Baseline Characteristics

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mesothelioma Pilot Phase Regimen A n=11 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen B n=8 Participants Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	33 Participants n=115 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	12 Participants n=115 Participants
Age, Continuous	55.27 years STANDARD_DEVIATION 7.68 • n=5 Participants	60.55 years STANDARD_DEVIATION 16.41 • n=7 Participants	49.91 years STANDARD_DEVIATION 16.32 • n=5 Participants	64.21 years STANDARD_DEVIATION 7.65 • n=4 Participants	52.53 years STANDARD_DEVIATION 6.77 • n=21 Participants	—	56.49 years STANDARD_DEVIATION 10.97 • n=115 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	—	14 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants	3 Participants n=21 Participants	—	31 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	—	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	4 Participants n=21 Participants	—	44 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	—	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	1 Participants n=115 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants	4 Participants n=21 Participants	—	42 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Region of Enrollment United States	11 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants	4 Participants n=21 Participants	—	45 Participants n=115 Participants
Count of Participants with a Peritoneum and Pleural Tumor Site Peritoneum	2 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	10 Participants n=115 Participants
Count of Participants with a Peritoneum and Pleural Tumor Site Pleural	9 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants	0 Participants n=21 Participants	—	31 Participants n=115 Participants
Count of Participants with a Peritoneum and Pleural Tumor Site Pancreatic	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	—	4 Participants n=115 Participants

PRIMARY outcome

Timeframe: 52 months and 4 days

Population: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=11 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen n=8 Participants Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Response Assessment Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Response Assessment Partial Response	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Response Assessment Stable Disease	5 Participants	6 Participants	6 Participants	6 Participants	1 Participants	—
Response Assessment Progressive Disease	3 Participants	1 Participants	1 Participants	3 Participants	2 Participants	—

PRIMARY outcome

Timeframe: On last day of last dosing cycle, end of cycle 1 (day 30)

Population: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Development of antibodies following treatment with SS1P. The goal was to delay development of antibodies to SS1P so a patient could get a second cycle of therapy with SS1P.

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=11 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen n=8 Participants Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Count of Participants With SS1P Antibody Formation	6 Participants	2 Participants	3 Participants	7 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 64 months and 26 days

Population: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=11 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen n=8 Participants Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide	11 Participants	8 Participants	7 Participants	15 Participants	4 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 1, 3, and 5 of a 21 day cycle

Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose.

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=8 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01	25 mcg/kg/dose	—	—	—	—	—

SECONDARY outcome

Timeframe: 36 months

Population: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis).

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=11 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen n=8 Participants Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Overall Survival	8.9 Months Interval 5.4 to 32.2	11.2 Months Interval 1.0 to 13.0	29.3 Months Interval 3.4 to 29.3	4.2 Months Interval 2.0 to 7.9	9.3 Months Interval 1.2 to 15.1	—

SECONDARY outcome

Timeframe: 36 months

Population: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=11 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen n=8 Participants Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Progression-free Survival	11.8 Months Interval 1.6 to 13.6	8.8 Months Interval 0.6 to 13.0	8.9 Months Interval 1.8 to Upper bound confidence interval is undefined because there are too few subjects and progressions after the median time to estimate the confidence bound; it cannot be calculated.	3.9 Months Interval 1.6 to 6.4	4.4 Months Interval 0.9 to 7.4	—

SECONDARY outcome

Timeframe: up to 2.5 years

Population: In months; the only 3 responders were in group one, thus arm/groups 2-7 are not shown here.

DOR is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is measured from the time measurement criteria is met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10mm. partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study).

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=3 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Duration of Response	16.3 Months Interval 10.6 to 26.2	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Cycles 1-6, up to 180 days

Population: No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Here are the number of participants who had SS1P cycles during cycle 1-6.

Outcome measures

Outcome measures
Measure	Mesothelioma Pilot Phase Regimen A n=11 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen n=8 Participants Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 Participants Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Count of Participants SS1P Cycles Received Following Onstudy SS1P 1 Cycle	1 Participants	3 Participants	0 Participants	5 Participants	2 Participants	0 Participants
Count of Participants SS1P Cycles Received Following Onstudy SS1P 2 Cycles	8 Participants	0 Participants	4 Participants	8 Participants	1 Participants	0 Participants
Count of Participants SS1P Cycles Received Following Onstudy SS1P 3 Cycles	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Count of Participants SS1P Cycles Received Following Onstudy SS1P 4 Cycles	1 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Count of Participants SS1P Cycles Received Following Onstudy SS1P 5 Cycles	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Count of Participants SS1P Cycles Received Following Onstudy SS1P 6 Cycles	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Mesothelioma Pilot Phase Regimen A

Serious events: 6 serious events

Other events: 11 other events

Deaths: 5 deaths

Mesothelioma Pilot Phase Regimen B

Serious events: 8 serious events

Other events: 8 other events

Deaths: 8 deaths

Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase

Serious events: 3 serious events

Other events: 7 other events

Deaths: 3 deaths

Phase 2 Pleural Mesothelioma Pilot Expansion Phase

Serious events: 9 serious events

Other events: 15 other events

Deaths: 9 deaths

Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mesothelioma Pilot Phase Regimen A n=11 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen B n=8 participants at risk Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A n=8 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Death NOS	45.5% 5/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	26.7% 4/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Fever	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Infections and infestations Lung infection	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	26.7% 4/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Atrial fibrillation	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Other adverse events

Other adverse events
Measure	Mesothelioma Pilot Phase Regimen A n=11 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Pilot Phase Regimen B n=8 participants at risk Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.	Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase n=7 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Pleural Mesothelioma Pilot Expansion Phase n=15 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A n=8 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.	Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A n=4 participants at risk Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.	Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
Investigations Activated partial thromboplastin time prolonged	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	46.7% 7/15 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Alanine aminotransferase increased	54.5% 6/11 • Number of events 17 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	46.7% 7/15 • Number of events 19 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Alkaline phosphatase increased	18.2% 2/11 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 13 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	42.9% 3/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Anal pain	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Blood and lymphatic system disorders Anemia	72.7% 8/11 • Number of events 31 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 44 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	57.1% 4/7 • Number of events 28 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	73.3% 11/15 • Number of events 39 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 8/8 • Number of events 35 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Anorexia	54.5% 6/11 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	42.9% 3/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Psychiatric disorders Anxiety	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Injury, poisoning and procedural complications Aspartate aminotransferase increased	63.6% 7/11 • Number of events 20 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 17 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	42.9% 3/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	46.7% 7/15 • Number of events 19 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	75.0% 6/8 • Number of events 16 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 9 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Asystole	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Atrial fibrillation	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Atrial flutter	18.2% 2/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Musculoskeletal and connective tissue disorders Back pain	36.4% 4/11 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Bloating	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Blood bilirubin increased	18.2% 2/11 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Eye disorders Blurred vision	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Vascular disorders Capillary leak syndrome	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Cardiac disorders - Other, (coronary artery disease)	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Musculoskeletal and connective tissue disorders Chest wall pain	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Chills	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Psychiatric disorders Confusion	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Eye disorders Conjunctivitis	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Constipation	72.7% 8/11 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	57.1% 4/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	40.0% 6/15 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 9 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Eye disorders Corneal ulcer	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	33.3% 5/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Creatinine increased	27.3% 3/11 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 14 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	46.7% 7/15 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Dehydration	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Psychiatric disorders Depression	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Dizziness	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	26.7% 4/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Dry mouth	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	57.1% 4/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 9 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Dysgeusia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Dysphagia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	42.9% 3/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	40.0% 6/15 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Ear and labyrinth disorders Ear pain	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Edema face	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Edema limbs	54.5% 6/11 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 9 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	42.9% 3/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	73.3% 11/15 • Number of events 29 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Ejection fraction decreased	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Encephalopathy	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Erythroderma	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Fatigue	63.6% 7/11 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	57.1% 4/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	60.0% 9/15 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Fever	9.1% 1/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	53.3% 8/15 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Eye disorders Flashing lights	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Flatulence	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Vascular disorders Flushing	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Vascular disorders Hot flashes	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	26.7% 4/15 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hyperglycemia	90.9% 10/11 • Number of events 35 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	75.0% 6/8 • Number of events 28 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	71.4% 5/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 15/15 • Number of events 71 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	75.0% 6/8 • Number of events 20 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hyperkalemia	27.3% 3/11 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	71.4% 5/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	46.7% 7/15 • Number of events 13 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypermagnesemia	45.5% 5/11 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Vascular disorders Hypertension	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 19 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	42.9% 3/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	40.0% 6/15 • Number of events 14 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 11/11 • Number of events 34 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 57 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	85.7% 6/7 • Number of events 38 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	80.0% 12/15 • Number of events 66 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 8/8 • Number of events 37 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 13 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypocalcemia	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	46.7% 7/15 • Number of events 17 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypoglycemia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypokalemia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypomagnesemia	45.5% 5/11 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 21 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	33.3% 5/15 • Number of events 13 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hyponatremia	72.7% 8/11 • Number of events 26 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 7/7 • Number of events 22 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	86.7% 13/15 • Number of events 45 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 8/8 • Number of events 28 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Metabolism and nutrition disorders Hypophosphatemia	18.2% 2/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 23 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	57.1% 4/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	60.0% 9/15 • Number of events 37 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 4/8 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Vascular disorders Hypotension	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	53.3% 8/15 • Number of events 13 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Endocrine disorders Hypothyroidism	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	33.3% 5/15 • Number of events 9 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Infections and infestations Infections and infestations - Other, (folliculitis on abdomen and back)	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Psychiatric disorders Insomnia	27.3% 3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	40.0% 6/15 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Lethargy	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Lymphocyte count decreased	100.0% 11/11 • Number of events 121 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 8/8 • Number of events 86 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 7/7 • Number of events 83 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 15/15 • Number of events 140 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 8/8 • Number of events 84 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	100.0% 4/4 • Number of events 22 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Mucositis oral	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, (muscle twitching)	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Myocardial infarction	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Nausea	72.7% 8/11 • Number of events 9 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	71.4% 5/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	86.7% 13/15 • Number of events 28 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Nervous system disorders - Other, (vocal cord paralysis)	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Neutrophil count decreased	18.2% 2/11 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	62.5% 5/8 • Number of events 16 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 9 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 13 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	45.5% 5/11 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
General disorders Pain	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	26.7% 4/15 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Paresthesia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Platelet count decreased	27.3% 3/11 • Number of events 11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 29 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	26.7% 4/15 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	50.0% 2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Eye disorders Photophobia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	33.3% 5/15 • Number of events 12 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	26.7% 4/15 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, (tachypnea)	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Psychiatric disorders Restlessness	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Sinus bradycardia	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	57.1% 4/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Sinus tachycardia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	33.3% 5/15 • Number of events 10 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Infections and infestations Skin infection	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Somnolence	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Vascular disorders Superior vena cava syndrome	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Supraventricular tachycardia	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Vascular disorders Thromboembolic event	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Toothache	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Tremor	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	20.0% 3/15 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Infections and infestations Upper respiratory infection	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Renal and urinary disorders Urinary frequency	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Renal and urinary disorders Urinary incontinence	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Renal and urinary disorders Urinary retention	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Infections and infestations Urinary tract infection	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Nervous system disorders Vasovagal reaction	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Cardiac disorders Ventricular arrhythmia	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Gastrointestinal disorders Vomiting	27.3% 3/11 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	57.1% 4/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	40.0% 6/15 • Number of events 16 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Weight gain	36.4% 4/11 • Number of events 6 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	37.5% 3/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	53.3% 8/15 • Number of events 25 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Weight loss	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	28.6% 2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	13.3% 2/15 • Number of events 7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 2/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Respiratory, thoracic and mediastinal disorders Wheezing	18.2% 2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	6.7% 1/15 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations White blood cell decreased	72.7% 8/11 • Number of events 33 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 70 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	71.4% 5/7 • Number of events 25 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	73.3% 11/15 • Number of events 55 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	87.5% 7/8 • Number of events 36 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	75.0% 3/4 • Number of events 19 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Infections and infestations Infections and infestations - Other, (tinea corporis on nape of neck)	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/4 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Investigations Lipase increased	0.00% 0/11 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/8 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	0.00% 0/15 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.	— 0/0 • Date treatment consent signed to date off study, approximately 64 months and 26 days. No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.

Additional Information

Dr. Raffit Hassan

National Cancer Institute

Phone: 301-451-8742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place