Trial Outcomes & Findings for S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00661193)

NCT ID: NCT00661193

Last Updated: 2020-02-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: From date of registration to 3 years or death, whichever comes first
• Results posted on: 2020-02-20

Participant Flow

Participant milestones

Measure	Erlotinib Hydrochloride Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Erlotinib Hydrochloride, Paclitaxel, Carboplatin Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	33	26
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	33	26

Reasons for withdrawal

Measure	Erlotinib Hydrochloride Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Erlotinib Hydrochloride, Paclitaxel, Carboplatin Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	3	1
Overall Study Progression	27	24
Overall Study Not protocol specified	1	0

Baseline Characteristics

S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Erlotinib Hydrochloride n=33 Participants Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Erlotinib Hydrochloride, Paclitaxel, Carboplatin n=26 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Total n=59 Participants Total of all reporting groups
Age, Continuous	74.9 years n=5 Participants	70.8 years n=7 Participants	72.4 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	19 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Histology Adenocarcinoma	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Histology Squamous	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Histology Large Cell	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Histology Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Smoking History Current	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Smoking History Former	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Smoking History Never	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Stage IIIB	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Stage IV	32 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants
Weight Loss Past 6 Months <5%	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Weight Loss Past 6 Months 5-<10%	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Weight Loss Past 6 Months 10-20%	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Weight Loss Past 6 Months >20%	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Weight Loss Past 6 Months Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of registration to 3 years or death, whichever comes first

Outcome measures

Measure	Erlotinib Hydrochloride n=33 Participants Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Erlotinib Hydrochloride, Paclitaxel, Carboplatin n=26 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months	1.6 months Interval 1.4 to 2.3	4.6 months Interval 3.0 to 6.7

SECONDARY outcome

Timeframe: From date of registration to 3 years or death, whichever comes first

Population: Although 33 patients were eligible for Erlotinib Hydrochloride, only 32 were evaluable for response due to one patient not having measurable disease at baseline.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:

Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Erlotinib Hydrochloride n=32 Participants Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Erlotinib Hydrochloride, Paclitaxel, Carboplatin n=26 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease	2 participants	6 participants

Adverse Events

Erlotinib Hydrochloride

Serious events: 10 serious events

Other events: 32 other events

Deaths: 0 deaths

Erlotinib Hydrochloride, Paclitaxel, Carboplatin

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Erlotinib Hydrochloride n=32 participants at risk Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Erlotinib Hydrochloride, Paclitaxel, Carboplatin n=26 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Cardiac General-Other	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Death not associated with CTCAE term - Death NOS	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Sudden death	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Infection-Other	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Carbon monoxide diffusion capacity (DL(co))	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Neutrophils/granulocytes (ANC/AGC)	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - Disease progression NOS	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Carbon monoxide diffusion capacity (DL(co))	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Vascular disorders Thrombosis/thrombus/embolism	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.

Other adverse events

Measure	Erlotinib Hydrochloride n=32 participants at risk Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Erlotinib Hydrochloride, Paclitaxel, Carboplatin n=26 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Blood and lymphatic system disorders Hemoglobin	34.4% 11/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	61.5% 16/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Cardiac disorders Pericardial effusion (non-malignant)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Cardiac disorders SVT and nodal arrhythmia - Sinus tachycardia	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Eye disorders Dry eye syndrome	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Eye disorders Keratitis (corneal inflammation/ulceration)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Eye disorders Ocular/Visual-Other	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Eye disorders Vision-blurred vision	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Constipation	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	38.5% 10/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Diarrhea	62.5% 20/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	76.9% 20/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Gastrointestinal-Other	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Heartburn/dyspepsia	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	18.8% 6/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	12.5% 4/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Nausea	34.4% 11/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	38.5% 10/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Pain - Abdomen NOS	12.5% 4/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Gastrointestinal disorders Vomiting	18.8% 6/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	34.6% 9/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Constitutional Symptoms-Other	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Edema: limb	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	30.8% 8/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Fatigue (asthenia, lethargy, malaise)	59.4% 19/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	69.2% 18/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Fever in absence of neutropenia, ANC lt1.0x10e9/L	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Pain - Chest/thorax NOS	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
General disorders Pain-Other	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	15.4% 4/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Immune system disorders Allergic reaction/hypersensitivity	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Lung	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Skin	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - UTI	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Infection with unknown ANC - Lung (pneumonia)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Infection with unknown ANC - Skin (cellulitis)	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Infection with unknown ANC - Urinary tract NOS	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Infections and infestations Infection-Other	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Injury, poisoning and procedural complications Bruising (in absence of Gr 3-4 thrombocytopenia)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	15.4% 4/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations AST, SGOT	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Alkaline phosphatase	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Bilirubin (hyperbilirubinemia)	21.9% 7/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	19.2% 5/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Creatinine	28.1% 9/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	19.2% 5/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations INR (of prothrombin time)	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Leukocytes (total WBC)	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	30.8% 8/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Lymphopenia	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Neutrophils/granulocytes (ANC/AGC)	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	30.8% 8/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Platelets	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	26.9% 7/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Investigations Weight loss	37.5% 12/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	31.2% 10/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	26.9% 7/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Anorexia	37.5% 12/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	30.8% 8/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Dehydration	12.5% 4/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	28.1% 9/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	26.9% 7/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	0.00% 0/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	31.2% 10/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	30.8% 8/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	19.2% 5/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Back	21.9% 7/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	19.2% 5/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Bone	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Chest wall	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	12.5% 4/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Joint	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	15.4% 4/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Musculoskeletal and connective tissue disorders Pain - Muscle	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	15.4% 4/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Nervous system disorders Dizziness	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	26.9% 7/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Nervous system disorders Neuropathy: sensory	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	38.5% 10/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Nervous system disorders Ocular/Visual-Other	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Nervous system disorders Pain - Head/headache	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Nervous system disorders Taste alteration (dysgeusia)	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	26.9% 7/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Nervous system disorders Tremor	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Psychiatric disorders Confusion	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Psychiatric disorders Insomnia	12.5% 4/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Psychiatric disorders Mood alteration - anxiety	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	11.5% 3/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Psychiatric disorders Mood alteration - depression	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Renal and urinary disorders Glomerular filtration rate	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Renal and urinary disorders Incontinence, urinary	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Renal and urinary disorders Pain - Bladder	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Renal and urinary disorders Renal failure	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Cough	31.2% 10/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	38.5% 10/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	40.6% 13/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	46.2% 12/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Hemorrhage, Respiratory tract NOS	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Dermatology/Skin-Other	12.5% 4/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	15.4% 4/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Dry skin	34.4% 11/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	21.9% 7/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	53.8% 14/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Induration/fibrosis (skin and subcutaneous tissue)	0.00% 0/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Nail changes	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Pruritus/itching	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Rash/desquamation	12.5% 4/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	65.6% 21/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	57.7% 15/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Skin and subcutaneous tissue disorders Rash: erythema multiforme	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Vascular disorders Hemorrhage/Bleeding-Other	6.2% 2/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	3.8% 1/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Vascular disorders Hypertension	3.1% 1/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	7.7% 2/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Vascular disorders Hypotension	15.6% 5/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	23.1% 6/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.
Vascular disorders Thrombosis/thrombus/embolism	9.4% 3/32 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.	15.4% 4/26 • From date of registration to 3 years or death, whichever comes first. All SAEs and AEs.

Additional Information

Lung Committee Statistician

SWOG Statistical Center

Phone: 206-667-6197

Email: jmoon@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place