Trial Outcomes & Findings for Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations (NCT NCT02949843)

Last Updated: 2024-06-28

Results Overview

Objective Response is defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). This outcome applies only to Arm I. \* Complete Response (CR): Disappearance of all target lesions, \* Partial Response (PR): At least a 30% decrease in the sum of the target lesions Progressive Disease (PD): At least a 20% increase in the sum of the target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Up to 1 year after failure of targeted therapy

Results posted on

2024-06-28

Participant Flow

Nineteen patients were enrolled in the study from March 2017 to January 2018. Thirteen patients did not progress on the initial tyrosine kinase inhibitor treatment within one year. The data entered here relate to the six patients who did progress within one year.

Thirteen patients did not progress within one year after treatment with a tyrosine kinase inhibitor and did not continue on the study.

Participant milestones

Participant milestones
Measure	Arm I (Nivolumab, Pembrolizumab) Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Overall Study STARTED	1	2	3
Overall Study COMPLETED	1	1	2
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Nivolumab, Pembrolizumab) Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Overall Study Withdrawal by Subject	0	1	1

Baseline Characteristics

Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Nivolumab, Pembrolizumab) n=1 Participants Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) n=2 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) n=3 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO	Total n=6 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
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	61 years STANDARD_DEVIATION 0 • n=5 Participants	54.5 years STANDARD_DEVIATION 17.7 • n=7 Participants	63.7 years STANDARD_DEVIATION 3.5 • n=5 Participants	60.2 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Caucasian (White)	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · African American (Black)	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 1 year after failure of targeted therapy

Population: This outcome applies only to Arm I.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Pembrolizumab) n=1 Participants Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Objective Response Rate in Patients With High PD-L1 Expressing Cancers After Failure of Targeted Therapy Defined as Complete or Partial Response According to the Investigator's Assessment Partial Response	1 Participants	0 Participants	0 Participants
Objective Response Rate in Patients With High PD-L1 Expressing Cancers After Failure of Targeted Therapy Defined as Complete or Partial Response According to the Investigator's Assessment Stable Disease	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Adverse events were collected following each cycle of treatment (1-4) and up to 30 days after the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks.

Population: One patient in Arm II refused additional treatment and was not evaluated for adverse events, although this patient was followed for survival.

Toxicities for each group will be estimated and described using counts and frequencies by grade, location and relatedness.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Pembrolizumab) n=1 Participants Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) n=1 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) n=3 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Number of Participants With Adverse Events Measured Using Common Terminology Criteria for Adverse Events Version 4.0	1 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 1 year after failure of targeted therapy

Population: This outcome applies only to Arms II and III; secondary gene mutation testing was not done in Arm I.

This outcome applies to only Arms II and III.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Pembrolizumab) Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) n=2 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) n=3 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Number of Mutations in Secondary Genes for Patients With PD-L1 Expression < 50% T790M	—	0 Participants	2 Participants
Number of Mutations in Secondary Genes for Patients With PD-L1 Expression < 50% Alk G1202R plus ROS-1	—	0 Participants	1 Participants
Number of Mutations in Secondary Genes for Patients With PD-L1 Expression < 50% No secondary driver identified	—	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 3 years after failure of targeted therapy

Population: One patient in Arm II refused additional treatment and is not evaluable for response; one patient in Arm III expired one month after starting secondary treatment and is not evaluable for response.

Objective response rates will be estimated in the two PD-L1 expression \< 50% arms. At the time of protocol development, the intention was to estimate confidence intervals for each of these rates, and to make an exploratory comparison among the three groups comparing complete response/partial response versus stable disease/progressive disease among the groups using a Fisher's exact test (for the 2x3 table). Due to the low numbers of patients evaluable for response, these analyses were not performed.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Pembrolizumab) n=1 Participants Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) n=1 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) n=2 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Objective Response Rates for Patients Without High PD-L1 Expressing Cancers Partial Response	1 Participants	0 Participants	1 Participants
Objective Response Rates for Patients Without High PD-L1 Expressing Cancers Progressive Disease	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From date of progression on primary targeted treatment to death, assessed up to 3 years.

Population: Patient records were reviewed at this time for all six patients.

Estimated using Kaplan-Meier methods and survival rates will be compared using log-rank tests. Note: Log-rank tests will not be used due to the very low sample size.

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Pembrolizumab) n=1 Participants Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) n=2 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) n=3 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Overall Survival	36 months Interval 36.0 to 36.0	8.3 months Interval 0.72 to 15.94	2.56 months Interval 1.08 to 36.0

SECONDARY outcome

Timeframe: Assessed at enrollment into study.

Smoking History was defined as Never, Former or Current

Outcome measures

Outcome measures
Measure	Arm I (Nivolumab, Pembrolizumab) n=1 Participants Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) n=2 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) n=3 Participants Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Rate of Tobacco Use and Mutation Burden Based on PD-L1 Expression at Time of Progression Never Smoked	1 Participants	2 Participants	1 Participants
Rate of Tobacco Use and Mutation Burden Based on PD-L1 Expression at Time of Progression Formerly Smoked	0 Participants	0 Participants	2 Participants
Rate of Tobacco Use and Mutation Burden Based on PD-L1 Expression at Time of Progression Currently Smoke	0 Participants	0 Participants	0 Participants

Adverse Events

Arm I (Nivolumab, Pembrolizumab)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 2 deaths

Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Nivolumab, Pembrolizumab) n=1 participants at risk Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Pembrolizumab: Given IV	Arm II (Kinase Inhibitor, Chemotherapy, Immunotherapy) n=1 participants at risk Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Tyrosine Kinase Inhibitor: Given PO	Arm III (Kinase Inhibitor, Targeted Therapy, Other Treatment) n=3 participants at risk Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks. Chemotherapy: Receive other treatment Immunotherapy: Receive other treatment Laboratory Biomarker Analysis: Correlative studies Targeted Molecular Therapy: Receive drug targeting secondary mutation Tyrosine Kinase Inhibitor: Given PO
Investigations Creatinine increased	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	100.0% 1/1 • Number of events 1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	0.00% 0/3 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	100.0% 1/1 • Number of events 1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	0.00% 0/3 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.
Cardiac disorders Cardiac arrest	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	100.0% 1/1 • Number of events 1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	0.00% 0/3 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	66.7% 2/3 • Number of events 2 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	66.7% 2/3 • Number of events 2 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.
Infections and infestations Sepsis	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	33.3% 1/3 • Number of events 1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	0.00% 0/1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.	33.3% 1/3 • Number of events 1 • Adverse events were collected following each cycle of treatment (1-4), and up to 30 days following the last dose of study treatment. The average collection time from start of treatment was 7 weeks, with a range of 3 to 11 weeks. One patient refused additional treatment after the initial progression and was not followed for adverse events, but was followed for mortality.

Other adverse events

Additional Information

William Petty

Wake Forest Baptist Comprehensive Cancer Center

Phone: 3367163313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place