The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
367
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)
PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment. Based on Kaplan-Meier estimates
Time frame: From randomization to the date of first documented tumor progression or death (approximately 58 months)
Overall Survival (OS)
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive. Median based on Kaplan-Meier Estimates
Time frame: From randomization to the date of death due to any cause (up to approximately 67 months)
Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)
ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment. BOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. CR+PR, confidence interval based on the Clopper and Pearson method.
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Specified dose on specified days
Specified dose on specified days
Pacific Shores Medical Group
Long Beach, California, United States
Local Institution - 0029
Los Angeles, California, United States
Local Institution - 0033
Los Angeles, California, United States
Local Institution - 0061
Orange, California, United States
Torrance Memorial Physican Network
Redondo Beach, California, United States
Local Institution - 0003
New Haven, Connecticut, United States
Local Institution - 0004
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Local Institution - 0002
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 99 more locations
Time frame: From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)
DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first. PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to \<10 mm (whether target or non-target). Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy. Participants who neither progress nor die were censored on the date of their last assessment. Median computed using Kaplan-Meier method
Time frame: From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)
9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.
Time frame: 9 months after first treatment dose
12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.
Time frame: 12 Months after first treatment dose