The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
295
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Time frame: From first dose to 2 years following last dose (up to 30 months)
Duration of Response (DOR)
DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Time frame: From first dose to 2 years following last dose (up to 30 months)
Progression Free Survival Rate (PFSR) at 24 Weeks
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (\>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (\<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
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Specified dose on specified days
City of Hope National Medical Center
Duarte, California, United States
University of Southern California (USC)
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Californa, Los Angeles (UCLA)
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
University of California San Diego
San Diego, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States
...and 40 more locations
Time frame: From first dose to 24 weeks after first dose
Percentage of Participants Experiencing Adverse Events (AEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
Time frame: From first dose to 100 days following last dose
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
Time frame: From first dose to 100 days following last dose
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
Time frame: From first dose to 100 days following last dose
Percentage of Participants Experiencing Death
This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
Time frame: From first dose to up to 45 months following first dose
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
The following measurements will be considered laboratory abnormalities for hepatic tests: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal
Time frame: From first dose to 100 days following last dose (approximately 9 months)
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
The following measurements will be considered laboratory abnormalities for thyroid tests: * TSH value \> ULN and * With baseline TSH value ≤ ULN * At least one T3/T4 test value \< LLN * Low TSH \< LLN and * With baseline TSH value ≥ LLN * At least one T3/T4 test value \> ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine
Time frame: From first dose to 100 days following last dose (approximately 9 months)