This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Administered orally daily, 100 mg
Specified dose on specified days
Platinum-based doublet chemotherapy
Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group
Time frame: 24 months
Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first
Time frame: 34 months
Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause
Time frame: Approximately 5 years
Number of treatment-related adverse events (AE)
Time frame: Approximately 5 years
Number of treatment-related serious adverse events
Time frame: Approximately 5 years
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