The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Time frame: Up to 5 years
OS in randomized participants with PD-L1 ≥ 1%
Time frame: Up to 5 years
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Time frame: Up to 5 years
Overall response rate (ORR)
Time frame: Up to 5 years
Duration of response (DoR)
Time frame: Up to 5 years
Number of participants with adverse events (AEs)
Time frame: Up to 2.5 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 2.5 years
Number of participants with immune-mediated adverse events (IMAEs)
Time frame: Up to 2.5 years
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score
Time frame: Up to 2 years
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0487
Mobile, Alabama, United States
NOT_YET_RECRUITINGSouthern Arizona VA Health Care System
Tucson, Arizona, United States
RECRUITINGLocal Institution - 0112
Los Angeles, California, United States
WITHDRAWNUniversity of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
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San Francisco, California, United States
COMPLETEDUCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
RECRUITINGLocal Institution - 0500
Grand Junction, Colorado, United States
NOT_YET_RECRUITINGLocal Institution - 0472
Westminster, Colorado, United States
NOT_YET_RECRUITINGLocal Institution - 0206
Miami, Florida, United States
COMPLETEDMemorial Hospital West
Pembroke Pines, Florida, United States
RECRUITING...and 317 more locations