The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves progression free survival (PFS) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
Name: Nivolumab
Name: Relatlimab
Name: Carboplatin
Name: Cisplatin
Name: Paclitaxel
Name: Nab-Paclitaxel
Name: Pemetrexed
Description: Part 1
Measure: Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose Time: Up to 10 months, from first participant's first doseDescription: Part 2
Measure: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR) Time: 10 months after randomization, up to 21 monthsDescription: Part 1
Measure: Incidence of TRAEs leading to discontinuation Time: Up to 10 months, 30 days from participant's last doseDescription: Part 1
Measure: Incidence of Serious Adverse Events (SAEs) Time: Up to 10 months, 30 days from participant's last doseDescription: Part 1
Measure: Incidence of select Adverse Events (AEs) Time: Up to 10 months, 30 days from participant's last doseDescription: Part 2
Measure: PFS per RECIST v1.1 by BICR in biomarker subgroups Time: Until progression, up to 21 monthsDescription: Part 2
Measure: Overall response rate (ORR) per RECIST v1.1 by BICR Time: Up to 21 monthsDescription: Part 2
Measure: Incidence of Serious Adverse Events (SAEs) Time: Up to 21 monthsDescription: Part 2
Measure: Incidence of select Adverse Events (AEs) Time: Up to 21 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Inclusion Criteria: - Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization - Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria - No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease Exclusion Criteria: - Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy - Untreated CNS metastases - Leptomeningeal metastases (carcinomatous meningitis) - Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to enrollment (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before registration and the participant has no evidence of disease) - Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com --- V600E ---
Inclusion Criteria: - Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization - Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria - No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease Exclusion Criteria: - Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy - Untreated CNS metastases - Leptomeningeal metastases (carcinomatous meningitis) - Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to enrollment (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before registration and the participant has no evidence of disease) - Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply Non-small Cell Lunch Cancer Recurrent Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- V600E ---