The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease
Name: Ipilimumab
Description: Specified dose on specified dayType: BiologicalModule A
Name: Nivolumab
Description: Specified dose on specified dayType: BiologicalModule A
Name: Carboplatin
Description: Specified dose on specified dayType: DrugModule A Module B
Name: Paclitaxel
Description: Specified dose on specified dayType: DrugModule A Module B
Name: Pemetrexed
Description: Specified dose on specified dayType: DrugModule A Module B
Name: Cisplatin
Description: Specified dose on specified dayType: DrugModule A Module B
Description: To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy
Measure: Overall Survival (OS) Time: Up to 31 monthsDescription: To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
Measure: Progression Free Survival (PFS) Time: Up to 31 monthsDescription: To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
Measure: Overall Response Rate (ORR) Time: Up to 31 monthsDescription: In participants with different PD-L1 levels
Measure: ORR Time: Up to 31 monthsDescription: In participants with different PD-L1 levels
Measure: PFS Time: Up to 31 monthsDescription: In participants with different PD-L1 levels
Measure: OS Time: Up to 31 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Inclusion Criteria: - Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 - Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria - Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period Exclusion Criteria: - Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded - Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded - Participants with untreated CNS metastases are excluded. --- L858R ---