CompletedPhase 3NCT03215706

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

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

Checked against the public recordLast updated Dec 17, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations116
SponsorBristol-Myers Squibb
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Interventions being studied
Biological: Ipilimumab; Biological: Nivolumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment Other protocol inclusion/exclusion criteria may apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Health SystemsColorado Springs, Colorado
  • Local Institution - 0044Plainville, Connecticut
  • Local Institution - 0045Jacksonville, Florida
  • Local Institution - 0029Marietta, Georgia
  • Local Institution - 0091Wichita, Kansas
  • Local Institution - 0004Lexington, Kentucky
  • Local Institution - 0105Detroit, Michigan
  • Local Institution - 0058Johnson City, New York
  • Local Institution - 0098Mineola, New York
  • Local Institution - 0095Columbus, Ohio
  • Local Institution - 0006Lancaster, Pennsylvania
  • Local Institution - 0047Pittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 17, 2025. Always confirm current availability with the study team.

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