CompletedPhase 3NCT02477826

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Checked against the public recordLast updated Oct 30, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations290
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
Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Paclitaxel
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

Inclusion Criteria: * Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy * Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period * 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 Exclusion Criteria: * Subjects with untreated Central nervous system (CNS) metastases are excluded * Subjects with an active, known or suspected autoimmune disease are excluded * Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection Other protocol defined inclusion/exclusion criteria 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

  • Southern Cancer Center, Inc.Mobile, Alabama
  • Local Institution - 0017San Francisco, California
  • Local Institution - 0021New Haven, Connecticut
  • Local Institution - 0001Atlanta, Georgia
  • Local Institution - 0013Marietta, Georgia
  • Local Institution - 0004Lexington, Kentucky
  • Local Institution - 0115St Louis, Missouri
  • Local Institution - 0005Buffalo, New York
  • Local Institution - 0019New York, New York
  • Local Institution - 0014Cleveland, Ohio
  • Local Institution - 0009Columbus, Ohio
  • Local Institution - 0007Allentown, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 30, 2025. Always confirm current availability with the study team.

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