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)

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Ipilimumab

Plus 5 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?290 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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/

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

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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