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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.