Active Not RecruitingPhase 3NCT04025879

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Checked against the public recordLast updated Aug 26, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations108
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: Nivolumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Placebo; Drug: Docetaxel
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: * Participants with suspected or histologically confirmed Stage IIA (\> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable * No brain metastasis * Treatment-naive for NSCLC (no prior systemic anti-cancer treatment) * Ability to provide surgical or biopsy tumor tissue for biomarkers * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 Exclusion Criteria: * Participants with an active, known or suspected autoimmune disease * Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) * Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC * Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 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

  • Local Institution - 0104Tampa, Florida
  • Local Institution - 0040Atlanta, Georgia
  • Local Institution - 0120Augusta, Georgia
  • Local Institution - 0145Chicago, Illinois
  • Local Institution - 0078Chicago, Illinois
  • Local Institution - 0121Orland Park, Illinois
  • Rcca Md LlcBethesda, Maryland
  • Local Institution - 0076Boston, Massachusetts
  • Local Institution - 0074Newton, Massachusetts
  • Local Institution - 0086Traverse City, Michigan
  • Local Institution - 0100Lebanon, New Hampshire
  • Local Institution - 0055Cincinnati, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 26, 2026. Always confirm current availability with the study team.

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