CompletedPhase 3NCT04026412
Official study title

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

Study summary

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiednivolumab and ipilimumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 24, 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?183 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

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; Biological: ipilimumab; Biological: durvalumab
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

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
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
  • Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
Reasons someone may not be able to joinExclusion criteria
  • Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
  • Active infection requiring systemic therapy within 14 days prior to randomization
  • History of organ or tissue transplant that requires systemic use of immune suppressive agents
  • Prior thoracic radiotherapy 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.

04
Study sites

U.S. locations

  • Local Institution - 0119La Jolla, California
  • Local Institution - 0207San Francisco, California
  • Local Institution - 0166San Francisco, California
  • Local Institution - 0129Lone Tree, Colorado
  • Local Institution - 0233Jacksonville, Florida
  • Local Institution - 0219Orlando, Florida
  • Local Institution - 0039Pensacola, Florida
  • Local Institution - 0125Atlanta, Georgia
  • Local Institution - 0165Augusta, Georgia
  • Local Institution - 0218Edgewood, Kentucky
  • Local Institution - 0108Bethesda, Maryland
  • Local Institution - 0116Traverse City, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 24, 2025. Always confirm current availability with the study team.

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