A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

Study summary

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Cisplatin

Plus 7 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 6, 2026 · 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?138 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: Biological: Nivolumab; Drug: Cisplatin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Biological: Ipilimumab

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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

Early-stage or resectable→

Treatment approach

Immunotherapy→Chemotherapy→

Study topics

Before surgery (neoadjuvant)→After surgery (adjuvant)→

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

Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
Lung function capacity capable of tolerating the proposed lung surgery
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Available tissue of primary lung tumor

Reasons someone may not be able to joinExclusion criteria

Presence of locally advanced, inoperable or metastatic disease
Participants with active, known or suspected autoimmune disease
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) 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

Local Institution - 0121Glendale, Arizona
Local Institution - 0081Los Angeles, California
Local Institution - 0025Denver, Colorado
Local Institution - 0007Plainville, Connecticut
Local Institution - 0173Hollywood, Florida
Local Institution - 0136Miami, Florida
Local Institution - 0054Orlando, Florida
Orlando Health, Inc.Orlando, Florida
Indian River Medical CenterVero Beach, Florida
Northwest Georgia Oncology Center, P.C.Marietta, Georgia
Local Institution - 0015Chicago, Illinois
Local Institution - 0002Chicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2026. Always confirm current availability with the study team.

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