Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

Study summary

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV 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) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 5, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?32 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 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Biological: Nivolumab; Biological: Ipilimumab; Drug: Platinum Doublet Chemotherapy

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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

Men and Women ≥ 18 years of age
Diagnosed with stage IV Non-Small Cell Lung Cancer
Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.

Reasons someone may not be able to joinExclusion criteria

Subjects with untreated CNS metastases are excluded.
Subjects with carcinomatous meningitis
Subjects with an active, known or suspected autoimmune disease.
Subjects with a condition requiring systemic treatment with either corticosteroids ( \> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
Women who are pregnant, plan to become pregnant, and/or breastfeed during the study. 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

Sharp Memorial HospitalSan Diego, California
Cancer Center Of Central ConnecticutPlainville, Connecticut
Cleveland Clinic FloridaWeston, Florida
Winship Cancer Institute.Atlanta, Georgia
Summit Cancer CareSavannah, Georgia
Cancer Center Of KansasWichita, Kansas
University Of Louisville Medical Center, Inc., DbaLouisville, Kentucky
Johns Hopkins Cancer CenterBaltimore, Maryland
Local Institution - 0029Boston, Massachusetts
Local Institution - 0030Boston, Massachusetts
Massachusetts General HospitalBoston, Massachusetts
Henry Ford Health SystemDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 5, 2023. Always confirm current availability with the study team.

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