A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

Study summary

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Ipilimumab

Plus 3 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 28, 2023 · 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?109 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; Biological: Ipilimumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

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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)→

Biomarkers

EGFR→

Treatment approach

Immunotherapy→Targeted therapy→Chemotherapy→

Study topics

After prior treatment→

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

Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib). In osimertinib treated subjects, T790 testing is not required.
No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy. For participants who were treated with osimertinib, T790M testing is not required.
Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC).
Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.
Eastern Cooperative Group (ECOG) Performance Status 0-1
Life expectancy is at least 3 months

Reasons someone may not be able to joinExclusion criteria

Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.
who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
Carcinomatous meningitis
Active, known or suspected autoimmune disease are excluded
ALK translocation
Known SCLC transformation
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 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

Pacific Shores Medical GroupLong Beach, California
Local Institution - 0029Los Angeles, California
Local Institution - 0033Los Angeles, California
Local Institution - 0061Orange, California
Torrance Memorial Physican NetworkRedondo Beach, California
Local Institution - 0003New Haven, Connecticut
Local Institution - 0004Chicago, Illinois
Johns Hopkins UniversityBaltimore, Maryland
Local Institution - 0002Boston, Massachusetts
Beth Israel Deaconess Medical CenterBoston, Massachusetts
Dana Farber Cancer InstituteBoston, Massachusetts
Local Institution - 0064New York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 28, 2023. Always confirm current availability with the study team.

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