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Phase 2Recruiting

A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Sponsored by Bristol-Myers Squibb

About this study

The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion

Where this study is enrolling (19)

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona

    Call +1 480-515-6296

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  • University of Arizona Cancer Center

    Tucson, Arizona

    Call 850-557-2723

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  • Highlands Oncology Group

    Springdale, Arkansas

    Call 479-872-8130

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  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California

    Call 323-865-3000

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  • Helios Clinical Research - Fort Lauderdale

    Fort Lauderdale, Florida

    Call 239-938-9315

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Show all 19 locations

  • Mayo Clinic in Florida

    Jacksonville, Florida

    Call 904-953-0315

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  • Baptist Health Lexington

    Lexington, Kentucky

    Call 859-260-6100

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  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky

    Call 859-323-6522

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  • Dana-Farber Cancer Institute

    Boston, Massachusetts

    Call 617-632-6036

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  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota

    Call 507-284-2511

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  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska

    Call 402-593-3141

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  • WMCHealth Advanced Physician Services

    Hawthorne, New York

    Call 914-493-8375

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  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio

    Call 412-864-7859

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  • Providence Portland Medical Center

    Portland, Oregon

    Call 503-215-5696

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  • Kaiser Permanente Interstate Medical Office Central

    Portland, Oregon

    Call 503-249-3315

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  • University of Texas MD Anderson Cancer Center

    Houston, Texas

    Call 877-632-6789

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  • Huntsman Cancer Institute

    Salt Lake City, Utah

    Call 801-587-4557

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  • Virginia Commonwealth University

    Richmond, Virginia

    Call 804-828-7999

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  • Fred Hutchinson Cancer Center

    Seattle, Washington

    Call 206-606-4801

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Who can participate

Inclusion criteria

  • ✓Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
  • ✓Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
  • ✓Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • ✓Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion criteria

  • ✕Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
  • ✕Participants must not have symptomatic brain metastases or spinal cord compression.
  • ✕Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).
  • ✕Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
  • ✕Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
  • ✕Other protocol-defined Inclusion/Exclusion criteria apply.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.