RecruitingPhase 2 / Phase 3NCT07063745

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

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

Checked against the public recordLast updated Aug 25, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 2 / Phase 3
U.S. locations320
SponsorBristol-Myers Squibb
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
Bristol-Myers Squibb
Interventions being studied
Drug: BMS-986504; Drug: Pembrolizumab; Other: Placebo; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel
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

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.

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 - 0119Anchorage, Alaska
  • Mayo Clinic in Arizona - PhoenixPhoenix, Arizona
  • University of Arizona Cancer CenterTucson, Arizona
  • Highlands Oncology GroupSpringdale, Arkansas
  • Local Institution - 0497Los Alamitos, California
  • USC/Norris Comprehensive Cancer CenterLos Angeles, California
  • Local Institution - 0444Los Angeles, California
  • Local Institution - 0606Newark, Delaware
  • Helios Clinical Research - Fort LauderdaleFort Lauderdale, Florida
  • Mayo Clinic in FloridaJacksonville, Florida
  • Local Institution - 0430St. Petersburg, Florida
  • Local Institution - 0523Tampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 25, 2026. Always confirm current availability with the study team.

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