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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

RecruitingPhase 2/3

A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the 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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 590 · Started: Jan 2, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07063745

Locations in the U.S.

ArizonaMayo Clinic in Arizona - Phoenix, Phoenix
University of Arizona Cancer Center, Tucson
ArkansasHighlands Oncology Group, Springdale
CaliforniaLocal Institution - 0497, Los Alamitos (Not yet recruiting)
USC/Norris Comprehensive Cancer Center, Los Angeles
FloridaHelios Clinical Research - Fort Lauderdale, Fort Lauderdale
Mayo Clinic in Florida, Jacksonville
Local Institution - 0523, Tampa (Not yet recruiting)
IdahoSt. Luke's Cancer Institute: Boise, Boise
IllinoisLocal Institution - 0605, Decatur (Not yet recruiting)
KentuckyBaptist Health Lexington, Lexington
University of Kentucky Chandler Medical Center, Lexington
MaineLocal Institution - 0127, Scarborough (Not yet recruiting)
MassachusettsDana-Farber Cancer Institute, Boston
MichiganLocal Institution - 0418, Ann Arbor (Not yet recruiting)
Local Institution - 0405, Detroit (Not yet recruiting)
Local Institution - 0420, Traverse City (Not yet recruiting)
MinnesotaMayo Clinic in Rochester, Minnesota, Rochester
NebraskaOncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha
New HampshireLocal Institution - 0467, Lebanon (Not yet recruiting)
Local Institution - 0600, Manchester (Not yet recruiting)
New YorkWMCHealth Advanced Physician Services, Hawthorne
Local Institution - 0128, Rochester (Not yet recruiting)
Local Institution - 0518, Schenectady (Not yet recruiting)
North CarolinaLocal Institution - 0514, Winston-Salem (Not yet recruiting)
OhioThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus
OregonKaiser Permanente Interstate Medical Office Central, Portland
Providence Portland Medical Center, Portland
South CarolinaLocal Institution - 0608, Greenville (Not yet recruiting)
TexasLocal Institution - 0433, Dallas (Not yet recruiting)
University of Texas MD Anderson Cancer Center, Houston
UtahHuntsman Cancer Institute, Salt Lake City
VirginiaVirginia Commonwealth University, Richmond
WashingtonFred Hutchinson Cancer Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.