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BMS-986504 plus pembrolizumab and chemotherapy for first-line metastatic NSCLC with MTAP deletion

A Randomized Phase 2/3 Study of 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

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT07063745

This study will test whether adding BMS-986504 to pembrolizumab and platinum chemotherapy helps people with first-line metastatic NSCLC who have a homozygous MTAP deletion.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment590 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, pembrolizumab
Locations277 sites (Anchorage, Alaska and 276 other locations)
Trial IDNCT07063745 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled phase 2/3 trial enrolls adults with treatment-naive metastatic non-small cell lung cancer who have a homozygous MTAP deletion. Participants receive standard first-line pembrolizumab with platinum-based chemotherapy (cisplatin or carboplatin) and are randomly assigned to also receive either BMS-986504 or matching placebo. BMS-986504 is a selective MTA-cooperative PRMT5 inhibitor intended to exploit the MTAP deletion synthetic vulnerability. Patients are treated until disease progression or unacceptable toxicity and will be followed for outcomes such as tumor response and survival.

Who should consider this trial

Good fit: Adults with metastatic (stage IV or recurrent) NSCLC who are treatment-naive for metastatic disease, have a confirmed homozygous MTAP deletion, ECOG 0–1, and at least one measurable lesion per RECIST v1.1.

Not a fit: Patients with actionable targetable oncogenic mutations who have a standard first-line targeted therapy option, those with symptomatic brain metastases or spinal cord compression, prior systemic therapy for metastatic disease, or poor performance status are unlikely to benefit from or be eligible for this study.

Why it matters

Potential benefit: If successful, adding BMS-986504 could improve response rates and survival for patients with MTAP-deleted metastatic NSCLC.

How similar studies have performed: PRMT5 inhibitors are an emerging therapeutic class with encouraging preclinical data and early-phase signals, but combining a PRMT5 inhibitor with PD-1 blockade and chemotherapy in MTAP-deleted NSCLC is largely novel and not yet proven in randomized trials.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Anchorage, Alaska and 276 other locations

+227 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Non-small Cell Lung Cancer With MTAP DeletionPRMT5Lung cancerNSCLCMTAPCDKN2AMRTX1719First-line
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.