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Study for Metastatic Lung Cancer with MTAP Deletion

This study is for people with metastatic non-small cell lung cancer (cancer that has spread) who have a specific genetic change called a homozygous MTAP deletion. It's testing if adding a drug called Navlimetostat (BMS-986504) to a standard treatment of Pembrolizumab and chemotherapy works better than Pembrolizumab and chemotherapy alone. Navlimetostat is a targeted therapy, and Pembrolizumab is an immunotherapy. The study aims to see if this new combination can help people live longer or prevent their cancer from growing for a longer time. You might be able to join if you have this type of lung cancer and haven't had other treatments for it yet. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 590 participants. It compares two treatment groups: one receiving Navlimetostat, Pembrolizumab, and chemotherapy, and another receiving a placebo, Pembrolizumab, and chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to track how long they live and how long their cancer is controlled.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07063745

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~590 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:BMS-986504PembrolizumabPlaceboCisplatinCarboplatinPemetrexed

At a glance

Recruiting sites
171 of 320 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) by RECIST v1.1
Measured over Up to 2 years
+2 more outcomes measured

Conditions

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Explore related trials

Lung Non-Small Cell CarcinomaMTAP Gene

Where it's being run

320 sites across 190 states
Turkey (Türkiye)8
São Paulo6
Romania6
Bulgaria5
Italy5
Seoul-teukbyeolsi [Seoul]5
Florida4
Texas4

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).
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.

What this trial measures

  • Progression-free survival (PFS) by RECIST v1.1Up to 2 years

    Phase 2

  • PFS by RECIST v1.1 per BICRUp to 5 years

    Phase 3

  • Overall Survival (OS)Up to 5 years

    Phase 3