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Looking for participantsPhase2/Phase3

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

Sponsor: Bristol-Myers Squibb

NCT ID: NCT07063745

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BMS-986504 (drug), Pembrolizumab (drug), Placebo (other), Cisplatin (drug)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
BMS-986504 — drug: Specified dose on specified days · Pembrolizumab — drug: Specified dose on specified days · Placebo — other: Specified dose on specified days · Cisplatin — drug: Specified dose on specified days · Carboplatin — drug: Specified dose on specified days · Pemetrexed — drug: Specified dose on specified days · Paclitaxel — drug: Specified dose on specified days · Nab-paclitaxel — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
590
Started
2026-01-02
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic non-small cell lung cancer with mtap deletion
  • • Phase2/Phase3 - 590 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic non-small cell lung cancer with mtap deletion

Where?

  • • Leicester - Leicester Royal Infirmary
  • • London - Sarah Cannon Research Institute UK

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • ✓ at least 1 measurable lesion as per RECIST v1
  • ✓ immediate treatment if clinically indicated

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participants must have confirmed by a biopsy diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase...
  • ✓Participants must have an activity scale (ECOG) performance status of 0-1.
  • ✓Participants must have at least 1 measurable lesion as per (standard scan measurements).
  • ✓Exclusion Criteria
See the full 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 Is This Study? (2 UK sites)

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Sean Dulloo, Site 0033441162586318

Sarah Cannon Research Institute UK

London w1g 6ad, United Kingdom

Recruiting
Site contact (verified)
Elisa Fontana, Site 022802070348460

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09