Back to search results

Study of Navlimetostat for Advanced Lung Cancer with MTAP Deletion

This study is testing a drug called Navlimetostat (BMS-986504) for people with advanced or metastatic non-small cell lung cancer (NSCLC). To join, your cancer must have a specific genetic change called a homozygous MTAP deletion, and your cancer must have progressed after previous treatments. The main goal is to see how many participants respond to Navlimetostat, meaning their tumors shrink or disappear, as measured by standard criteria. The study is planned to include 130 participants. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 130 participants.
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 3 years after their last dose of study treatment to assess their response.

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

NCT06855771

A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~130 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:BMS-986504

At a glance

Recruiting sites
66 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured over Up to 3 years after the last participant's last dose of study treatment

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell CarcinomaMTAP Gene

Where it's being run

70 sites across 52 states
Romania4
France3
Madrid, Comunidad de3
Spain3
New York2
Oregon2
New South Wales2
Shandong2

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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
At least 1 measurable lesion as per RECIST v1.1.
Documented radiographic disease progression on or after the most recent line of treatment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
Capability to swallow tablets intact (without chewing or crushing).

Exclusion

Active brain metastases or carcinomatous meningitis.
History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
Prior treatment with a PRMT5 or MAT2A inhibitor.
Known severe hypersensitivity to study treatment and/or any of its excipients.

What this trial measures

  • Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Up to 3 years after the last participant's last dose of study treatment

    OR is defined as confirmed complete response (CR) or partial response (PR)