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Evaluating BMS-986504 for advanced lung cancer with specific genetic deletion

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies

Phase 2 Interventional Bristol-Myers Squibb · NCT06855771

This study is testing a new drug called BMS-986504 to see if it can help people with advanced lung cancer who have a specific genetic change and have not responded to previous treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment130 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations71 sites (Anchorage, Alaska and 70 other locations)
Trial IDNCT06855771 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of BMS-986504 as a monotherapy in patients with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) who have a homozygous MTAP deletion and have previously undergone treatment. Participants must have documented disease progression after prior therapies and be willing to provide tumor samples for genetic confirmation. The study will focus on patients who have measurable lesions and meet specific performance status criteria.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic NSCLC exhibiting homozygous MTAP deletion and who have progressed after prior treatments.

Not a fit: Patients with active brain metastases or significant gastrointestinal diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a specific genetic profile of lung cancer.

How similar studies have performed: While this approach is focused on a specific genetic deletion, similar targeted therapies have shown promise in other studies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* 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 Criteria

* 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.
* Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

Anchorage, Alaska and 70 other locations

+21 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 Carcinoma, Non-Small-Cell Lung
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.