A Study of BMS-986504 in Participants with Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer with Homozygous MTAP 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2021250039

Enrollment

Registered

2025-12-19

Start date

2025-01-26

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Two arm, BMS-986504 Specified dose on specified days

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	—

Secondary

Measure	Time frame
Number of participants who achieve disease control (DC) as assessed by RECIST v1.1	—

Countries

Australia, China, France, Germany, Italy, Japan, Poland, Romania, Spain, Sweden, UK, US

Contacts

Public ContactJoseph Hreiki

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026