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

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: BMS-986504

Study type

Interventional

Funder types

Industry

Identifiers

NCT06855771

U1111-1315-9473 (Other Identifier)

2024-519814-29 (Other Identifier)

CA240-0009

Details and patient eligibility

About

The purpose of this study is to evaluate 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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.