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

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT06855771

This clinical trial evaluates the safety and efficacy of BMS-986504 in advanced or metastatic NSCLC patients with homozygous MTAP deletion. Eligible participants must have progressed on prior therapies, have measurable lesions, and an ECOG status of 0-1. The intervention involves administering a specified dose of BMS-986504. Participants must be adults capable of swallowing tablets intact.

Patient Parameters

Program Overview

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.

Eligibility 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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 008899508AnchorageAlaska
Local Institution - 009983712BoiseIdaho
Local Institution - 009002215BostonMassachusetts
Local Institution - 010048201DetroitMichigan
Local Institution - 001810065New YorkNew York
Local Institution - 007911967ShirleyNew York
Local Institution - 009144718CantonOhio
Local Institution - 009897225PortlandOregon
Local Institution - 010397239PortlandOregon
Local Institution - 010277030HoustonTexas

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