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

Description

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.

Conditions

Carcinoma, Non-Small-Cell Lung

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Study Overview

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Study Details

Study 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.

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

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Anchorage

Local Institution - 0088, Anchorage, Alaska, United States, 99508

Boise

Local Institution - 0099, Boise, Idaho, United States, 83712

Boston

Local Institution - 0090, Boston, Massachusetts, United States, 02215

Detroit

Local Institution - 0100, Detroit, Michigan, United States, 48201

New York

Local Institution - 0018, New York, New York, United States, 10065

Shirley

Local Institution - 0079, Shirley, New York, United States, 11967

Canton

Local Institution - 0091, Canton, Ohio, United States, 44718

Portland

Local Institution - 0098, Portland, Oregon, United States, 97225

Portland

Local Institution - 0103, Portland, Oregon, United States, 97239

Houston

Local Institution - 0102, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-12-30