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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: BMS-986504 Dose 1
  • Drug: BMS-986504
    Specified dose on specified days
    Other names:
    • MRTX1719
Experimental
Arm B: BMS-986504 Dose 2
  • Drug: BMS-986504
    Specified dose on specified days
    Other names:
    • MRTX1719

Recruiting Locations

Alaska Oncology and Hematology
Anchorage 5879400, Alaska 5879092 99508
Contact:
Steven Liu, Site 0088
907-257-9851

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Contact:
Pasi Janne, Site 0090
617-632-6036

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
Contact:
Dipesh Uprety, Site 0100
215-285-2261

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Kathryn Arbour, Site 0018
646-608-3792

Gabrail Cancer Center
Canton 5149222, Ohio 5165418 44718
Contact:
Nashat Gabrail, Site 0091
330-417-8231

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Rachel Sanborn, Site 0098
503-215-5696

Fred Hutchison Cancer Center
Seattle 5809844, Washington 5815135 98109
Contact:
Lei Deng, Site 0078
206-606-4801

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.