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A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06855771.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium