RecruitingPhase 2NCT06855771
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)
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
Sponsor
Bristol-Myers Squibb
Enrollment
130 participants
Start Date
Sep 9, 2025
Study Type
INTERVENTIONAL
Summary
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria4
- 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.
Interventions
DRUGBMS-986504
Specified dose on specified days
Locations(71)
View Full Details on ClinicalTrials.gov
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NCT06855771