RecruitingCarcinoma, Non-Small-Cell Lung

A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (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

You may qualify if…

✓ 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).

You may not qualify if…

✕ 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.