About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BMS-986504