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.
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.
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.
Sequential
BMS-986504
DrugSpecified dose on specified days
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
OR is defined as confirmed complete response (CR) or partial response (PR)
Number of participants who achieve disease control (DC) as assessed by RECIST v1.1
DC is defined as Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)
Number of participants who achieve clinical benefit (CB) as assessed by RECIST v1.1
CB is defined as BOR of confirmed CR, confirmed PR, or SD for at least 6 months after start of treatment
Duration of response (DOR) as assessed by RECIST v1.1
DOR is defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first)
Progression-free survival (PFS) as assessed by RECIST v1.1
PFS is defined as the time between randomization and the date of disease progression or death from any cause (whichever occurs first)
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