NIPH Clinical Trials Search

A Study of BMS-986504 in Participants with Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer with Homozygous MTAP Deletion

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Carcinoma, Non-Small-Cell Lung
Date of first enrollment	26/01/2025
Target sample size	3
Countries of recruitment	US,Japan,Australia,Japan,UK,Japan,France,Japan,Germany,Japan,Sweden,Japan,Poland,Japan,Italy,Japan,Spain,Japan,Romania,Japan,China,Japan
Study type	Interventional
Intervention(s)	Two arm, BMS-986504 Specified dose on specified days

Outcome(s)

Primary Outcome	Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcome	Number of participants who achieve disease control (DC) as assessed by RECIST v1.1

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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).
Exclude 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.