A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion
Sponsor: Bristol-Myers Squibb
Sponsor score: 60
ClinicalTrials ID:NCT06855771
This clinical trial evaluates the safety and efficacy of BMS-986504 in advanced or metastatic NSCLC patients with homozygous MTAP deletion. Eligible participants must have progressed on prior therapies, have measurable lesions, and an ECOG status of 0-1. The intervention involves administering a specified dose of BMS-986504. Participants must be adults capable of swallowing tablets intact.
Patient Parameters
| Parameter | Options |
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Program Overview
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 Criteria
Inclusion 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).
Exclusion 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0088 | 99508 | Anchorage | Alaska |
| Local Institution - 0099 | 83712 | Boise | Idaho |
| Local Institution - 0090 | 02215 | Boston | Massachusetts |
| Local Institution - 0100 | 48201 | Detroit | Michigan |
| Local Institution - 0018 | 10065 | New York | New York |
| Local Institution - 0079 | 11967 | Shirley | New York |
| Local Institution - 0091 | 44718 | Canton | Ohio |
| Local Institution - 0098 | 97225 | Portland | Oregon |
| Local Institution - 0103 | 97239 | Portland | Oregon |
| Local Institution - 0102 | 77030 | Houston | Texas |
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