A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung… (NCT06855771) | Clinical Trial Compass
RecruitingPhase 2
A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)
United States130 participantsStarted 2025-09-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Up to 3 years after the last participant's last dose of study treatment
Trial details
NCT IDNCT06855771
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-12-29
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com