Evaluating BMS-986504 for advanced lung cancer with specific genetic deletion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and effectiveness of BMS-986504 as a monotherapy in patients with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) who have a homozygous MTAP deletion and have previously undergone treatment. Participants must have documented disease progression after prior therapies and be willing to provide tumor samples for genetic confirmation. The study will focus on patients who have measurable lesions and meet specific performance status criteria.

Why it matters

Who can join: the full rules

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).
* For combination arms

  1. Participants must have documented evidence of EGFR status.
  2. Participants with EGFR mutant or wild type NSCLC are allowed.

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.
* For combination arms

  a. Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab.
* Other protocol-defined inclusion/exclusion criteria apply.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Gabrail Cancer Center
  Canton, Ohio, United States Recruiting
• Providence Portland Medical Center
  Portland, Oregon, United States Recruiting

+17 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.