BMS-986504 plus pembrolizumab and chemotherapy for first-line metastatic NSCLC with MTAP 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 randomized, placebo-controlled phase 2/3 trial enrolls adults with treatment-naive metastatic non-small cell lung cancer who have a homozygous MTAP deletion. Participants receive standard first-line pembrolizumab with platinum-based chemotherapy (cisplatin or carboplatin) and are randomly assigned to also receive either BMS-986504 or matching placebo. BMS-986504 is a selective MTA-cooperative PRMT5 inhibitor intended to exploit the MTAP deletion synthetic vulnerability. Patients are treated until disease progression or unacceptable toxicity and will be followed for outcomes such as tumor response and survival.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion Criteria

* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
* Participants must not have symptomatic brain metastases or spinal cord compression.
* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).

Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.

* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Mayo Clinic in Arizona - Phoenix
  Phoenix, Arizona, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Helios Clinical Research - Fort Lauderdale
  Fort Lauderdale, Florida, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

+271 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.