Status:

RECRUITING

A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus p...

Eligibility Criteria

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.

Key Trial Info

Start Date :

January 2 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 12 2031

Estimated Enrollment :

590 Patients enrolled

Trial Details

Trial ID

NCT07063745

Start Date

January 2 2026

End Date

August 12 2031

Last Update

April 7 2026

Active Locations (264)

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Page 1 of 66 (264 locations)

1

Alaska Oncology and Hematology

Anchorage, Alaska, United States, 99508

2

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States, 85054

3

Local Institution - 0120

Tucson, Arizona, United States, 85724

4

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion | DecenTrialz