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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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