A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Place⦠(NCT07063745) | Clinical Trial Compass
RecruitingPhase 2/3
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
United States590 participantsStarted 2026-01-02
Plain-language 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 pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Progression-free survival (PFS) by RECIST v1.1
Timeframe: Up to 2 years
2
PFS by RECIST v1.1 per BICR
Timeframe: Up to 5 years
3
Overall Survival (OS)
Timeframe: Up to 5 years
Trial details
NCT IDNCT07063745
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2031-08-12
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com