A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemother… (NCT07063745) | Clinical Trial Compass
RecruitingPhase 2/3
A Study to Compare the Combination of Navlimetostat (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 States, Argentina, Australia590 participantsStarted 2026-01-02
Plain-language summary
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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