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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

NCT07063745

RecruitingPhase 2, Phase 3

Sponsor: Bristol-Myers Squibb

Conditions: Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Interventions: BMS-986504, Pembrolizumab, Placebo, Cisplatin, Carboplatin

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (319)

Anchorage, Alaska, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Springdale, Arkansas, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newark, Delaware, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Boise, Idaho, United States
Decatur, Illinois, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Scarborough, Maine, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Traverse City, Michigan, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Manchester, New Hampshire, United States
Hawthorne, New York, United States
Rochester, New York, United States
Schenectady, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
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