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Recruiting NCT07063745

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

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 590
Sponsor: Bristol-Myers Squibb

Location: Alaska Oncology and Hematology Anchorage Alaska

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07063745). StuddyBuddy aggregates publicly available trial information.