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

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT07063745

This clinical trial evaluates the efficacy of BMS-986504 combined with pembrolizumab and chemotherapy in treating metastatic non-small cell lung cancer with homozygous MTAP deletion. Participants receive either BMS-986504 or a placebo alongside pembrolizumab and chemotherapy agents like cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. Eligibility criteria focus on first-line treatment candidates.

Patient Parameters

Program Overview

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

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

FACILITYZIPCITYSTATE
Alaska Oncology and Hematology99508AnchorageAlaska
Local Institution - 038885054PhoenixArizona
Local Institution - 012085724TucsonArizona
Highlands Oncology Group72762SpringdaleArkansas
Local Institution - 040790033Los AngelesCalifornia
Local Institution - 044490067Los AngelesCalifornia
Local Institution - 015233316Fort LauderdaleFlorida
Local Institution - 038932224JacksonvilleFlorida
Local Institution - 043033709St. PetersburgFlorida
St. Luke's Cancer Institute: Boise83712BoiseIdaho

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