Study Comparing BMS-986504 with Pembrolizumab and Chemotherapy Versus Placebo in First-line Treatment for Metastatic Non-small Cell Lung Cancer with MTAP Deletion

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT07063745

This clinical trial is testing whether adding a new drug, BMS-986504, to the standard treatment of pembrolizumab and chemotherapy can provide better outcomes for patients with metastatic non-small cell lung cancer who have a specific genetic deletion called MTAP.

Patient Parameters

Program Overview

The goal of this study is to find out if combining a new drug, BMS-986504, with pembrolizumab and chemotherapy is more effective than using a placebo with pembrolizumab and chemotherapy for treating patients with metastatic non-small cell lung cancer (NSCLC) who have a genetic deletion known as MTAP. This study aims to determine if the new combination can offer better clinical benefits for these patients.

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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