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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

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 diagnosed by tissue sample (biopsy-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 previous cancer treatment that works throughout the body (like chemotherapy) (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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

BMS-986504

Specified dose on specified days

DRUG

Pembrolizumab

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Paclitaxel

Specified dose on specified days

DRUG

Nab-paclitaxel

Specified dose on specified days

Locations (20)

Alaska Oncology and Hematology
Anchorage, Alaska, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
Local Institution - 0120
Tucson, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution - 0444
Los Angeles, California, United States
Local Institution - 0152
Fort Lauderdale, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Local Institution - 0430
St. Petersburg, Florida, United States
St. Luke's Cancer Institute: Boise
Boise, Idaho, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Local Institution - 0127
Scarborough, Maine, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Local Institution - 0418
Ann Arbor, Michigan, United States
Local Institution - 0405
Detroit, Michigan, United States
Local Institution - 0420
Traverse City, Michigan, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Local Institution - 0467
Lebanon, New Hampshire, United States