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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
590
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Alaska Oncology and Hematology
Anchorage, Alaska, United States
RECRUITINGMayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
RECRUITINGLocal Institution - 0120
Tucson, Arizona, United States
NOT_YET_RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
Progression-free survival (PFS) by RECIST v1.1
Phase 2
Time frame: Up to 2 years
PFS by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 5 years
Overall Survival (OS)
Phase 3
Time frame: Up to 5 years
Objective response (OR) (confirmed complete response (CR) or partial response (PR))
Phase 2
Time frame: Up to 2 years
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
Phase 2
Time frame: Up to 2 years
Duration of response (DOR) (CR or PR)
Phase 2
Time frame: Up to 2 years
Time to objective response (TTOR) (CR or PR)
Phase 2
Time frame: Up to 2 years
Number of participants with treatment-related and all-cause adverse events (AEs)
Phase 2
Time frame: Up to 90 days from the last dose
Number of participants with serious adverse events (SAEs) including fatal AEs
Phase 2
Time frame: Up to 90 days from the last dose
Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation
Phase 2
Time frame: Up to 90 days from the last dose
Number of participants with laboratory abnormalities
Phase 2
Time frame: Up to 90 days from the last dose
OR (confirmed CR or PR)
Phase 3
Time frame: Up to 5 years
Disease control (BOR of confirmed CR, confirmed PR, or SD)
Phase 3
Time frame: Up to 5 years
DOR (CR or PR)
Phase 3
Time frame: Up to 5 years
PFS by RECIST v1.1 per Investigator
Phase 3
Time frame: Up to 5 years
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CONTACT
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CONTACT
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGLocal Institution - 0444
Los Angeles, California, United States
NOT_YET_RECRUITINGLocal Institution - 0152
Fort Lauderdale, Florida, United States
NOT_YET_RECRUITINGMayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGLocal Institution - 0430
St. Petersburg, Florida, United States
WITHDRAWNSt. Luke's Cancer Institute: Boise
Boise, Idaho, United States
RECRUITING...and 254 more locations