A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Recommended Phase 3 Dose (RP3D) of BMS-986507
Phase 2
Time frame: Approximately 3 months after the first dose
Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Phase 3
Time frame: Up to 3 years
Objective Response (OR) Assessed by RECIST v1.1 per BICR
Phase 2
Time frame: Up to 3 years
PFS Assessed by RECIST v1.1 per BICR
Phase 2
Time frame: Up to 3 years
Overall Survival (OS)
Phase 3
Time frame: Up to 5 years
PFS Assessed by RECIST v1.1 per investigator assessment
Phase 3
Time frame: Up to 3 years
OR Assessed by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 3 years
Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 3 years
Duration of Response (DOR) Assessed by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 3 years
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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CONTACT
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Specified dose on specified days
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building
Irvine, California, United States
RECRUITINGUniversity of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
RECRUITINGShaw Cancer Center
Edwards, Colorado, United States
RECRUITINGLocal Institution - 0085
Gainesville, Florida, United States
WITHDRAWNLocal Institution - 0142
Pembroke Pines, Florida, United States
NOT_YET_RECRUITINGPiedmont Healthcare
Atlanta, Georgia, United States
RECRUITINGJohn B Amos Cancer Center
Columbus, Georgia, United States
RECRUITINGRush University Medical Center
Chicago, Illinois, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITING...and 175 more locations
Time To Response (TTR) Assessed by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 3 years