The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
850
Specified dose on specified days
Specified dose on days
Specified dose on specified days
Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
PFS assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
Second Progression-Free Survival (PFS2) as assessed by the Investigator
Time frame: Up to approximately 5 years
Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1
Time frame: Up to approximately 3 years
Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
Duration of Response (DOR) assessed by the BICR as per RECIST v1.1
Time frame: Up to approximately 3 years
Duration of Response (DOR) assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
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Specified dose on specified days
Specified dose on specified days
Local Institution - 0212
Beverly Hills, California, United States
Local Institution - 0504
Fullerton, California, United States
Local Institution - 0357
La Jolla, California, United States
Local Institution - 0520
Pueblo, Colorado, United States
Local Institution - 0527
Fort Myers, Florida, United States
Local Institution - 0366
Orlando, Florida, United States
Local Institution - 0519
Palm Bay, Florida, United States
Local Institution - 0526
St. Petersburg, Florida, United States
Local Institution - 0524
West Palm Beach, Florida, United States
Local Institution - 0210
Honolulu, Hawaii, United States
...and 198 more locations