The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Specified dose on specified days
Specified dose on specified days
Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 41 months
Overall Survival (OS)
Time frame: Up to approximately 41 months
Overall Response Rate (ORR) as per BICR according to RECIST v1.1
Time frame: Up to approximately 41 months
ORR as per Investigator according to RECIST v1.1
Time frame: Up to approximately 41 months
Duration of Response (DOR) as per BICR according to RECIST v1.1
Time frame: Up to approximately 41 months
DOR as per Investigator according to RECIST v1.1
Time frame: Up to approximately 41 months
Time to Response (TTR) as per BICR according to RECIST v1.1
Time frame: Up to approximately 41 months
TTR as per Investigator according to RECIST v1.1
Time frame: Up to approximately 41 months
PFS as per Investigator according to RECIST v1.1
Time frame: Up to approximately 41 months
Time to intracranial progressions as per BICR according to RECIST v1.1
Time frame: Up to approximately 41 months
Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs
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Local Institution - 0221
Des Moines, Iowa, United States
Local Institution - 0075
Boston, Massachusetts, United States
Local Institution - 0201
Boston, Massachusetts, United States
Local Institution - 0210
Mineola, New York, United States
Local Institution - 0134
New York, New York, United States
Local Institution - 0214
Tacoma, Washington, United States
Local Institution - 0092
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0091
ABB, Buenos Aires F.D., Argentina
Local Institution - 0106
Buenos Aires, Argentina
...and 112 more locations
Time frame: Up to 30 days after last dose
Number of deaths
Time frame: Up to 30 days after last dose
Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score
Time frame: Up to 30 days after last dose