Efficacy assessment
death, SD, tumor
DISEASE PROGRESSION, TUMOR, BRAIN METASTASES, DISEASE, SECONDARY, REMISSION
The primary endpoint was IRC-assessed PFS, according to RECIST 1.1, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first.The secondary endpoints included (1) investigator-assessed PFS, (2) IRC-assessed confirmed ORR, including the proportion of participants who achieved complete response (CR) or partial response (PR), (3) disease control rate (DCR), including the proportion of participants who achieved CR, PR and stable disease (SD), (4) OS, defined as the time from randomization to death from any cause, (5) IRC-assessed DOR, defined as the time from the first date of documented CR or PR to the first onset of disease progression or death from any cause, whichever occurred first, (6) IRC-assessed confirmed CNS-ORR, which was defined as the proportion of participants achieving intracranial CR or intracranial PR among participants with baseline intracranial target lesions assessed by RANO-BM criteria, (7) CNS-DOR, which was defined as the duration of CNS remission in participants with baseline intracranial target lesions, (8) CNS-TTP, which was defined as the time from randomization to the first onset of CNS disease progression (not including death) in participants with baseline brain metastases and participants with baseline intracranial target lesions, and (9) health-related quality-of-life scores, including EORTC QLQ-C30, EORTC QLQ-LC13, EuroQol EQ-5D and visual analogue scale (VAS) scores.The exploratory endpoints included tumor mutational status at baseline and after disease progression, mutations of ALK and other genes, and the rearrangement status of circulating tumor nucleic acids in plasma.