Endpoints and assessment
death, Tumor, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, TUMOR, BRAIN METASTASES, EVENT, CANCER
The primary endpoint was ORR (the proportion of patients with the best overall response of complete or partial response). Secondary endpoints included PFS (defined as the time from the first dose of study treatment to the documented disease progression or death due to any cause, whichever occurred first; the second progression or death in patients with isolated intracranial progression who continued the study treatment after radiotherapy would be counted as PFS2 event that analyzed in patients with BM), OS (defined as the time from the first dose of study treatment to death due to any cause), and safety.Tumor assessments were done by contrast-enhanced computed tomography or magnetic resonance imaging (MRI; brain metastases were assessed by MRI) at baseline, every two cycles for the first 18 cycles, and every three cycles thereafter. Complete or partial response would be confirmed 4–6 weeks later. Bone scans were conducted when lesions or disease progression in bone were suspected. ORR and PFS were assessed by investigators based on RECIST 1.1. Safety was assessed with laboratory assessments, 12-lead electrocardiograms, echocardiograms, physical examinations, and AEs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 5.0).