適應症
Safety Run-In
•Type, incidence, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities
•Incidence of dose-limiting toxicities (DLTs), AEs graded according to NCI CTCAE v5.0, and dose reductions or modifications
Phase 3 Study (Each Objective Applies to Cohorts 1 and 2 Independently)
•Overall PFS using the KM method, where PFS is defined as the time from randomization to death or the first documented radiologically confirmed disease progression, whichever occurs first, using RECIST v1.1, as determined based on BICR
