[Translation] REPLATINUM: A controlled, open-label, international randomized phase III study of RRx-001 administered sequentially with platinum-based doublet therapy or platinum-based doublet therapy alone as third-line or subsequent treatment of small cell lung cancer
比较双重主要有效性终点,包括无进展生存期(PFS)和总生存期(OS),PFS 定义为两组从随机分组至疾病进展(RECIST 1.1)或全因死亡之间的时间。疾病进展是由盲态独立中心审查(BICR)根据 RECIST 1.1 评估的,这是PFS 定义的依据。OS 定义为从随机分组至全因死亡的时间。
[Translation] Dual primary efficacy endpoints were compared, including progression-free survival (PFS) and overall survival (OS), defined as the time from randomization to disease progression (RECIST 1.1) or all-cause death between the two groups. Disease progression was assessed by blinded independent central review (BICR) according to RECIST 1.1, which is the basis for the definition of PFS. OS was defined as the time from randomization to death from any cause.