[Translation] A multicenter, randomized, open, positive-controlled phase III clinical study: Evaluating the efficacy and safety of sutetinib maleate capsules alone versus platinum-containing doublet chemotherapy as the first-line treatment for patients with advanced non-small cell lung cancer and non-classical EGFR mutations
主要目的:评价马来酸苏特替尼胶囊对比含铂双药化疗治疗局部晚期或转移性EGFR非经典突变NSCLC患者的无进展生存期(PFS,由独立中心影像[IRC]评估,基于实体瘤疗效评价标准第1.1版[RECIST 1.1])。
次要目的:评价马来酸苏特替尼胶囊对比含铂双药化疗的PFS(基于研究者评估);总生存期(OS);以及基于IRC评估的:客观缓解率(ORR)、缓解持续时间(DOR)、疾病控制率(DCR)、临床获益率(CBR)。评价马来酸苏特替尼胶囊对比含铂双药化疗治疗局部晚期或转移性NSCLC患者的安全性和耐受性。
[Translation] Primary objective: To evaluate the progression-free survival (PFS, assessed by independent central imaging [IRC], based on Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) of sutetinib maleate capsules versus platinum-based doublet chemotherapy in patients with locally advanced or metastatic EGFR non-classical mutation NSCLC.
Secondary objectives: To evaluate PFS (based on investigator assessment) of sutetinib maleate capsules versus platinum-based doublet chemotherapy; overall survival (OS); and objective response rate (ORR), duration of response (DOR), disease control rate (DCR), and clinical benefit rate (CBR) based on IRC assessment. To evaluate the safety and tolerability of sutetinib maleate capsules versus platinum-based doublet chemotherapy in patients with locally advanced or metastatic NSCLC.