[Translation] A study to evaluate the efficacy of BCD-100 in combination with pemetrexed + cisplatin/carboplatin versus placebo in combination with pemetrexed + cisplatin/carboplatin as first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC) and safety of an international, multicenter, randomized, double-blind, placebo-controlled clinical trial
主要目的:
使用OS评价和比较BCD-100联合培美曲塞+顺铂/卡铂和安慰剂联合培美曲塞+顺铂/卡铂作为一线治疗用于转移性非小细胞肺癌受试者的疗效;
次要目的:
使用ORR和PFS(由BICR根据RECIST 1.1进行评估)评价和比较BCD-100联合培美曲塞+顺铂/卡铂和安慰剂联合培美曲塞+顺铂/卡铂作为一线治疗用于转移性非小细胞肺癌受试者的疗效;
使用OS、PFS、ORR、DCR根据PD-L1表达状态评价BCD-100联合培美曲塞+顺铂/卡铂对比安慰剂联合培美曲塞+顺铂/卡铂的疗效。
评价和比较BCD-100联合培美曲塞+顺铂/卡铂和安慰剂联合培美曲塞+顺铂/卡铂作为一线治疗用于转移性非小细胞肺癌受试者的安全性;
[Translation] main purpose:
To evaluate and compare the efficacy of BCD-100 combined with pemetrexed + cisplatin/carboplatin and placebo combined with pemetrexed + cisplatin/carboplatin as first-line treatment for patients with metastatic non-small cell lung cancer using OS;
Secondary purpose:
Using ORR and PFS (assessed by BICR according to RECIST 1.1) to evaluate and compare BCD-100 in combination with pemetrexed + cisplatin/carboplatin and placebo in combination with pemetrexed + cisplatin/carboplatin as first-line therapy for metastases efficacy in subjects with non-small cell lung cancer;
The efficacy of BCD-100 combined with pemetrexed + cisplatin/carboplatin versus placebo combined with pemetrexed + cisplatin/carboplatin was evaluated using OS, PFS, ORR, and DCR according to PD-L1 expression status.
To evaluate and compare the safety of BCD-100 combined with pemetrexed + cisplatin/carboplatin and placebo combined with pemetrexed + cisplatin/carboplatin as first-line therapy in subjects with metastatic non-small cell lung cancer;