[Translation] A multicenter, randomized, open-label phase II clinical trial evaluating the efficacy and safety of IBR854 cell injection combined with pemetrexed + cisplatin versus pemetrexed + cisplatin as first-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer.
主要目的:评价IBR854细胞注射液联合培美曲塞+顺铂对比培美曲塞+顺铂在局部晚期或者转移性非鳞状非小细胞肺癌患者中的初步有效性。次要目的:1)评价IBR854细胞注射液联合培美曲塞+顺铂对比培美曲塞+顺铂在局部晚期或者转移性非鳞状非小细胞肺癌患者中的安全性。2)评价IBR854细胞注射液联合培美曲塞+顺铂给药后的药代动力学特征。3)评价IBR854细胞注射液的免疫原性。探索性目的:1)评价细胞因子释放谱及其与临床疗效和安全性的相关性。2)探索5T4表达水平与临床疗效的相关性。
[Translation] Primary Objective: To evaluate the preliminary efficacy of IBR854 cell injection combined with pemetrexed + cisplatin versus pemetrexed + cisplatin in patients with locally advanced or metastatic non-squamous non-small cell lung cancer. Secondary Objectives: 1) To evaluate the safety of IBR854 cell injection combined with pemetrexed + cisplatin versus pemetrexed + cisplatin in patients with locally advanced or metastatic non-squamous non-small cell lung cancer. 2) To evaluate the pharmacokinetic characteristics of IBR854 cell injection combined with pemetrexed + cisplatin after administration. 3) To evaluate the immunogenicity of IBR854 cell injection. Exploratory Objectives: 1) To evaluate the cytokine release profile and its correlation with clinical efficacy and safety. 2) To explore the correlation between 5T4 expression levels and clinical efficacy.