[Translation] A multicenter, open-label phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BR790 tablets combined with anlotinib hydrochloride capsules in patients with advanced non-small cell lung cancer
主要目的:
第一阶段(剂量递增阶段): 评价BR790片联合盐酸安罗替尼胶囊治疗晚期非小细胞肺癌患者的安全性和耐受性,确定联合治疗的最大耐受剂量和推荐的II期临床试验联合治疗的剂量;
第二阶段(剂量扩展阶段): 评价BR790片联合盐酸安罗替尼胶囊治疗晚期非小细胞肺癌的有效性(按照实体瘤评价标准RECIST V1.1进行评估)。 次要目的:评价联合给药时BR790和安罗替尼的药代动力学(PK)特征,以及初步评价两药联合使用时安罗替尼对BR790 PK的影响。 探索性目的:
1、回顾性分析肿瘤KRAS、BRAF、NF1等基因异常与疗效之间的关系;
2、探索剂量-暴露-响应之间的关系。
[Translation] Main purpose:
Phase I (dose escalation phase): To evaluate the safety and tolerability of BR790 tablets combined with anlotinib hydrochloride capsules in the treatment of patients with advanced non-small cell lung cancer, and to determine the maximum tolerated dose of the combination therapy and the recommended dose of the combination therapy in Phase II clinical trials;
Phase II (dose expansion phase): To evaluate the effectiveness of BR790 tablets combined with anlotinib hydrochloride capsules in the treatment of advanced non-small cell lung cancer (assessed according to the solid tumor evaluation standard RECIST V1.1). Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of BR790 and anlotinib when administered in combination, and to preliminarily evaluate the effect of anlotinib on BR790 PK when the two drugs are used in combination. Exploratory purpose:
1. Retrospectively analyze the relationship between tumor KRAS, BRAF, NF1 and other genetic abnormalities and efficacy;
2. Explore the relationship between dose-exposure-response.