[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of VIC-1911 combined with osimertinib in patients with advanced non-small cell lung cancer resistant to third-generation EGFR-TKI
剂量递增阶段: 主要目的: 评估 VIC-1911 片联用奥希替尼治疗晚期非小细胞肺癌患者的安全性和耐受性; 次要目的: 通过剂量限制性毒性(DLT)的发生率,在试验剂量下确定 VIC-1911 联用奥希替尼的最大耐受剂量(MTD),为 Ib 期给药剂量提供依据; 评估 VIC-1911 片联用奥希替尼在晚期非小细胞肺癌患者中的药代动力学(PK)特征; 评估 VIC-1911 片联用奥希替尼在晚期非小细胞肺癌患者中的初步疗效
扩展阶段: 主要目的: 评估在推荐剂量下,VIC-1911 片联用奥希替尼治疗晚期非小细胞肺癌患者的安全性; 次要目的: 确定 II 期推荐剂量(RP2D),为后续的临床研究提供依据; 评估在推荐剂量下,VIC-1911 片联用奥希替尼在晚期非小细胞肺癌患者中的 PK 特征; 评估在推荐剂量下,VIC-1911 片联用奥希替尼在晚期非小细胞肺癌患者中的初步疗效。
[Translation] Dose escalation phase: Primary objective: To evaluate the safety and tolerability of VIC-1911 tablets combined with osimertinib in the treatment of patients with advanced non-small cell lung cancer; Secondary objective: To determine the maximum tolerated dose (MTD) of VIC-1911 combined with osimertinib at the test dose by the incidence of dose-limiting toxicity (DLT) to provide a basis for the Phase Ib dosing; To evaluate the pharmacokinetic (PK) characteristics of VIC-1911 tablets combined with osimertinib in patients with advanced non-small cell lung cancer; To evaluate the preliminary efficacy of VIC-1911 tablets combined with osimertinib in patients with advanced non-small cell lung cancer
Extension phase: Primary objective: To evaluate the safety of VIC-1911 tablets combined with osimertinib in the treatment of patients with advanced non-small cell lung cancer at the recommended dose; Secondary objective: To determine the Phase II recommended dose (RP2D) to provide a basis for subsequent clinical studies; To evaluate the PK characteristics of VIC-1911 tablets combined with osimertinib in patients with advanced non-small cell lung cancer at the recommended dose; To evaluate the preliminary efficacy of VIC-1911 tablets in combination with osimertinib at the recommended dose in patients with advanced non-small cell lung cancer.