[Translation] A multicenter, open-label, Phase IIb study evaluating sutertinib maleate capsules in patients with locally advanced or metastatic non-small cell lung cancer (only non-resistant rare EGFR mutations, including L861Q, G719X and/or S768I) efficacy and safety
主要目的:评价马来酸苏特替尼胶囊治疗局部晚期或转移性NSCLC患者(仅限非耐药性罕见EGFR突变,包括L861Q、G719X和/或S768I)的有效性。
次要目的: 评价马来酸苏特替尼胶囊治疗局部晚期或转移性NSCLC患者(仅限非耐药性罕见EGFR突变,包括L861Q、G719X和/或S768I)的安全性。 评价马来酸苏特替尼胶囊治疗局部晚期或转移性NSCLC患者(仅限非耐药性罕见EGFR突变,包括L861Q、G719X和/或S768I)的群体药代动力学(PPK)特征。
[Translation] Main objective: To evaluate the efficacy of sutertinib maleate capsules in the treatment of patients with locally advanced or metastatic NSCLC (limited to non-resistant rare EGFR mutations, including L861Q, G719X and/or S768I).
Secondary objectives: To evaluate the safety of sutertinib maleate capsules in patients with locally advanced or metastatic NSCLC (only non-resistant rare EGFR mutations, including L861Q, G719X and/or S768I). To evaluate the population pharmacokinetic (PPK) profile of sutertinib maleate capsules in patients with locally advanced or metastatic NSCLC (non-resistant rare EGFR mutations only, including L861Q, G719X and/or S768I).