Avistone (Ningbo) Biotechnology Co., Ltd.

Phase Ib escalation primary objective: To evaluate the tolerability and safety of PLB1004 combined with platinum-based doublet chemotherapy in subjects with EGFR mutation-positive NSCLC and confirm its maximum tolerated dose and/or recommended dose for combined use. Secondary: To evaluate the PK characteristics of PLB1004 and evaluate the efficacy of PLB1004 combined with platinum-based doublet chemotherapy. Phase Ib extension primary objective: To evaluate the efficacy of PLB1004 combined with platinum-based doublet chemotherapy in subjects with EGFR mutation-positive NSCLC and simultaneously confirm its RP2D in Phase II clinical trial. Secondary: To evaluate other efficacy indicators of PLB1004 combined with platinum-based doublet chemotherapy and evaluate its tolerability and safety in subjects, and to evaluate the PK characteristics of PLB1004. Phase II primary objective: To evaluate the efficacy of PLB1004 combined with platinum-based doublet chemotherapy in subjects with locally advanced or metastatic NSCLC with EGFR mutation-positive at RP2D and its efficacy in subjects with newly diagnosed resectable stage II-III NSCLC with EGFR mutation-positive. Secondary: Further evaluate the efficacy in subjects with locally advanced or metastatic NSCLC and newly diagnosed resectable stage II-III NSCLC with EGFR mutations at RP2D. Simultaneously evaluate its tolerability and safety in subjects. And evaluate the pharmacokinetic characteristics of PLB1004. Exploratory: Explore the resistance mechanism of PLB1004