Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive

This study is a multicenter, open-label, dose-escalation and dose-expansion Ib/II phase study, aiming to evaluate the clinical safety, tolerability, PK and preliminary efficacy of PLB1004 combined with platinum-based doublet chemotherapy in NSCLC patients with EGFR mutations. The study consists of two parts: the phase Ib dose-escalation study and dose-expansion study, as well as the phase II clinical study. The target population of the phase Ib study is patients with confirmed locally advanced or metastatic NSCLC harboring EGFR mutations who have received or not received systemic antitumor therapy. The II phase clinical study sets up two cohorts. Cohort 1: patients with confirmed locally advanced or metastatic NSCLC harboring EGFR mutations who have received or not received systemic antitumor therapy; Cohort 2: patients with newly diagnosed resectable stage II-III NSCLC harboring EGFR mutations who have not received systemic antitumor therapy. A total of 79-108 patients are planned to be enrolled in the study, which is divided into a screening period, a treatment period and a follow-up period. During the administration of the study drug, follow-up will be conducted every 6 weeks in the first year and every 12 weeks from the second year onwards.