This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)
Age ≥18 years at the time of ICF signing.
Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).
Confirmed EGFR atypical mutation.
No prior systemic therapy for locally advanced or metastatic NSCLC.
Presence of specific genetic alterations for which approved targeted therapies are available.
Recent participation (within 28 days) in another interventional clinical trial.
Major surgery within 28 days prior to study entry or planned during the study period.
Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy.