Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations
Trial Parameters
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years at the time of ICF signing. 2. Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC). 3. Confirmed EGFR atypical mutation. 4. No prior systemic therapy for locally advanced or metastatic NSCLC. 5. At least one measurable lesion as defined by RECIST v1.1. 6. ECOG PS ≤1. 7. Life expectancy≥12 weeks. 8. Adequate organ function confirmed within 7 days prior to the first dose of study treatment 9. Female participants must use adequate contraceptive measures during study participation and for 90 days after the last dose of study treatment and must not be breastfeeding; female subjects not of childbearing potential must meet at least one of the following criteria at screening: Postmenopausal status; Documentation of irreversible surgical sterilization. 10. Non-sterilized males: Abstinence or contraception use; No sperm donation. 11. Willing and