An Open-label, Randomized, Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy
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.
• At least one measurable lesion as defined by RECIST v1.1.
• ECOG PS ≤1.
• Life expectancy≥12 weeks.
• Adequate organ function confirmed within 7 days prior to the first dose of study treatment
• 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.
⁃ Non-sterilized males: Abstinence or contraception use; No sperm donation.
⁃ Willing and able to provide signed ICF and to comply with all requirements and restrictions listed in the ICF and this study protocol.