A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation
This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation. Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.
• Voluntarily sign the informed consent form (ICF).
• Age ≥18 years at the time of ICF signing.
• At least one measurable lesion per RECIST v1.1, meeting the following:
‣ No prior local therapy (e.g., radiotherapy)
⁃ Not used for biopsy during screening
• Histologically/cytologically confirmed non-squamous NSCLC, classified as:
‣ Locally advanced (Stage IIIB/IIIC, unsuitable for curative surgery and/or definitive chemoradiotherapy)
⁃ Metastatic (Stage IV) (Based on UICC/AJCC 8th edition TNM staging)
• Agreement to provide:
‣ Recent tumor tissue (from untreated lesions)
⁃ Blood samples
⁃ Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.)
• No prior systemic therapy for advanced/metastatic NSCLC.
‣ Allowed if: Prior (neo)adjuvant/definitive chemoradiotherapy completed ≥12 months before recurrence/progression
• ECOG performance status 0-1.
• Life expectancy ≥12 weeks.
• Adequate bone marrow/organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior).
⁃ Women of childbearing potential (WOCBP):
∙ Abstinence or contraception use
‣ No egg donation
⁃ Non-sterilized males:
∙ Abstinence or contraception use
‣ No sperm donation
⁃ CNS metastases allowed if protocol-specified criteria are met.