A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations
This study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.
• Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
• Subjects with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.
• No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
• At least one measurable tumor lesion according to RECIST v1.1.
• ECOG performance status of 0 or 1.
• Expected survival time ≥12 weeks.
• Adequate bone marrow and organ function.
• Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.