A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender. 2. 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. 3. No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer. 4. At least one measurable tumor lesion according to RECIST v1.1. 5. ECOG performance status of 0 or 1. 6. Expected survival time ≥12 weeks. 7. Adequate bone marrow and organ function. 8. Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components. 2. Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.