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.
Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
Subjects with uncontrolled tumor-related pain, as determined by the investigator.
Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
Parallel
SHR-A2009 ; Aumolertinib
DrugSHR-A2009 administered intravenously, Aumolertinib administered orally.
Aumolertinib
DrugAumolertinib administered orally
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
overall survival (OS)
Progression Free Survival(PFS by investigator)
Duration of response(DoR，by BICR and investigator )
Disease control rate（DCR，by BICR and investigator）
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