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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
576
SHR-A2009 administered intravenously, Aumolertinib administered orally.
Aumolertinib administered orally
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS) assessed by BICR according to RECIST v1.1
Time frame: Up to approximately 38 months
overall survival (OS)
Time frame: Up to approximately 60 months
Progression Free Survival(PFS by investigator)
Time frame: Up to approximately 38months
Duration of response(DoR,by BICR and investigator )
Time frame: Up to approximately 38 months
Disease control rate(DCR,by BICR and investigator)
Time frame: Up to approximately 38 months
Incidence of AEs
Time frame: from Day1 to 40 days after last dose
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