This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
498
SHR-A2009 monotherapy ,SHR-A2009 will be administered intravenously
Pemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent,all drugs will be administered intravenously
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
Time frame: Up to approximately 32 months
overall survival (OS)
Time frame: Up to approximately 32 months
Progression Free Survival(PFS by investigator)
Time frame: Up to approximately 32 months
Duration of response(DoR,by BICR and investigator )
Time frame: Up to approximately 32 months
Disease control rate(DCR,by BICR and investigator)
Time frame: Up to approximately 32 months
Incidence of AEs
Time frame: from Day1 to 40 days after last dose
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