A Phase 3 interventional study of SHR-A2009 ; Aumolertinib and Aumolertinib in Non-small Cell Lung Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 582 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.
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Drug: SHR-A2009 ; Aumolertinib
Drug: Aumolertinib
SHR-A2009 administered intravenously, Aumolertinib administered orally.
Aumolertinib administered orally
Progression-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
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Suzhou Suncadia Biopharmaceuticals Co., Ltd.