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A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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.
Official title: A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
576
Start Date
2025-10-30
Completion Date
2032-12
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
SHR-A2009 ; Aumolertinib
SHR-A2009 administered intravenously, Aumolertinib administered orally.
Aumolertinib
Aumolertinib administered orally
Locations (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China