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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

StatusActive, Not Recruiting
PhasePhase 3
Started2025-10-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Enrollment closed, study ongoing
2026-04-09
Study Status v2
Re-verified, no change to tracked fields
2025-12-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10→confirmed 2025-10-30
Study sitesdetails revised at 1 of 1 site
2025-09-12
Original filing
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.
Trial Details
NCT Number NCT07183189
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 582 participants
Start Date 2025-10-30
Primary Completion 2032-11 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-25