Clinical Trial

A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-12; most recent amendment 2026-04-09.
Status change: Not Yet Recruiting → Recruiting 2025-12-10
Trial Details
NCT Number NCT07183189
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 576 participants
Start Date 2025-10-30
Primary Completion 2032-11 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-14