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

NCT07183189 Phase 3 RECRUITING

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.

Details

Lead sponsor	Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	576
Start date	2025-10-30
Completion	2032-12

Conditions

• Non-small Cell Lung Cancer

Interventions

• SHR-A2009 ; Aumolertinib
• Aumolertinib

Primary outcomes

• Progression-free survival (PFS) assessed by BICR according to RECIST v1.1 — Up to approximately 38 months

Countries

China