NCT07183189

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SHR-A2009 ; Aumolertinib	SHR-A2009 administered intravenously, Aumolertinib administered orally.
DRUG	Aumolertinib	Aumolertinib administered orally

Timeline

• Start date: 2025-10-30
• Primary completion: 2032-11-01
• Completion: 2032-12-01
• First posted: 2025-09-19
• Last updated: 2026-04-14

Locations

1 site across 1 country: China