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RECRUITING
NCT07183189
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

SHR-A2009 ; Aumolertinib

SHR-A2009 administered intravenously, Aumolertinib administered orally.

DRUG

Aumolertinib

Aumolertinib administered orally

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China