RecruitingPhase 3NCT07183189

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


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

576 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new antibody-drug conjugate called SHR-A2009 combined with aumolertinib (an EGFR-targeted drug) versus aumolertinib alone in people with advanced non-small cell lung cancer whose tumors have EGFR mutations and have not received any prior systemic treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced, metastatic, or recurrent non-small cell lung cancer with confirmed EGFR mutations (in tissue or blood) - You have not previously received systemic treatment for this stage of lung cancer - You have at least one measurable tumor on imaging - Your general health is good (ECOG 0-1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your cancer is confirmed to be small cell lung cancer mixed with NSCLC - You have active brain metastases that are unstable or untreated - You have serious organ function problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSHR-A2009 ; Aumolertinib

SHR-A2009 administered intravenously, Aumolertinib administered orally.

DRUGAumolertinib

Aumolertinib administered orally


Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07183189


Related Trials