Actively Recruiting
A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-04-14
576
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive at the time of consent
- Histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer with EGFR mutations confirmed by tissue or blood
- No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of 12 weeks or more
- Adequate bone marrow and organ function
- Provided voluntary written informed consent before trial participation
You will not qualify if you...
- Combined small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components
- History of leptomeningeal, brainstem, or spinal cord metastasis
- Uncontrolled tumor-related pain
- Clinically uncontrolled third-space fluid accumulation
- Insufficient time interval between prior antitumor therapy and first study drug dose
- Major organ surgery or significant trauma within 4 weeks before first study drug dose
- History of other cancers within 5 years before first study drug dose
- History or signs of interstitial lung disease or other severe lung diseases affecting lung function
- Severe cardiovascular or cerebrovascular diseases
- Severe or uncontrolled eye conditions increasing safety risk
- Refractory nausea, vomiting, or chronic gastrointestinal diseases
- Severe infections within 4 weeks before first study drug dose
- Arterial or venous thromboembolic events within 6 months before first study drug dose
- Active tuberculosis infection
- History of immunodeficiency including positive HIV test
- Active hepatitis B or C infection
- Prior allogeneic stem cell or organ transplantation
- Severe allergic reactions to aumolertinib, monoclonal antibodies, or SHR-A2009 components
- History of alcohol or drug dependence or abuse
- Psychiatric disorders or poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
J
Jun Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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