Status:
RECRUITING
A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 monothe...
Eligibility Criteria
Inclusion
- Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
- Subjects with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.
- 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.
- ECOG performance status of 0 or 1.
- Expected survival time ≥12 weeks.
- Adequate bone marrow and organ function.
- Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.
Exclusion
- Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
- Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
- Subjects with uncontrolled tumor-related pain, as determined by the investigator.
- Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
- Insufficient time interval between prior antitumor therapy and the first dose administration.
- Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
- History of other malignancies within ≤5 years prior to the first dose.
- Subjects with a history of interstitial lung disease, or imaging at screening suggestive of suspected interstitial lung disease; or other moderate to severe pulmonary diseases severely affecting lung function.
- Severe cardiovascular or cerebrovascular diseases.
- Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
- Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
- Severe infections within 4 weeks prior to the first dose.
- Subjects with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
- Active tuberculosis infection.
- History of immunodeficiency, including positive HIV test.
- Active hepatitis B or hepatitis C.
- Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
- History of severe allergic reactions to aumolertinib or other monoclonal antibodies, or hypersensitivity to any component of SHR-A2009.
- Known history of alcohol or drug dependence or drug abuse.
- Psychiatric disorders or poor compliance.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT07183189
Start Date
October 30 2025
End Date
December 1 2032
Last Update
December 18 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080