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

Recruiting now · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07183189

Run by

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

People needed

576

Starts

2025-10-30

Expected to finish

2032-12-01

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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