SHR-A2009 plus aumolertinib versus aumolertinib for first-line treatment of EGFR-mutated advanced non-small cell lung cancer

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

This trial will test whether adding SHR-A2009 to aumolertinib works better than aumolertinib alone as the first treatment for people with EGFR-mutated advanced or metastatic non-small cell lung cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 576 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: aumolertinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07183189 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled, open-label Phase III trial comparing SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment‑naïve adults with EGFR‑mutated locally advanced or metastatic non‑small cell lung cancer. Eligible participants must have confirmed EGFR mutations, at least one measurable lesion by RECIST v1.1, ECOG performance status 0–1, and adequate organ function. Patients are randomized to receive either the combination regimen or aumolertinib alone, with planned follow-up for efficacy and safety outcomes. The trial is multicenter and sponsored by Suzhou Suncadia Biopharmaceuticals.

Who should consider this trial

Good fit: Adults 18–75 years old with treatment‑naïve, EGFR‑mutated locally advanced or metastatic non‑small cell lung cancer, ECOG 0–1, measurable disease, and adequate organ function are ideal candidates.

Not a fit: Patients who have received prior systemic therapy for advanced disease, have non‑EGFR‑driven tumors, poor performance status, certain excluded histologies, or active leptomeningeal/brainstem/spinal cord metastases are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could improve disease control and potentially extend progression‑free or overall survival compared with aumolertinib alone.

How similar studies have performed: Third‑generation EGFR inhibitors like aumolertinib have shown benefit as first‑line therapy, but combining EGFR TKIs with novel agents remains experimental and results from combination approaches have been mixed.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
2. 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.
3. No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
4. At least one measurable tumor lesion according to RECIST v1.1.
5. ECOG performance status of 0 or 1.
6. Expected survival time ≥12 weeks.
7. Adequate bone marrow and organ function.
8. Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
2. Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
3. Subjects with uncontrolled tumor-related pain, as determined by the investigator.
4. Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
5. Insufficient time interval between prior antitumor therapy and the first dose administration.
6. Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
7. History of other malignancies within ≤5 years prior to the first dose.
8. 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.
9. Severe cardiovascular or cerebrovascular diseases.
10. Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
11. Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
12. Severe infections within 4 weeks prior to the first dose.
13. Subjects with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
14. Active tuberculosis infection.
15. History of immunodeficiency, including positive HIV test.
16. Active hepatitis B or hepatitis C.
17. Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
18. History of severe allergic reactions to aumolertinib or other monoclonal antibodies, or hypersensitivity to any component of SHR-A2009.
19. Known history of alcohol or drug dependence or drug abuse.
20. Psychiatric disorders or poor compliance.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Jun Liu

Conditions Non-small Cell Lung Cancer