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Active, not recruitingNCT07183189Updated Sep 25, 2026

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

A Phase 3 interventional study of SHR-A2009 ; Aumolertinib and Aumolertinib in Non-small Cell Lung Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment

Updated Sep 25, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
582
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Non-small Cell Lung Cancer
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 582 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
582 participants (actual)

Study arms

  • Experimental
    investigational treatment group:SHR-A2009 combined with Aumolertinib

    Drug: SHR-A2009 ; Aumolertinib

  • Active comparator
    control group :Aumolertinib

    Drug: Aumolertinib

Interventions

  • DrugSHR-A2009 ; Aumolertinib

    SHR-A2009 administered intravenously, Aumolertinib administered orally.

  • DrugAumolertinib

    Aumolertinib administered orally

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What researchers measure

Primary outcomes

  1. Progression-free survival (PFS) assessed by BICR according to RECIST v1.1

    Time frame: Up to approximately 38 months

Secondary outcomes

  1. overall survival (OS)

    Time frame: Up to approximately 60 months

  2. Progression Free Survival(PFS by investigator)

    Time frame: Up to approximately 38months

  3. Duration of response(DoR,by BICR and investigator )

    Time frame: Up to approximately 38 months

  4. Disease control rate(DCR,by BICR and investigator)

    Time frame: Up to approximately 38 months

  5. Incidence of AEs

    Time frame: from Day1 to 40 days after last dose

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Study locations

1 site
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510080, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Sep 25, 2026
Enrollment
576 (estimated)→582 (actual)
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Recruiting→Active, not recruiting
    Enrollment 576 (estimated)→582 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07183189
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Sep 19, 2025
Start date
Oct 30, 2025
Primary completion
Nov 2032 (estimated)
Completion
Dec 2032 (estimated)
Last update
Sep 25, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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