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Non-small Cell Lung CancerPhase 3NCT07183189

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

A Phase 3 study testing SHR-A2009 ; Aumolertinib and Aumolertinib in people with Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
SHR-A2009 ; Aumolertinib and Aumolertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
582 participants
Where
1 siteChina
Study dates
30 Oct 2025to Dec 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: 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 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.

Being tested
SHR-A2009 ; Aumolertinib, Aumolertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A2009 ; AumolertinibDrug

    SHR-A2009 administered intravenously, Aumolertinib administered orally.

  • AumolertinibDrug

    Aumolertinib administered orally

Study groups in NCT07183189
Study groupRoleWhat they receive
investigational treatment group：SHR-A2009 combined with AumolertinibExperimentalNot described
Receives: Drug: SHR-A2009 ; Aumolertinib
control group ：AumolertinibActive comparatorNot described
Receives: Drug: Aumolertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to approximately 38 months

Secondary outcomes (5)

  1. overall survival (OS)

    Measured: Up to approximately 60 months

  2. Progression Free Survival(PFS by investigator)

    Measured: Up to approximately 38months

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

    Measured: Up to approximately 38 months

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

    Measured: Up to approximately 38 months

  5. Incidence of AEs

    Measured: from Day1 to 40 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start30 Oct 2025
  3. Primary completionNov 2032 (estimated)
  4. Study completionDec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
582 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07183189
Sponsor's protocol ID
SHR-A2009-302
Status last verified
Sep 2025
First submitted
12 Sep 2025
Last updated
25 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-A2009 ; Aumolertinib and Aumolertinib in people with Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by BICR according to RECIST v1.1 (time frame: Up to approximately 38 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07183189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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