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New drug cocktail aims to outsmart lung cancer in major trial

NCT ID NCT07183189

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether adding an experimental drug called SHR-A2009 to the standard targeted therapy aumolertinib works better than aumolertinib alone for people with advanced non-small cell lung cancer that has an EGFR mutation. About 576 participants who have not had prior treatment for their advanced cancer will be randomly assigned to one of the two groups. The main goal is to see if the combination delays cancer growth longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-A2009 (an experimental drug) combined with aumolertinib (a targeted therapy pill)
What this could lead to
If successful, this combination could become a new first-line treatment option for people with advanced EGFR-mutant lung cancer, potentially delaying disease progression longer than current standard therapy.
What could go wrong
This is an early-phase 3 trial, so results are not yet known. The combination may cause more side effects than aumolertinib alone, and there is no guarantee it will improve survival or quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 576 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.