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New hope for EGFR lung cancer: experimental drug SHR-A2009 takes on chemo in phase 3 trial

NCT ID NCT06671379

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study compares a new experimental drug, SHR-A2009, to standard chemotherapy in 498 people with advanced EGFR-mutated non-small cell lung cancer whose current targeted therapy (EGFR TKI) has stopped working. The goal is to see if SHR-A2009 can better control the cancer and extend life. Participants receive either SHR-A2009 or a chemo combination (pemetrexed plus carboplatin or cisplatin) by IV.

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 given by IV)
What this could lead to
If it works, this could offer a new treatment option for people with EGFR-mutant lung cancer whose current targeted therapy has stopped working.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not work better than chemo, and side effects are unknown. Results may not apply to all patients.

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

498 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Jun 2027

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 old (inclusive), Female or male 2. Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology 3. Previously treated by EGFR-TKI； 4. At least one measurable tumor lesion according to RECIST v1.1 5. ECOG performance score of 0-1; 6. Expected survival time ≥ 12 weeks; 7. Adequate bone marrow and organ function 8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Subjects with active central nervous system (CNS) metastases. 2. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug; 3. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug; 4. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug; 5. Concomitant other malignancies ≤ 5 years prior to first dose of study drug; 6. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function 7. Serious cardiovascular disease 8. Presence of severe infection within 4 weeks prior to first dose of study drug 9. Arterial/venous thrombotic events within 3 months prior to the first study dose 10. History of immunodeficiency, including a positive HIV test 11. Presence of active hepatitis B or C; 12. History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer

Contacts and locations

Locations

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

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