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New hope for HER2-Mutated lung cancer: phase 3 trial launches

NCT ID NCT06430437

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, SHR-A1811, against standard treatments for people with advanced or metastatic non-small cell lung cancer that has a specific change in the HER2 gene. About 300 participants who have not had prior treatment for advanced disease will be enrolled. The goal is to see if the new drug helps delay cancer growth and improve survival.

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 300 people

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

Started

Jul 2024

Expected to finish

Apr 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. Able and willing to provide a written informed consent 2. 18-75 years old (inclusive of both ends) 3. ECOG score of 0 or 1. 4. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC. 5. Subjects with central laboratory- confirmed functional HER2 mutations 6. No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC. 7. Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1 8. Protocol-defined adequate organ function including cardiac, renal, hepatic function Exclusion Criteria: 1. Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology. 2. Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release. 3. Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis. 4. With poorly controlled tumor-related pain. 5. previous or current with other malignancies. 6. Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia. 7. Subjects with active or previous autoimmune diseases. 8. Subjects with uncontrolled or severe cardiovascular diseases. 9. Subjects with active hepatitis B or hepatitis C.

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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 with HER2- mutations

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

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China