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HER2 test showdown: which lab method is best for chinese cancer patients?

NCT ID NCT07404202

Knowledge-focused Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 4 times

Summary

This study looks at tumor samples from 2,100 Chinese patients with lung, gynecologic, bile duct, or bladder cancers. Researchers will compare different HER2 testing methods to see how well they agree with each other. The goal is to improve the accuracy of HER2 testing, which helps guide treatment decisions.

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.

Participants

About 2,100 people

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

Started

Mar 2026

Expected to finish

Dec 2026

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.

Who is studied

Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Patients must be at least 18 years of age 2. Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025. * For GYN cancers, only cervical cancer, endometrial cancer and ovarian cancer should be included. For each gynecological cancer listed above, at least 5 cases need to be enrolled at each expression level (i.e., IHC 0/1+/2+/3+). 3. Patients must have sufficient archived tumor tissue available, with at least 15 slides suitable for HER2 status determination. Both resection or biopsy samples are acceptable. The age limit of archived tissue blocks is 5 years. Exclusion Criteria: 1. Have a history of other cancers besides NSCLC, BTC, GYN cancers and UC. 2. Specimens of patients that may affect interpretation evaluated by the researcher (e.g., frozen specimens, decalcified specimens, specimens with limited tumor content, etc.)

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Conditions

The condition(s) this trial relates to.

biliary tract cancer cervical cancer endometrial cancer non-small cell lung carcinoma ovarian cancer urothelial carcinoma

As listed by the trial registrant

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

Pan-tumor(NSCLC, gyn cancers, BTC and uc)

How to take part

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

  1. The places running it

    10 sites. 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

  • Research Site

    RECRUITING

    Beijing, China

  • Research Site

    WITHDRAWN

    Changsha, China

  • Research Site

    RECRUITING

    Chengdu, China

  • Research Site

    RECRUITING

    Guangzhou, China

  • Research Site

    WITHDRAWN

    Guangzhou, China

  • Research Site

    RECRUITING

    Haerbin, China

  • Research Site

    RECRUITING

    Jinan, China

  • Research Site

    RECRUITING

    Nantong, China

  • Research Site

    WITHDRAWN

    Shanghai, China

  • Research Site

    RECRUITING

    Shanghai, China

  • Research Site

    RECRUITING

    Shenyang, China

  • Research Site

    WITHDRAWN

    Suzhou, China

  • Research Site

    RECRUITING

    Ürümqi, China

  • Research Site

    RECRUITING

    Zhejiang, China

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