A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients (Pan HER2)

May 19, 2026 updated by: AstraZeneca

Pan HER2: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients

This is a multicenter, non-interventional, descriptive study to retrospectively collect solid tumor samples from focused tumor types (NSCLC, GYN cancers, BTC and UC) and assess both assay concordance and interpretation concordance.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a multicenter, non-interventional, descriptive study which included about 2100 patients, a mixture of NSCLC, BTC, GYN cancers and UC, from 12 sites with confirmed diagnosis between 2023 Jan and 2025 Sep. This study includes two phases, which are enrollment phase and assessment phase.

In the enrollment phase, all sites will retrospectively collect about 2100 patients (NSCLC ~1,000; BTC ~500; GYN ~450; and UC ~150). Every patient will be tested for HER2 status by 4B5 in local labs. All HER2 results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Based on HER2 results by HercepTest at central lab, patient will be selected for further evaluation in assessment phase.

In assessment phase, a total of 320 patients will be included and selected from enrollment phase to meet sample size requirement which is 80 patients with different HER2 expression level (each 20 cases for IHC 0/1+/2+/3+) in NSCLC, BTC, GYN cancers and UC cohorts.

In Part I Assay performance evaluation, tissue sample of every patient will be sectioned at least 15 slides and send to central labs for assays evaluation. Interpretation results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Assays and performed platform details are listed below: Roche 4B5 in Ventana platform, MXB\Zhongshan\An Biping\Amoy in Ventana (or Leica) platform (5 assays) v.s. HercepTest in Dako platform.

Part II Interpretation concordance evaluation: inter-obsever agreement will be evaluated based on scanned images. Specifically, the first 40 slides (each 10 for 0/1+/2+/3+, each 10 for four disease cohorts) will be selected and digitalized. 36 pathologists, 3 from each site, will be trained for GC interpretation algorithm before joining in the assessment. All slides will be interpreted by all pathologists.

Study Type

Observational

Enrollment (Estimated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Research Site
      • Changsha, China
        • Withdrawn
        • Research Site
      • Chengdu, China
        • Recruiting
        • Research Site
      • Guangzhou, China
        • Recruiting
        • Research Site
      • Guangzhou, China
        • Not yet recruiting
        • Research Site
      • Guangzhou, China
        • Withdrawn
        • Research Site
      • Haerbin, China
        • Recruiting
        • Research Site
      • Jinan, China
        • Recruiting
        • Research Site
      • Nantong, China
        • Recruiting
        • Research Site
      • Shanghai, China
        • Recruiting
        • Research Site
      • Shanghai, China
        • Withdrawn
        • Research Site
      • Shenyang, China
        • Not yet recruiting
        • Research Site
      • Suzhou, China
        • Withdrawn
        • Research Site
      • Zhejiang, China
        • Not yet recruiting
        • Research Site
      • Ürümqi, China
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NSCLC
Approximately 1,000 non-small cell lung cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.
BTC
Approximately 500 biliary tract cancer samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.
GYN
Approximately 450 gynecological cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.
UC
Approximately 150 urothelial carcinoma samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPA of HER2 IHC 3+ based on confusion matrix results betwee other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the NPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the PPA of HER2 IHC 3+ based on confusion matrix results between other assays (Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
From the assessment phase start to the final slides interpreted，up to approximately 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-observer concordance in binary HER2 negative (IHC 0/1+/2+) and positive status (IHC3+);
Time Frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
To assess the Inter-observer concordance in binary HER2 negative (IHC 0/1+/2+) and positive status (IHC3+);
From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
Inter-observer concordance in binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+);
Time Frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
To assess the Inter-observer concordance in binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+);
From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
Inter-observer concordance in four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0
Time Frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
To assess the Inter-observer concordance in four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0
From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month
OPA of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the OPA of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the Cohen's kappa of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest
From the assessment phase start to the final slides interpreted，up to approximately 6 month
NPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the NPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the PPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month
OPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the OPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the Cohen's kappa of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month
NPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the NPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month
PPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the PPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month
OPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the OPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month
Cohen's kappa of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
Time Frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month
To assess the Cohen's kappa of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort
From the assessment phase start to the final slides interpreted，up to approximately 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D9673L00020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes,indicates that AZ are accepting requests for IPD,but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitment at made to the EFPIA Pharma Data Sharing Principles .For details of our timeline please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment vivli.org. Signed Data Usage Agreement(non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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