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Comparing HER2 test results and readings across labs for Chinese patients with NSCLC, gynecologic, biliary tract, or urothelial cancers

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

Observational AstraZeneca · NCT07404202

This project will test how well different HER2 lab tests and pathologist readings agree for people in China with NSCLC, certain gynecologic cancers, biliary tract cancer, or urothelial cancer using archived tumor samples.

Quick facts

Study typeObservational
Enrollment2100 (estimated)
SexAll
SponsorAstraZeneca Industry-sponsored
Locations14 sites (Beijing and 13 other locations)
Trial IDNCT07404202 on ClinicalTrials.gov

What this trial studies

This multicenter, retrospective, non-interventional effort collected archived tumor samples from about 2,100 Chinese patients with NSCLC, biliary tract cancer, gynecologic cancers (cervical, endometrial, ovarian), or urothelial cancer diagnosed between January 2023 and September 2025. All patients had local HER2 testing (Roche 4B5) and results were reviewed by a three-pathologist committee using governed-concordance algorithms, then 320 patients (80 per tumor type with 20 cases at each IHC level 0/1+/2+/3+) were selected for central comparison. In Part I, central laboratories will run multiple HER2 assays and platforms (Roche 4B5; MXB/Zhongshan/An Biping/Amoy on Ventana or Leica) against HercepTest on the Dako platform and committee pathologist reads to measure assay agreement. In Part II, interpretation concordance across readers and platforms will be quantified to inform diagnostic standardization.

Who should consider this trial

Good fit: Adults (≥18) in China with histologically confirmed NSCLC, biliary tract cancer, cervical/endometrial/ovarian cancers, or urothelial cancer diagnosed between January 1, 2023 and September 30, 2025 who have at least 15 archival tumor slides suitable for HER2 testing are ideal candidates.

Not a fit: Patients without sufficient archived tissue (fewer than 15 slides), with excluded specimen types (for example frozen or decalcified samples), or with a history of other cancers are unlikely to be included or to derive benefit from this project.

Why it matters

Potential benefit: If successful, the results could make HER2 testing more consistent across labs and help patients receive the most appropriate HER2-targeted treatments.

How similar studies have performed: Concordance studies of HER2 testing in breast and gastric cancer have shown variable agreement between assays and readers, so this pan-tumor, multi-assay approach builds on established methods but is comparatively novel for these tumor types.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.)

Where this trial is running

Beijing and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pan-tumorHER2 assay concordance and interpretation concordance
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.