A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
Pan HER2: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
- Pan-tumor(NSCLC, GYN Cancers, BTC and UC)
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- AstraZeneca
- Enrolment target
- 2,100
- Started
- 6 March 2026
- Main results due
- 31 December 2026
- Study sites
- 14
- Registry updated
- 24 September 2026
Can you take part?
- No age limit is stated.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.)
What this study is about
In the sponsor’s own words, from the registry.
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 sites(14)
Research Site
Beijing, China
Recruiting
Research Site
Changsha, China
Withdrawn
Research Site
Chengdu, China
Recruiting
Research Site
Guangzhou, China
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Withdrawn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
Withdrawn
Research Site
Shanghai, China
Recruiting
Research Site
Shenyang, China
Recruiting
Research Site
Suzhou, China
Withdrawn
Research Site
Ürümqi, China
Recruiting
Research Site
Zhejiang, China
Recruiting
Showing 14 of 14 sites. 10 of the 14 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07404202. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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