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

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NCT07404202 · readout in 134 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Status
Recruiting
Study type
Observational
Enrollment
2,100estimated
Sites
14
Country
China

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2026-03-06actualWhen the study began enrolling
Primary completion2026-12-31estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-12-31estimatedThe whole study's end, after follow-up
First posted2026-02-11actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-11actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Pan-tumor(NSCLC, GYN Cancers, BTC and UC)

Primary outcomes

what the primary-completion date above is the date OF
NPA of HER2 IHC 3+ based on confusion matrix results betwee other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest
measured 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
measured From the assessment phase start to the final slides interpreted,up to approximately 6 month

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