Study to Compare HER2 Testing Accuracy in Chinese Patients with Various Solid Tumors Including NSCLC, Gynecological, Biliary Tract, and Urothelial Cancers

What this Trial Is About

Researchers are conducting a multicenter, non-interventional, descriptive study to collect and analyze solid tumor samples from patients with non-small cell lung cancer NSCLC, biliary tract cancer BTC, gynecological cancers GYN, and urothelial carcinoma UC. The study aims to assess the agreement between different HER2 immunohistochemistry IHC assays and the interpretation consistency among pathologists. This study involves about 2100 patients diagnosed between January 2023 and September 2025 from 12 sites. The study has two phases enrollment and assessment. During enrollment, approximately 2100 patients are retrospectively collected and tested for HER2 status using the Roche 4B5 assay at local labs. A committee reviews and aligns these results. In the assessment phase, 320 patients are selected based on HER2 expression levels to evaluate assay performance and interpretation concordance. Tissue samples are sectioned into at least 15 slides for various assays, including Roche 4B5 and HercepTest, with results reviewed by pathologists. Digitalized slides are interpreted by 36 trained pathologists to evaluate inter-observer agreement. Participants archived tumor tissues are analyzed with multiple assays, and interpretation results are compared to assess agreement. The study measures include positive and negative percent agreement of HER2 IHC assays and inter-observer concordance across different HER2 expression levels. The assessment phase and interpretation evaluations last up to approximately six months. This study does not involve treatment but focuses on comparing testing methods and interpretation consistency for HER2 status in these cancers.

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