Chinese expert consensus on the diagnosis and treatment of HER2-altered non-small cell lung cancer
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Updated: Aug 19, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Shirong Zhang1, Wenxian Wang2, Chunwei Xu3,4
1Translational Medicine Research Center, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou First People's Hospital, Cancer Center, Zhejiang University School of Medicine, Hangzhou, China.
Abstract:
Human epidermal growth factor receptor 2 (HER2) possesses tyrosine kinase activity and participates in cell growth, differentiation and migration, and survival. Its alterations, mainly including mutations, amplifications, and overexpression are associated with poor prognosis and are one of the major drivers in non-small cell lung cancer (NSCLC). Several clinical trials had been investigating on the treatments of HER2-altered NSCLC, including conventional chemotherapy, programmed death 1 (PD-1) inhibitors, tyrosine kinase inhibitors (TKIs) and antibody-drug conjugates (ADCs), however, the results were either disappointing or encouraging, but inconsistent. Trastuzumab deruxtecan (T-DXd) was recently approved by the Food and Drug Administration as the first targeted agent for treating HER2-mutant NSCLC. Effective screening of patients is the key to the clinical application of HER2-targeted agents such as TKIs and ADCs. Various testing methods are nowadays available, including polymerase chain reaction (PCR), next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), etc. Each method has its pros and cons and should be reasonably assigned to appropriate patients for diagnosis and guiding treatment decisions. To help standardize the clinical workflow, our expert group reached a consensus on the clinical management of HER2-altered NSCLC, focusing on the diagnosis and treatment strategies.
Insights
Human epidermal growth factor receptor 2 (HER2) alterations drive non-small cell lung cancer (NSCLC). This consensus provides guidance on diagnosing and treating HER2-altered NSCLC, optimizing patient selection for targeted therapies.
Area of Science:
- Oncology
- Molecular Biology
- Genetics
Background:
- Human epidermal growth factor receptor 2 (HER2) alterations, including mutations and amplifications, are key drivers in non-small cell lung cancer (NSCLC).
- HER2 alterations are associated with poor prognosis and represent a target for novel therapies.
- Previous treatment strategies for HER2-altered NSCLC yielded inconsistent results.
Purpose of the Study:
- To establish a consensus on the clinical management of HER2-altered NSCLC.
- To provide guidance on diagnostic strategies for identifying HER2 alterations.
- To outline effective treatment approaches for patients with HER2-altered NSCLC.
Main Methods:
- Review of current literature and clinical trial data on HER2-altered NSCLC.
- Expert group consensus development on diagnostic and treatment pathways.
- Evaluation of various diagnostic methods including PCR, NGS, FISH, and IHC.
Main Results:
- Trastuzumab deruxtecan (T-DXd) is approved for HER2-mutant NSCLC, highlighting the importance of targeted therapy.
- Effective patient screening is crucial for the successful application of HER2-targeted agents like TKIs and ADCs.
- Different diagnostic methods have unique advantages and disadvantages, requiring careful selection based on patient needs.
Conclusions:
- Standardized clinical workflows are needed for managing HER2-altered NSCLC.
- Accurate diagnosis and appropriate patient selection are paramount for optimizing treatment outcomes.
- This consensus aims to standardize the clinical workflow for HER2-altered NSCLC diagnosis and treatment.
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