A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation

Summary

This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of advanced pre-treated Non-small cell lung cancer With HER2 Mutation. To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe Progression free survival (PFS). To assess the overall survival (OS). A secondary aim is to obtain safety information. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Timeline

Start

2016-10-20

Primary completion

2019-06-20

Completion

2019-06-20

Publications

• Mao S, Yang S, Liu X, Li X, Wang Q, Zhang Y, Chen J, Wang Y, Gao G, Wu F, Jiang T, Zhang J, Yang Y, Lin X, Zhu X, Zhou C, Ren S. Molecular correlation of response to pyrotinib in advanced NSCLC with HER2 mutation: biomarker analysis from two phase II trials. Exp Hematol Oncol. 2023 Jun 9;12(1):53. doi: 10.1186/s40164-023-00417-y.
• Zhou C, Li X, Wang Q, Gao G, Zhang Y, Chen J, Shu Y, Hu Y, Fan Y, Fang J, Chen G, Zhao J, He J, Wu F, Zou J, Zhu X, Lin X. Pyrotinib in HER2-Mutant Advanced Lung Adenocarcinoma After Platinum-Based Chemotherapy: A Multicenter, Open-Label, Single-Arm, Phase II Study. J Clin Oncol. 2020 Aug 20;38(24):2753-2761. doi: 10.1200/JCO.20.00297. Epub 2020 Jul 2.

Drugs

Indications