Non-small Cell Lung Cancer Clinical Trial
Official title:
Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Pyrotinib as a Single Agent in HER2 Mutation Advanced Non-small Cell Lung Cancer Patients Who Failed to Previous at Least 2nd Line Treatments
Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with
HER2 positive advanced pre-treated Non-small cell lung cancer.
To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe
Progression free survival （PFS）. To assess the overall survival (OS). To assess side
effects. To evaluate quality of life. To explore the relationship between biomarkers and the
toxicity/efficacy of Pyrotinib.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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