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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed
Department of Oncology, Shanghai pulmonary hospital
Shanghai, China
RECRUITINGObjective Response Rate
To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
Time frame: tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months
Progression Free Survival
PFS is evaluated in 24 months since the treatment began
Time frame: 24 months
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