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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
HR-BLTN-II-NSCLC Investigational Site
Beijing, China
HR-BLTN-II-NSCLC Investigational Site
Changsha, China
Objective Response Rate (ORR)
Time frame: tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months
Progression Free Survival (PFS)
Time frame: up to 24 months
Incidence and Intensity of Adverse Events
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Time frame: From signing informed consent document until 28 days after the last drug administration
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HR-BLTN-II-NSCLC Investigational Site
Guangzhou, China
HR-BLTN-II-NSCLC Investigational Site
Hangzhou, China
HR-BLTN-II-NSCLC Investigational Site
Harbin, China
HR-BLTN-II-NSCLC Investigational Site
Nanjing, China
HR-BLTN-II-NSCLC Investigational Site
Shanghai, China
HR-BLTN-II-NSCLC Investigational Site
Suzhou, China
HR-BLTN-II-NSCLC Investigational Site
Wuhan, China
...and 1 more locations