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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Aged ≥18 and ≤80 years.
ECOG performance status of 0 to 1.
Life expectancy of more than 12 weeks.
At least one measurable lesion exists.(RECIST 1.1)
Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
Required laboratory values including following parameters:
ANC: ≥ 1.5 x 10\^9/L, Platelet count: ≥ 80 x 10\^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: \< 470 ms
Signed informed consent.
You may not be if
Subjects with third space fluid that can not be controled by drainage or other methods.
Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
Receiving any other antitumor therapy.
Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
Known history of neurological or psychiatric disease, including epilepsy or dementia.
