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

Exclusion Criteria

• •1. Previous therapy with other HER2 inhibitors.
• •2. History of severe hypersensitivity reactions to the excipients of the trial drugs.
• •3. Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
• •4. Active brain metastases
• •5. Other malignancy within the past (including primary brain tumor or Leptomeningeal tumor), other than basal cell skin cancer or carcinoma in situ of the cervix
• •6. Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
• •7. Treatment with surgery, chemotherapy, radiotherapy or other target therapy within the past 4 weeks before start of therapy
• •8. Uncontrolled hypertensin,diabetes.
• •9. unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure\>NYHA II, serious cardiac arrhythmia
• •10. Active infection
• •11. Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
• •12. History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• •13. 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.
• •14. Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
• •15. Known history of neurological or psychiatric disease, including epilepsy or dementia.
• •16. Treatment in another clinical trial within the past 4 weeks before start of therapy
• •17. Any of the other conditions of which researchers believe that the patient is not fit to take part in the study.