squmous cell lung cancer
Conditions
Interventions
Group 1:Afatinib and Docetaxel
Sponsors
Fujian Tumor Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged than 18 ~years old; 2. Histological or cytological diagnosis of squamous lung cancer; 3. patients were diagnosed of stage IV non-small-cell lung cancer (American Joint Committee on Cancer version 8); 4. an Eastern Cooperative Oncology Group performance status of 0 or 1; 5. At least one imaging Computed Tomography (CT) or mri Magnetic Resnane Iamge (MRI) can be measured or assessed. The short diameter of lymph node lesions was more than 15mm, which could be measured without local treatment such as radiotherapy and freezing; 6. patients have a life expectancy of roughly 4 months; 7. First-line treatment was given after stage IV diagnosis, and Docetaxel was not used before; 8. Patients who had been treated with radiation before can be enrolled, but the treatment must be completed at least 4 weeks, and the acute toxic response to previous radiation must be recovered;Local lesions that have been treated with radiation cannot be included in a measurable lesion unless significant progress is noted after the last radiotherapy; 9. adequate organ function defi ned as: absolute neutrophil count greater than 1500 cells per µL; platelet count greater than 75 000 cells per µL; estimated creatinine clearance greater than 45 mL/min; and total bilirubin less than 1/5 times institutional upper limit of normal (ULN); and aspartate aminotransferase or alanine aminotransferase less than three times the institutional ULN; 10. Be able to follow study requirements and follow-up procedures and sign informed consent; 11. Women of childbearing age must use contraceptives (such as intrauterine devices, birth control pills or condoms) during the study period and within 6 months after the study;The blood or urine pregnancy test was negative 7 days before the study, and the patient should be non-lactating. Men were required to use contraceptives during and within 6 months after the study.
Exclusion criteria
Exclusion criteria: 1. Violation of inclusion criteria; 2. Unable to comply with test protocol; 3. It have used Afatinib or Docetaxel in the past; 4. Allergic to Afatinib or Docetaxel; 5. Arteriovenous thrombosis events occurred within 6 months before enrollment: such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 6. Known genetic or acquired bleeding and thrombotic tendencies (e.g., haemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 7. Abnormal coagulation function (INR >1.5 or thrombin time (PT) > ULN+4 seconds or APTT > 1.5uln), with bleeding tendency or being treated with thrombolysis or anticoagulation; 8. A history of interstitial lung disease or a history of interstitial lung disease; 9. It has many factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction after gastrointestinal resection, etc.); 10. Any severe and/or uncontrolled disease exists; 11. mental disturbed; 12. Pregnant or lactating women;A person who is unable or unwilling to take effective contraceptive measures; 13. There are accompanying diseases that seriously affect patient safety or affect patient completion of the study; 14. The investigator identifies other conditions that may affect the conduct of the clinical study and the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactGen Lin
Fujian Tumor Hospital
Outcome results
None listed