Lung cancer
Conditions
Interventions
High dose of Ecotinib group:High dose of Ecotinib
Chemotherapy group:Docetaxel/cisplatin
Sponsors
Chongqing cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.1 Patients volunteered for the study, signed informed consent; 1.2 ECOG PS score was less than or equal to 2 points; 1.3 Expected to survive more than 3 months; 1.4 Patients who were over 18 years old and pathologically proven advanced or metastatic non-small cell lung cancer; 1.5 With at least one evaluation of lesions (refer to RECIST 1.1); 1.6 Patients without chemotherapy or targeted therapy; 1.7 Genetic testing results show that as the sensitive EGFR mutation; 1.8 The main organ within 7 days before the treatment, meet the following criteria: 1) Blood routine standard (No blood transfusion within 14 days); a. Hemoglobin (HB) was 90 g/L or higher; b. Neutrophils absolute value (ANC) acuity 1.5 x 10^9/L; C. The platelet (PLT) = 80 x 10^9/L; 2) Biochemical inspection standard a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or less 2 times the upper limit of normal (ULN), such as with liver metastasis, ALT and AST 5 x ULN or less; b. Total bilirubin (TBIL) was 1.5 x ULN or less; C. Serum creatinine (Cr)was 1.5 x ULN or less or creatinine clearance (CCr) or 60 ml/min; d. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) normal or higher limit (50%). 1.9 Women of child-bearing age should be agreed to in the study during and after 6 months must use birth control (such as intrauterine device, the pill or condoms);In the research into the group of 7 days before the serum or urine pregnancy test negative, and must be non lactating patients; Male patients should be agreed during the study and research within 6 month after using contraception
Exclusion criteria
Exclusion criteria: 2.1 With a variety of factors influencing oral drugs (such as can't swallow, after resection of gastrointestinal tract, chronic diarrhea, etc.); 2.2 Take any other targeted drugs during treatment 2.3 Merge other malignant tumor; 2.4 There are severe and/or failure to control the disease, mainly including: A. Activity or failed to control the serious infection (infection is higher CTC grade AE2) B. Becompensated liver disease, liver cirrhosis, active hepatitis or chronic hepatitis to receive antiviral treatment; C. Have a history of immune deficiency, including other acquired HIV positive or suffering from congenital immunodeficiency disease; D. Poor blood sugar control of diabetes patients (fasting blood glucose (FBG) > 10 tendency/L); E. Poorly controlled hypertension, systolic blood pressure or greater 150 MMHG, diastolic blood pressure 100 MMHG or higher); F. Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (New York heart association (NYHA) classification); G. Renal failure need hemodialysis or peritoneal dialysis; 2.5 Move/vein thrombosis incidents happened in 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism; 2.6 Pregnant patients or patients with nursing; 2.7 Can't understand the experiment content and patients unable to cooperate; 2.8 Refused to sign the informed consent; 2.9 According to the researchers, have serious damage to the patient safety or affect patients completed the research with illness or other special circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective response rate;Disease control rates;Quality of life; | — |
Countries
China
Contacts
Public ContactHuiWen Ma
Chongqing cancer hospital
Outcome results
None listed