the Clinical Trial of Gefitinib(Non - Small Cell Lung Cancer)

Inclusion Criteria:

1. Patients volunteered to participate in this study, signed informed consent;

2. ≥18 years old; ECOG PS score: 0 ~ 1; expected survival period of more than 3 months;

3. patients with locally advanced or metastatic non-small cell lung cancer diagnosed byhistology or cytology, who can not receive radical surgery or radiotherapy; patientswith measurable lesions(according to RECIST criteria);

4. Detection of EGFR-positive exon 19 deletion or exon 21 (L858R) mutation was performedby providing a detectable specimen (tissue or cancerous pleural effusion) prior toenrollment;

5. The main organ function within 7 days before treatment, meet the following criteria:

(1) blood routine examination criteria (14 days without blood transfusion): A) hemoglobin≥ 90g / L; B) neutrophil absolute ≥ 1.5 × 109 / L; C) platelet ≥80 × 109 / L (2) biochemicaltests to meet the following criteria: A) total bilirubin ≤ 1.5 times the upper limit ofnormal (ULN); B) alanine aminotransferase and aspartate aminotransferase AST ≤ 2.5ULN, suchas liver metastasis, ALT and AST ≤ 5ULN; C) serum creatinine ≤ 1.5ULN or creatinineclearance ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejectionfraction (LVEF) ≥ normal low (50%).

6.Women of childbearing age should agree that contraceptive measures (such as intrauterinedevices, birth control pills or condoms) must be used within the study period and within 6months after the end of the study; serum or urine pregnancy test is negative within 7 daysprior to enrollment, And must be non-lactating patients; men should agree to patients whohave contraceptive use during the study period and six months after the end of the studyperiod.

Exclusion Criteria:

1. patients who have previously used EGFR-TKI drugs;

2. small cell lung cancer (including small cell carcinoma and non-small cell carcinomamixed lung cancer);

3. central type, with empty lung squamous cell carcinoma, or with non-small cell lungcancer with hemoptysis (> 50 ml / day) 4.5 years or at the same time with othermalignancies, cured cervical carcinoma in situ, non-melanoma skin cancer andsuperficial bladder tumor except [Ta (non-invasive tumor), Tis (carcinoma in situ )And T1 (tumor infiltrating basement membrane)];

5.Whole-body antitumor therapy was planned within 4 weeks prior to randomization or duringthe course of this study, including cytotoxic therapy, signal transduction inhibitors,immunotherapy (or use of mitogen at 6 weeks prior to administration of the test drug) C); 6.patients with symptomatic or unstable brain metastases; 7.patients with any severe and /or uncontrolled disease, including: A) cirrhosis, acute or active hepatitis; B) history ofimmunodeficiency, including HIV-positive or other acquired, congenital immunodeficiencydisease, or history of organ transplantation; C) patients with seizures and who needtreatment; 8.active or uncontrollable serious infection (≥CTC AE Level 2 infection); 9.witha history of mental illness and can not quit or have mental disorders; 10.participated inother anti-tumor drug clinical trials within four weeks; 11.According to the judge'sjudgment, there is an impact on the absorption of oral drugs or serious harm to the safetyof patients is not suitable for participation in the study of the situation.