S-1 Plus Gefitinib Versus Gefitinib Monotherapy in Patients With EGFR-sensitive Mutation Advanced Non-squamous NSCLC

Exclusion Criteria

• •1. Histology confirmed for squamous carcinomas, including mixed gland scale cancer, small cell lung cancer.
• •2. Patients with prior any anti-tumor therapy,including chemotherapy, radiotherapy, immunotherapy or biotherapy
• •3. Patients with prior exposure to EGFR-TKIs or 5-Fu
• •4. Not recovered from previous toxic reactions for anticancer treatment (CTCAE grade 1) or not fully recovered from previous surgery
• •5. Patients who have brain metastasis. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
• •6. Patients haven't been diagnosed other malignant disease, except the basal cell carcinoma and cervical carcinoma.
• •7. A uncontrolled clinical infection, activity, including acute pneumonia,HIV,HCV. , etc.
• •8. Sullivudine, brivudine or other antiviral drugs of similar structure were used within 2 months before randomization
• •9. Patients who have a difficulty in swallowing or drug absorption.
• •10. Patients with a history of interstitial lung disease or with interstitial lung disease;
• •11. There are diseases of alimentary canal such as active duodenal ulcer, the ulcerous colitis, intestinal obstruction or other conditions which can cause gastrointestinal bleeding or perforation in the investigator's opinion; or patient has a history of intestinal perforation, intestinal fistula.
• •12. Evaluation of cardiac function: left ventricular ejection fraction \< 50% (echocardiography); Moderate or above disorders of mitral valve and tricuspid shut down;, serious/unstable angina or acute myocardial infarction coronary artery bypass surgery in 6 months before enrollment; patients with class 2 and above cardiac dysfunction according to New York heart association (NYHA) classification
• •13. Patients with medical history of hemoptysis (defined as about 2.5ml bright blood) 2 weeks before the enrollments
• •14. Stroke and transient ischemic in 12 months before enrollment.
• •15. Severe ulcer in the skin wound, trauma and mucosa or fractures have been not fully healed.
• •16. Patients received CYP3A4 strong inhibitor and/or inducer in 2 weeks before enrollment; Patients received P-gp and breast cancer resistance protein (BCRP) substrates drug in 2 weeks before enrollment.
• •17. Patients has participated in other clinical trials of antitumor drugs within the previous 28 days, except for those who were able to prove that they were using placebo;
• •18. Pregnancy or lactating women or pregnant women may be pregnant before pregnancy test positive;
• •19. Unwillingness to receive contraception by patients or their sexual partners who are fertile but unwilling to receive contraception;
• •20. The investigators think that there is any clinical or laboratory abnormalities in the subjects that are not suitable for this study.
• •21. There is a serious psychological or mental abnormalities, researchers assess subjects to participate in this clinical study compliance is insufficient;
• •22. Allergic reactions to analogs of gefitinib and S-1 and / or Analogs and / or excipients in test drugs.