Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Inclusion Criteria

• Written informed consent provided.
• Males or females, Aged 18-75 years.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
• EGFR activating mutation in exon 19 or 21.
• Patient who can start the investigational therapy within 3-6 weeks after the complete resection.
• ECOG performance status of 0-1.
• Had a life expectancy of 12 weeks or more.
• Adequate hematological function, adequate liver function and renal function.
• Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

Exclusion Criteria

• Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• Inability to comply with protocol or study procedures.
• Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
• Any evidence confirmed tumor recurrence before investigational therapy.
• Known severe hypersensitivity to icotinib or any of the excipients of this product.
• Evidence of clinically active interstitial lung disease.
• Eye inflammation not fully controlled or conditions predisposing the subject to this.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Known human immunodeficiency virus (HIV) infection.
• Pregnancy or breast-feeding women.
• Ingredients mixed with small cell lung cancer patients.
• History of neurologic or psychiatric disorders.