icotinib following chemotherapy versus chemotherapy as adjuvant therapy in stage iia-iiia nsclc with egfr mutation

Conditions: Lung Cancer

Summary: the purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage iia-iiia nsclc harboring egfr mutation.

adjuvant chemotherapy is recommended for routine use in patients with fully resected stage iia-iiia non-small cell lung cancer (nsclc). epidermal growth factor receptor tyrosine kinase inhibitors (egfr-tkis) show great efficacy in patients with advanced non-small cell lung cancer (nsclc) with egfr mutation. icotinib is a novel egfr-tki developed by a group of chinese scientists. in the phase iii icogen trial, icotinib had non-inferiority efficacy to gefitinib with better safety. in phase ii trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage iiia-n2 non-small cell lung cancer harboring egfr mutations. this study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage iia-iiia nsclc harboring egfr mutation.

Eligibility criteria:
inclusion criteria: * written informed consent provided. * aged 18-75 years. * had completely resected pathological confirmed stage iia-iiia nsclc. * egfr activating mutation in exon 19 or 21. * had completed four cycles of platinum-based adjuvant chemotherapy. * able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy. * ecog performance status of 0-1. * had a life expectancy of 12 weeks or more. * adequate hematological function, adequate liver function and renal function. * able to comply with the required protocol and follow-up procedures, and able to receive oral medications. * 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 besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the her axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). * 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.