Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial

Yu-Tao Liu,1 Xue-Zhi Hao,1 De-Ruo Liu,2 Gang Cheng,3 Shu-Cai Zhang,4 Wen-Hua Xiao,5 Yi Hu,6 Jun-Feng Liu,7 Ming He,7 Cui-Min Ding,8 Li Zhang,9 Jun Wang,10 Hui Li,11 Gui-Lan Dong,12 Xiu-Yi Zhi,13 Jian Li,14 Yuan-Kai Shi1 1Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People’s Republic of China; 2Department of General Thoracic Surgery, China-Japan Friendship Hospital, Beijing, People’s Republic of China; 3Department of Medical Oncology, Beijing Hospital, Beijing, People’s Republic of China; 4Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People’s Republic of China; 5Department of Oncology, The First Affiliated Hospital of Chinese PLA General Hospital, Beijing, People’s Republic of China; 6Department of Oncology, Chinese PLA General Hospital, Beijing, People’s Republic of China; 7Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People’s Republic of China; 8Department of Respiratory Medicine, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People’s Republic of China; 9Department of Respiratory Medicine, Peking Union Medical College Hospital, Affiliated to Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People’s Republic of China; 10Department of Thoracic Surgery, Peking University People’s Hospital, Beijing, People’s Republic of China; 11Department of Thoracic Surgery, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, People’s Republic of China; 12Department of Radiotherapy and Chemotherapy, Tangshan People’s Hospital, Tangshan, Hebei, People’s Republic of China; 13Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing, People’s Republic of China; 14Department of Thoracic Surgery, Peking University First Hospital, Beijing, People’s Republic of ChinaCorrespondence: Yuan-Kai ShiDepartment of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, People’s Republic of ChinaTel +86 10 8778 8293Email syuankai@cicams.ac.cnAbstract: The efficacy and possible role of epidermal growth factor receptor tyrosine kinase inhibitors in treating early-stage non-small-cell lung cancer have yet to be established. Therefore, we aimed to explore the efficacy and safety of icotinib in completely resected EGFR-mutant stage II–IIIA lung adenocarcinoma patients who underwent standard chemotherapy. This is a randomised, double-blinded, placebo-controlled, multicentre, Phase III trial. A total of 124 patients aged 18– 75 years who qualified the inclusion criteria were recruited. These patients were randomised (1:1) to receive either icotinib (125 mg 3 times per day) or placebo (the same dosage and frequency) for 36 months, followed by a further 36 months of observational window. The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life. Analyses will be conducted in a full analysis set and a per-protocol set as well. To our knowledge, the present study is the first randomised, double-blinded, placebo-controlled, multicenter trial designed to explore efficacy and safety of icotonib in this population. The results obtained in the near future may provide potential guidance in clinical practice.Trial Registration: This trial was registered on www.ClinicalTrail.gov as NCT02125240.Keywords: EGFR mutation, non-small-cell lung cancer, lung adenocarcinoma, icotinib, adjuvant chemotherapy