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

Authors Liu YT, Hao XZ, Liu DR, Cheng G, Zhang SC, Xiao WH, Hu Y, Liu JF, He M, Ding CM, Zhang L, Wang J, Li H, Dong GL, Zhi XY, Li J, Shi YK

Received 27 November 2019

Accepted for publication 21 April 2020

Published 17 June 2020 Volume 2020:12 Pages 4633—4643

DOI https://doi.org/10.2147/CMAR.S240275

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Eileen O'Reilly


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 China

Correspondence: Yuan-Kai Shi
Department 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 China
Tel +86 10 8778 8293
Email syuankai@cicams.ac.cn

Abstract: 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

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