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, Xue-Zhi Hao, De-Ruo Liu, Gang Cheng, Shu-Cai Zhang, Wen-Hua Xiao, Yi Hu, Jun-Feng Liu, Ming He, Cui-Min Ding, Li Zhang, Jun Wang, Hui Li, Gui-Lan Dong, Xiu-Yi Zhi, Jian Li, Yuan-Kai Shi, Yu-Tao Liu, Xue-Zhi Hao, De-Ruo Liu, Gang Cheng, Shu-Cai Zhang, Wen-Hua Xiao, Yi Hu, Jun-Feng Liu, Ming He, Cui-Min Ding, Li Zhang, Jun Wang, Hui Li, Gui-Lan Dong, Xiu-Yi Zhi, Jian Li, Yuan-Kai Shi

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; adjuvant chemotherapy; icotinib; lung adenocarcinoma; non-small-cell lung cancer.

Conflict of interest statement

The authors declare that they have no conflict of interest.

© 2020 Liu et al.

Figures

Figure 1
Figure 1
Study flow-chart. Abbreviations: ECG, electrocardiography. AE, adverse event. FACT-L, Functional Assessment of Cancer Therapy-Lung.

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