• Yuankai Shi, Li Zhang, Xiaoqing Liu, Caicun Zhou, Shucai Zhang, Dong Wang, Qiang Li, Shukui Qin, Chunhong Hu, Yiping Zhang, Jianhua Chen, Ying Cheng, Jifeng Feng, Helong Zhang, Yong Song, Yi-Long Wu, Nong Xu, Jianying Zhou, Rongcheng Luo, Chunxue Bai, Yening Jin, Wenchao Liu, Zhaohui Wei, Fenlai Tan, Yinxiang Wang, Lieming Ding, Hong Dai, Shunchang Jiao, Jie Wang, Li Liang, Weimin Zhang, and Yan Sun.
• Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
• Lancet Oncol.. 2013 Sep 1;14(10):953-61.

BackgroundIcotinib, an oral EGFR tyrosine kinase inhibitor, had shown antitumour activity and favourable toxicity in early-phase clinical trials. We aimed to investigate whether icotinib is non-inferior to gefitinib in patients with non-small-cell lung cancer.MethodsIn this randomised, double-blind, phase 3 non-inferiority trial we enrolled patients with advanced non-small-cell lung cancer from 27 sites in China. Eligible patients were those aged 18-75 years who had not responded to one or more platinum-based chemotherapy regimen. Patients were randomly assigned (1:1), using minimisation methods, to receive icotinib (125 mg, three times per day) or gefitinib (250 mg, once per day) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival, analysed in the full analysis set. We analysed EGFR status if tissue samples were available. All investigators, clinicians, and participants were masked to patient distribution. The non-inferiority margin was 1·14; non-inferiority would be established if the upper limit of the 95% CI for the hazard ratio (HR) of gefitinib versus icotinib was less than this margin. This study is registered with ClinicalTrials.gov, number NCT01040780, and the Chinese Clinical Trial Registry, number ChiCTR-TRC-09000506.Findings400 eligible patients were enrolled between Feb 26, 2009, and Nov 13, 2009; one patient was enrolled by mistake and removed from the study, 200 were assigned to icotinib and 199 to gefitinib. 395 patients were included in the full analysis set (icotinib, n=199; gefitinib, n=196). Icotinib was non-inferior to gefitinib in terms of progression-free survival (HR 0·84, 95% CI 0·67-1·05; median progression-free survival 4·6 months [95% CI 3·5-6·3] vs 3·4 months [2·3-3·8]; p=0·13). The most common adverse events were rash (81 [41%] of 200 patients in the icotinib group vs 98 [49%] of 199 patients in the gefitinib group) and diarrhoea (43 [22%] vs 58 [29%]). Patients given icotinib had less drug-related adverse events than did those given gefitinib (121 [61%] vs 140 [70%]; p=0·046), especially drug-related diarrhoea (37 [19%] vs 55 [28%]; p=0·033).InterpretationIcotinib could be a new treatment option for pretreated patients with advanced non-small-cell lung cancer.Copyright © 2013 Elsevier Ltd. All rights reserved.

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