The First Affiliated Hospital of Guangzhou Medical College, Guangzhou,Guangdong Province, China
Jianxing He , Wenhua Liang , Shidong Xu , Shaofa Xu , Jianying Zhou , Weimin Mao , Qun Wang , Xiuyi Zhi , Fenlai Tan , Lieming Ding , Caicun Zhou
Background: Although epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) has been recognized as the standard of care in patients with NSCLC harboring sensitive EGFR mutations in advanced stages, their benefits as adjuvant therapy after resection compared with standard platinum-based chemotherapy remained unclear. There is still not an EGFR-TKI that has been approved in adjuvant setting worldwide. Based on results from ICOGEN (NCT01040780) and a large real-world report (n > 6,000), icotinib (an EGFR-TKI developed in China) has been approved in front-line setting in advanced diseases. This trial is the first study that targeting at expanding the indication of EGFR-TKI to adjuvant setting, with an application for China Food and Drug Administration approval. Methods: This is a phase 3, multicenter, open labeled, and randomized controlled trial. Pathological stage II-IIIA NSCLC patients with sensitive EGFR mutations (deletion in exon 19 and L858R in exon 21) after complete resection were eligible. The primary endpoint is disease-free survival (DFS) and secondary endpoints are overall survival, tolerability and quality of life. The sample size was specified assuming a hazard ratio (HR) of 0.67, equating to an increase in median DFS from an expected 28 months for chemotherapy to 42 months for icotinib. To provide 85% power at a two-sided 5% significance level, and an estimated 10% dropout rate, a total of 320 patients are required. Eligible patients will be 1:1 randomly assigned to receive icotinib or platinum doublets. Experimental arm received icotinib 125 mg tid orally for up to 2 years while the active control arm received intravenously vinorelbine 25 mg/m2, day 1 and day 8 and cisplatin 75 mg/m2 day 1, 21 days/cycle for up to 4 cycles, until disease relapse or intolerable toxicity. Free icotinib will be provided to patients in the control arm upon relapse. Recruitment was started since June 1st, 2015 and is active in 17 out of 31 centers currently. The duration of recruitment will be 61 months (18 months of recruitment and 43 months of follow-up). Clinical trial information: NCT02448797
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