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- December 27, 2009, Clinicaltrials.gov (US NIH). Safety and efficacy study of icotinib in non-small cell lung cancer (NSCLC) patients (ICOGEN) is ongoing. The purpose of this study is to determine whether Icotinib is at least non-inferior to gefitinib in the treatment of advanced NSCLC patients after one or two chemotherapies. Study is designed as a randomized, double-blind, multicenter phase III trial with oral administration. Study endpoint classification: safety/ efficacy.
- September 21, 2009, Chinese Clinical Trial Registry (chictr.org). Public title: a randomized, double-Blind, double dummy, multicenter phase II/III trial to evaluate the safety and efficacy of icotinib and gefitinib in advanced NSCLC patients previously treated with chemotherapy. Target sample size Total: 400 Group A: 200 Group B: 200Primary outcomes: Progression-Free Survival (PFS). Secondary outcomes: OS, ORR, DCR, QoL and safety.
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