The ACTIVE study protocol:apatinib or placebo plus gefitinib as first-line treatment for patients with EGFR-mutant advanced non-small cell lung cancer(CTONG1706)

作     者：Zhonghan Zhang Fan Luo Yang Zhang Yuxiang Ma Shaodong Hong Yunpeng Yang Wenfeng Fang Yan Huang Li Zhang Hongyun Zhao 

作者机构：State Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangzhou 510060GuangdongP.R.China Department of Medical OncologySun Yat-sen University Cancer Center651 Dongfeng Road EastGuangzhou 510060GuangdongP.R.China Department of Clinical ResearchSun Yat-sen University Cancer Center651 Dongfeng Road EastGuangzhou 510060GuangdongP.R.China 

出 版 物：《Cancer Communications》 (癌症通讯（英文）)

年 卷 期：2019年第39卷第1期

页      面：607-614页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：This study was funded by the National Key R&D Program of China(Grant Numbers:2016YFC0905500,2016YFC0905503) the 5010 Clinical Research Foundation of Sun Yat-sen University(Grant Number:2016001)and Hengrui Medicine Co.Ltd 

主　　题：NSCLC EGFR VEGFR Tyrosine kinase inhibitors Apatinib Gefitinib Randomized Double-blind Placebo Phase III 

摘      要：Background:Gefitinib,as the first epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI)approved for the treatment of advanced non-small cell lung cancer(NSCLC),has been proved to significantly improve the progression-free survival(PFS)in the first-line setting but suffers from resistance 7-10 months after treatment ***(YN968D1),a potent vascular endothelial growth factor receptor(VEGFR)2-TKI,specifically binds to VEGFR2 and leads to anti-angiogenetic and anti-neoplastic *** inhibition of VEGFR and EGFR path-ways represents a rational approach to improve treatment responses and delay the onset of treatment resistance in EGFR-mutant *** ACTIVE study aims to assess the combination of apatinib and gefitinib as a new treatment approach for EGFR-mutant NSCLC as a first-line ***:This multicenter,randomized,double-blind,placebo-controlled phase III study(NCT02824458)has been designed to assess the efficacy and safety of apatinib or placebo combined with gefitinib as a first-line treatment for patients with EGFR-mutant advanced NSCLC.A total of 310 patients with EGFR-mutation(19del or 21L858R),pathological stage IIIB to IV non-squamous NSCLC were to be *** primary endpoint is investigator assessment of PFS,and the secondary endpoints include independent radiological central(IRC)-confirmed PFS,overall survival(OS),objective response rate(ORR),disease control rate(DCR),time to progressive disease(TTPD),duration of response(DoR),quality of life(QoL)and *** patients are randomized in a 1:1 ratio to receive gefitinib(250 mg,p.o.q.d.)plus apatinib(500 mg,p.o.q.d.)or gefitinib plus placebo,given until disease progression or intolerable adverse *** biomarker analysis will be *** study is being conducted across China and comprises of 30 participating *** commenced in August 2017 and finished in December 2018,most of the patients are in the follow-up ***