Cancer Communications
indexed by SCI
BMC

Study Protocol
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)
Zhonghan Zhang, Fan Luo, Yang Zhang, Yuxiang Ma, Shaodong Hong, Yunpeng Yang, Wenfeng Fang, Yan Huang, Li Zhang & Hongyun Zhao
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine; Department of Clinical Research, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, P. R. China
[Abstract]

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?C10 months after treatment initiation. Apatinib (YN968D1), a potent vascular endothelial growth factor receptor (VEGFR) 2-TKI, specifically binds to VEGFR2 and leads to anti-angiogenetic and anti-neoplastic effect. Concurrent inhibition of VEGFR and EGFR pathways represents a rational approach to improve treatment responses and delay the onset of treatment resistance in EGFR-mutant NSCLC. This ACTIVE study aims to assess the combination of apatinib and gefitinib as a new treatment approach for EGFR-mutant NSCLC as a first-line setting.
Methods
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 enrolled. The 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 safety. The 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 events. Exploratory biomarker analysis will be performed. This study is being conducted across China and comprises of 30 participating centers. Enrollment commenced in August 2017 and finished in December 2018, most of the patients are in the follow-up period.
Anticipated outcomes and significance
The present study will be the first to evaluate the efficacy and safety profile of the combination of apatinib plus gefitinib as a first-line therapy for patients with EGFR-positive advanced non-squamous NSCLC. Importantly, this trial will provide comprehensive evidence on the treatment of EGFR-TKIs combined with antiangiogenic therapy.
Cancer Communications   Epub date: 11/7/2019   doi:10.1186/s40880-019-0414-4
[PDF Full-text]

[ Html full-text] (BioMed Central)

[ PubMed]

Cite this article

Zhonghan Zhang, Fan Luo, Yang Zhang, Yuxiang Ma, Shaodong Hong, Yunpeng Yang, Wenfeng Fang, Yan Huang, Li Zhang & Hongyun Zhao. 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). Cancer Commun (Lond). 2019, 39:69. doi:10.1186/s40880-019-0414-4


Export citations

EndNote

CJC Wechat 微信公众号


 

Editorial Manager


CC adopts ScholarOne Manuscripts to manage its submissions from Nov.1, 2019

 Submission Guidelines  

 

Reference style for  

 EndNote,
 Reference Manager



Editorial Manager


 

Year:

 

Month:

Advanced search

Subscription


CC is now published by BioMed Central

© Cancer Communications

651 Dongfeng Road East, Guangzhou 510060, P. R. China