Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (ICOGEN)
2014年1月21日 更新者：Betta Pharmaceuticals Co., Ltd.
A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy
The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.
研究概览
详细说明
Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years .
It is the leading cause of death of cancer in man and 2nd in women.
With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China.
Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician.
It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials.
In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy.
PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.
A total of 400 patients will be recruited.
EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.
研究类型
介入性
注册 (实际的)
399
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100853
- Chinese PLA General Hospital
-
Beijing、Beijing、中国、100020
- Beijing Chao-Yang Hospital
-
Beijing、Beijing、中国、100032
- Peking Union Medical College Hospital
-
Beijing、Beijing、中国、100071
- 307 Hospital of PLA
-
Beijing、Beijing、中国、101149
- Beijing Chest Hospital
-
Beijing、Beijing、中国、100021
- Cancer Hospital, Chinese Academy of Medical Science
-
Beijing、Beijing、中国、100036
- Bejing Cancer Hospital
-
Beijing、Beijing、中国、100079
- Peking University Third Hospital
-
-
Chongqing
-
Chongqing、Chongqing、中国、400042
- Third Affiliated Hospital, Third Military Medical University
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510515
- Nanfang Hospital, Southern Medical University
-
Guangzhou、Guangdong、中国、510080
- Guangdong General Hospital
-
Guangzhou、Guangdong、中国、510000
- Guanghzou General Hospital of PLA
-
Guanzhou、Guangdong、中国、510060
- Sun Yat-Sen Univerisity Cancer Center
-
-
Hunan
-
Changsha、Hunan、中国、410013
- Hunan Cancer Hospital
-
Changsha、Hunan、中国、410011
- The second Xiangya Hospital,Central South University
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210009
- Jiangsu Cancer Hospital
-
Nanjing、Jiangsu、中国、210002
- 81 Hospital of PLA
-
Nanjing、Jiangsu、中国、210002
- Nanjing General Hospital of Nanjing Command，PLA
-
-
Jilin
-
Changchun、Jilin、中国、130012
- Jilin cancer hospital
-
-
Shanghai
-
Shanghai、Shanghai、中国、200433
- Shanghai Pulmonary Hospital
-
Shanghai、Shanghai、中国、200032
- Zhongshan Hospital,Fudan University
-
Shanghai、Shanghai、中国、200433
- Changhai Hospital, Second Military Medical University
-
Shanghai、Shanghai、中国、200023
- Ruijin Hospital，Shanghai Jiao-Tong University
-
-
Shanxi
-
Xi-An、Shanxi、中国、710032
- Xijing hospital, Fourth military medical university
-
Xi-an、Shanxi、中国、710000
- Tangdu Hospital, Fourth Military Medical University
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310022
- Zhejiang Cancer Hospital
-
Hangzhou、Zhejiang、中国、310022
- The First Affiliated Hospital of College of Medicine, Zhejiang University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
- Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.
Exclusion Criteria:
1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：埃克替尼
每天 3 次 125 毫克（每天 375 毫克）口服
|
每天 3 次 125 毫克（每天 375 毫克）口服
其他名称：
|
|
有源比较器：Gefitinib
250 mg every 24 hours by mouth
|
250 mg every 24 hours by mouth
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression Free Survival
大体时间：2-7 months
|
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
|
2-7 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：From first study treatment until time of death
|
Median number of months from first study treatment until time of death
|
From first study treatment until time of death
|
|
Best Tumor Response
大体时间：While receiving study treatment; assessed every 21 days until progression
|
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
|
While receiving study treatment; assessed every 21 days until progression
|
|
Time To Progression
大体时间：2-7 months
|
Median time until disease progression.
Disease progression defined as radiological and/or symptomatic disease progression.
|
2-7 months
|
|
Safety and Tolerability
大体时间：Assessed over two years
|
Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term. Grade 3 = Severe Grade 4 = Life-threatening or disabling |
Assessed over two years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Li Zhang, M.D.、Sun Yat-sen University
- 首席研究员：Yan Sun, M.D.、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- 研究主任：Fenlai Tan, M.D./Ph.D.、Zhejiang Betapharma Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013 Sep;14(10):953-61. doi: 10.1016/S1470-2045(13)70355-3. Epub 2013 Aug 13.
- Camidge DR. Icotinib: kick-starting the Chinese anticancer drug industry. Lancet Oncol. 2013 Sep;14(10):913-4. doi: 10.1016/S1470-2045(13)70385-1. Epub 2013 Aug 13. No abstract available.
- Zhao Q, Shentu J, Xu N, Zhou J, Yang G, Yao Y, Tan F, Liu D, Wang Y, Zhou J. Phase I study of icotinib hydrochloride (BPI-2009H), an oral EGFR tyrosine kinase inhibitor, in patients with advanced NSCLC and other solid tumors. Lung Cancer. 2011 Aug;73(2):195-202. doi: 10.1016/j.lungcan.2010.11.007. Epub 2010 Dec 8.
- Tan F, Shen X, Wang D, Xie G, Zhang X, Ding L, Hu Y, He W, Wang Y, Wang Y. Icotinib (BPI-2009H), a novel EGFR tyrosine kinase inhibitor, displays potent efficacy in preclinical studies. Lung Cancer. 2012 May;76(2):177-82. doi: 10.1016/j.lungcan.2011.10.023. Epub 2011 Nov 22.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年2月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2009年12月27日
首先提交符合 QC 标准的
2009年12月29日
首次发布 (估计)
2009年12月30日
研究记录更新
最后更新发布 (估计)
2014年2月14日
上次提交的符合 QC 标准的更新
2014年1月21日
最后验证
2014年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.