- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040780
Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (ICOGEN)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100853
- Chinese PLA General Hospital
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Beijing, Beijing, China, 100020
- Beijing Chao-Yang Hospital
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Beijing, Beijing, China, 100032
- Peking Union Medical College Hospital
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Beijing, Beijing, China, 100071
- 307 Hospital of PLA
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Beijing, Beijing, China, 101149
- Beijing Chest Hospital
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Beijing, Beijing, China, 100021
- Cancer Hospital, Chinese Academy of Medical Science
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Beijing, Beijing, China, 100036
- Bejing Cancer Hospital
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Beijing, Beijing, China, 100079
- Peking University Third Hospital
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Chongqing
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Chongqing, Chongqing, China, 400042
- Third Affiliated Hospital, Third Military Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, China, 510080
- Guangdong General Hospital
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Guangzhou, Guangdong, China, 510000
- Guanghzou General Hospital of PLA
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Guanzhou, Guangdong, China, 510060
- Sun Yat-Sen Univerisity Cancer Center
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Hunan
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Changsha, Hunan, China, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, China, 410011
- The second Xiangya Hospital,Central South University
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Jiangsu Cancer Hospital
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Nanjing, Jiangsu, China, 210002
- 81 Hospital of PLA
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Nanjing, Jiangsu, China, 210002
- Nanjing General Hospital of Nanjing Command,PLA
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Jilin
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Changchun, Jilin, China, 130012
- Jilin Cancer Hospital
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Shanghai
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Shanghai, Shanghai, China, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Shanghai, China, 200032
- Zhongshan Hospital,Fudan University
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Shanghai, Shanghai, China, 200433
- Changhai Hospital, Second Military Medical University
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Shanghai, Shanghai, China, 200023
- Ruijin Hospital,Shanghai Jiao-Tong University
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Shanxi
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Xi-An, Shanxi, China, 710032
- Xijing Hospital, Fourth Military Medical University
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Xi-an, Shanxi, China, 710000
- Tangdu Hospital, Fourth Military Medical University
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, China, 310022
- The First Affiliated Hospital of College of Medicine, Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Icotinib
125 mg three times daily (375 mg per day) by mouth
|
125 mg three times daily (375 mg per day) by mouth
Other Names:
|
Active Comparator: Gefitinib
250 mg every 24 hours by mouth
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250 mg every 24 hours by mouth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From first study treatment until time of death
|
Median number of months from first study treatment until time of death
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From first study treatment until time of death
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Best Tumor Response
Time Frame: While receiving study treatment; assessed every 21 days until progression
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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
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While receiving study treatment; assessed every 21 days until progression
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Time To Progression
Time Frame: 2-7 months
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Median time until disease progression.
Disease progression defined as radiological and/or symptomatic disease progression.
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2-7 months
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Safety and Tolerability
Time Frame: Assessed over two years
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Li Zhang, M.D., Sun Yat-sen University
- Principal Investigator: Yan Sun, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study Director: Fenlai Tan, M.D./Ph.D., Zhejiang Betapharma Inc.
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Gefitinib
Other Study ID Numbers
- BPI-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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