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
1 other identifier
interventional
399
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Feb 2009
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 27, 2009
CompletedFirst Posted
Study publicly available on registry
December 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
May 24, 2012
CompletedFebruary 14, 2014
January 1, 2014
1.1 years
December 27, 2009
February 21, 2012
January 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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 Outcomes (4)
Overall Survival
From first study treatment until time of death
Best Tumor Response
While receiving study treatment; assessed every 21 days until progression
Time To Progression
2-7 months
Safety and Tolerability
Assessed over two years
Study Arms (2)
Icotinib
EXPERIMENTAL125 mg three times daily (375 mg per day) by mouth
Gefitinib
ACTIVE COMPARATOR250 mg every 24 hours by mouth
Interventions
Eligibility Criteria
You may qualify if:
- 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; =.
You may not qualify if:
- \. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020, China
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Bejing Cancer Hospital
Beijing, Beijing Municipality, 100036, China
307 Hospital of PLA
Beijing, Beijing Municipality, 100071, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100079, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149, China
Third Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Guanghzou General Hospital of PLA
Guangzhou, Guangdong, 510000, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital， Southern Medical University
Guangzhou, Guangdong, 510515, China
Sun yat-sen Univerisity Cancer Center
Guanzhou, Guangdong, 510060, China
the Second Xiangya Hospital，Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
81 Hospital of PLA
Nanjing, Jiangsu, 210002, China
Nanjing General Hospital of Nanjing Command，PLA
Nanjing, Jiangsu, 210002, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Ruijin Hospital，Shanghai Jiao-Tong University
Shanghai, Shanghai Municipality, 200023, China
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032, China
Changhai Hospital， Second Military Medical University
Shanghai, Shanghai Municipality, 200433, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Tangdu Hospital, Fourth Military Medical University
Xi’an, Shanxi, 710000, China
Xijing Hospital, Fourth Military Medical University
Xi’an, Shanxi, 710032, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310022, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Related Publications (4)
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.
PMID: 23948350BACKGROUNDZhao 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.
PMID: 21144613BACKGROUNDShi 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.
PMID: 23948351RESULTTan 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.
PMID: 22112293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yan Sun, M.D.
- Organization
- Cancer Hospital, Chinese Academy of Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Sun, M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Li Zhang, M.D.
Sun Yat-sen University
- STUDY DIRECTOR
Fenlai Tan, M.D./Ph.D.
Zhejiang Betapharma Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2009
First Posted
December 30, 2009
Study Start
February 1, 2009
Primary Completion
March 1, 2010
Study Completion
December 1, 2011
Last Updated
February 14, 2014
Results First Posted
May 24, 2012
Record last verified: 2014-01