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Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (ICOGEN)

This study has been completed.
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd. Identifier:
First received: December 27, 2009
Last updated: January 21, 2014
Last verified: January 2014
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Interventions: Drug: Icotinib
Drug: Gefitinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled between 26 Febrary 2009 and 13 November 2010 across 27 study sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Icotinib Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib Gefitinib 250 mg every 24 hours by mouth

Participant Flow:   Overall Study
    Icotinib   Gefitinib
STARTED   200   199 
COMPLETED   199   196 
Protocol Violation                1                3 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Icotinib Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib Gefitinib 250 mg every 24 hours by mouth
Total Total of all reporting groups

Baseline Measures
    Icotinib   Gefitinib   Total
Overall Participants 
[units: participants]
 200   199   399 
[units: participants]
<=18 years   0   0   0 
Between 18 and 65 years   164   159   323 
>=65 years   36   40   76 
[units: years]
Mean (Standard Deviation)
 55.52  (10.14)   56.43  (9.43)   55.98  (9.79) 
[units: participants]
Female   82   85   167 
Male   118   114   232 
Region of Enrollment 
[units: participants]
China   200   199   399 

  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: 2-7 months ]

2.  Secondary:   Overall Survival   [ Time Frame: From first study treatment until time of death ]

3.  Secondary:   Best Tumor Response   [ Time Frame: While receiving study treatment; assessed every 21 days until progression ]

4.  Secondary:   Time To Progression   [ Time Frame: 2-7 months ]

5.  Secondary:   Safety and Tolerability   [ Time Frame: Assessed over two years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Yan Sun, M.D.
Organization: Cancer Hospital, Chinese Academy of Medical Sciences
phone: 0086-010-87788519

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Betta Pharmaceuticals Co.,Ltd. Identifier: NCT01040780     History of Changes
Other Study ID Numbers: BPI-2009
Study First Received: December 27, 2009
Results First Received: February 21, 2012
Last Updated: January 21, 2014
Health Authority: China: Food and Drug Administration