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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040780
Recruitment Status : Completed
First Posted : December 30, 2009
Results First Posted : May 24, 2012
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Interventions: Drug: Icotinib
Drug: Gefitinib

  Participant Flow

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

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 Analyzed 
[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

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

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

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
First Submitted: December 27, 2009
First Posted: December 30, 2009
Results First Submitted: February 21, 2012
Results First Posted: May 24, 2012
Last Update Posted: February 14, 2014