Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01040780
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
  Hide 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
No text entered.

Reporting Groups
  Description
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  
NOT COMPLETED     1     3  
Protocol Violation                 1                 3  



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  200     199     399  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     164     159     323  
>=65 years     36     40     76  
Age  
[units: years]
Mean ± Standard Deviation
  55.52  ± 10.14     56.43  ± 9.43     55.98  ± 9.79  
Gender  
[units: participants]
     
Female     82     85     167  
Male     118     114     232  
Region of Enrollment  
[units: participants]
     
China     200     199     399  



  Outcome Measures
  Show All 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
  Hide 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
No text entered.


  More Information
  Hide 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
e-mail: zhangheping@csco.org.cn


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov 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