Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC (IFUM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01203917
First received: September 7, 2010
Last updated: August 13, 2014
Last verified: August 2014
Results First Received: August 5, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Intervention: 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
1060 Caucasian patients with locally advanced or metastatic NSCLC were screened, and 118 patients had activating sensitizing EGFR mutation eligible for the study (EGFR M+). 106 EGFR M+ patients received at least 1 dose of gefitinib. One patient had EGFR mutation not eligible for the study (EGFR M+I) and was started on gefitinib in error.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Applicable

Reporting Groups
  Description
Gefitinib Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.

Participant Flow:   Overall Study
    Gefitinib  
STARTED     107 [1]
COMPLETED     71 [2]
NOT COMPLETED     36  
Death                 29  
Lost to Follow-up                 2  
Withdrawal by Subject                 3  
Due to objective disease progression                 1  
Due to EGFR M+I patient                 1  
[1] 106 patients were EGFR M+ patients and 1 patient was EGFR M+I
[2] Patients on-going study at data cut-off(of which 49 were still on study treatment).



  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.
This is a subset of all the screened patients who are found to be EGFR M+ and who have taken at least one dose of study medication (i.e. EGFR M+ patients are those who have activating sensitising EGFR mutation eligible for the study).

Reporting Groups
  Description
Gefitinib Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.

Baseline Measures
    Gefitinib  
Number of Participants  
[units: participants]
  106  
Age  
[units: Years]
Mean ± Standard Deviation
  64.0  ± 11.81  
Age, Customized  
[units: Participants]
 
> =18 to < 65 Years     52  
> =65 to < 75 Years     28  
> =75 Years     26  
Gender  
[units: Participants]
 
Female     75  
Male     31  
Race/Ethnicity, Customized  
[units: Participants]
 
White     106  
Other     0  



  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR) (Investigator)   [ Time Frame: Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months ]

2.  Secondary:   Disease Control Rate (DCR) (Investigator)   [ Time Frame: Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months ]

3.  Secondary:   Progression - Free Survival (PFS) (Investigator)   [ Time Frame: Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death. ]

5.  Other Pre-specified:   Disease Control Rate (DCR) (Independent Central Review)   [ Time Frame: Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months ]

6.  Other Pre-specified:   Objective Response Rate (ORR) (Independent Central Review))   [ Time Frame: Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months ]

7.  Other Pre-specified:   Progression - Free Survival (PFS) (Independent Central Review)   [ Time Frame: Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Haiyi Jiang
Organization: AstraZeneca
phone: +86 21 60302408
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01203917     History of Changes
Other Study ID Numbers: D791AC00014
Study First Received: September 7, 2010
Results First Received: August 5, 2013
Last Updated: August 13, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Hungary: National Institute of Pharmacy
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Republic of Bulgaria: Bulgarian Drug Agency