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Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) (INFORM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00770588
First received: October 9, 2008
Last updated: January 15, 2016
Last verified: August 2012
Results First Received: January 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer (NSCLC)
Interventions: Drug: Gefitinib
Drug: Placebo

  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
A total of 298 patients were screened for the study and 296 subsequently randomized

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
Gefitinib Gefitinib (Iressa® 250 mg) 1 tablet daily
Placebo placebo 1 tablet daily

Participant Flow:   Overall Study
    Gefitinib   Placebo
STARTED   148   148 
COMPLETED   67   53 
NOT COMPLETED   81   95 
Adverse Event                9                2 
Death caused by progression of disease                70                91 
Lost to Follow-up                1                1 
Withdrawal by Subject                1                1 



  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.
No text entered.

Reporting Groups
  Description
Gefitinib Gefitinib (Iressa® 250 mg) 1 tablet daily
Placebo placebo 1 tablet daily
Total Total of all reporting groups

Baseline Measures
   Gefitinib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 148   148   296 
Age, Customized 
[Units: Participants]
     
<45 years   22   22   44 
45-64 years   107   108   215 
65-74 years   18   17   35 
>=75 years   1   1   2 
Gender 
[Units: Participants]
     
Female   65   56   121 
Male   83   92   175 
Smoking status 
[Units: Participants]
     
non-smoker   79   81   160 
ex-smoker   57   55   112 
current smoker   12   12   24 


  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately. ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive. ]

3.  Secondary:   Objective Tumour Response (ORR)   [ Time Frame: TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause. ]

4.  Secondary:   Symptom Improvement   [ Time Frame: at randomization, every 6 weeks until disease progression, and at discontinuation. ]

5.  Secondary:   Adverse Event   [ Time Frame: AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored ]

6.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: 52564555 ext 86 21
e-mail: aztrial_results_posting@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00770588     History of Changes
Obsolete Identifiers: NCT00769639
Other Study ID Numbers: D7913L00071
Study First Received: October 9, 2008
Results First Received: January 17, 2012
Last Updated: January 15, 2016
Health Authority: China: Food and Drug Administration