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A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00457392
First received: April 4, 2007
Last updated: September 24, 2013
Last verified: September 2013
Results First Received: July 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small Cell Lung
Interventions: Drug: erlotinib
Drug: sunitinib
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
No text entered.

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
Sunitinib + Erlotinib Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
Erlotinib Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.

Participant Flow:   Overall Study
    Sunitinib + Erlotinib     Erlotinib  
STARTED     480     480  
Treated     473     477  
COMPLETED     0     0  
NOT COMPLETED     480     480  
Objective Progression or Relapse                 229                 296  
Death                 106                 106  
Adverse Event                 84                 41  
Global Deterioration of Health Status                 22                 8  
Withdrawal by Subject                 14                 8  
Lost to Follow-up                 6                 7  
Protocol Violation                 4                 3  
Unspecified                 7                 4  
Study Terminated by Sponsor                 1                 4  
Randomized, Not Treated                 7                 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.
No text entered.

Reporting Groups
  Description
Sunitinib + Erlotinib Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
Erlotinib Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
Total Total of all reporting groups

Baseline Measures
    Sunitinib + Erlotinib     Erlotinib     Total  
Number of Participants  
[units: participants]
  480     480     960  
Age  
[units: Years]
Mean ± Standard Deviation
  61.10  ± 9.97     60.80  ± 9.13     60.90  ± 9.56  
Gender  
[units: Participants]
     
Female     183     196     379  
Male     297     284     581  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline to death or 28 days after last dose for the last participant ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline to disease progression or death due to any cause or 28 days after last dose ]

3.  Secondary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline to disease progression or discontinuation from study or 28 days after last dose ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline to disease progression or death or discontinuation from study or 28 days after last dose ]

5.  Secondary:   One-year Survival Probability   [ Time Frame: Baseline until death or until 28 days after last dose for the last participant ]

6.  Secondary:   EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score   [ Time Frame: Baseline and End of Treatment (EOT) or Withdrawal ]


  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 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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00457392     History of Changes
Other Study ID Numbers: A6181087, SUN1087
Study First Received: April 4, 2007
Results First Received: July 6, 2011
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration