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

NCT00457392

Last updated date
Study Location
Pfizer Investigational Site
Florence, Alabama, 35630, United States
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with locally advanced/metastatic non-small cell lung cancer

- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the
exception of bevacizumab) or other angiogenesis inhibitors


- History of or known brain metastases

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Non-Small Cell Lung CarcinomaA Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
NCT00457392
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  2. Muscle Shoals, Alabama
  3. Scottsdale, Arizona
  4. Hot Springs, Arkansas
  5. Antioch, California
  6. Burbank, California
  7. Downey, California
  8. Fresno, California
  9. La Jolla, California
  10. La Jolla, California
  11. Montebello, California
  12. Pleasant Hill, California
  13. San Diego, California
  14. San Leandro, California
  15. Whittier, California
  16. Fairfield, Connecticut
  17. Brooksville, Florida
  18. Cocoa Beach, Florida
  19. Fort Lauderdale, Florida
  20. Merritt Island, Florida
  21. Rockledge, Florida
  22. Titusville, Florida
  23. Athens, Georgia
  24. Aurora, Illinois
  25. Goshen, Indiana
  26. Indianapolis, Indiana
  27. Council Bluffs, Iowa
  28. Baton Rouge, Louisiana
  29. Lafayette, Louisiana
  30. Bethesda, Maryland
  31. Ann Arbor, Michigan
  32. Troy, Michigan
  33. Columbus, Mississippi
  34. Corinth, Mississippi
  35. Tupelo, Mississippi
  36. St. Louis, Missouri
  37. St. Peters, Missouri
  38. Omaha, Nebraska
  39. Las Vegas, Nevada
  40. Las Vegas, Nevada
  41. Jamaica, New York
  42. Norman, Oklahoma
  43. Oklahoma City, Oklahoma
  44. Oklahoma City, Oklahoma
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  49. Lancaster, Pennsylvania
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  51. Beaumont, Texas
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  55. Bountiful, Utah
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  63. Kennewick, Washington
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  76. Porto Alegre, RS
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  79. Kingston, Ontario
  80. Kingston, Ontario
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  82. Toronto, Ontario
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  85. Levis, Quebec
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  91. Santiago,
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  8. Peoria, Illinois
  9. Hershey, Pennsylvania
  10. West Reading, Pennsylvania
  11. East Providence, Rhode Island
  12. East Providence, Rhode Island
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  16. Sunto-gun, Shizuoka
  17. Lubin,
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  20. Poznan,
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  25. Iasi,
  26. Moscow,
  27. Pyatigorsk,
  28. Saint-Petersburg,
  29. St.Petersburg,
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  32. Madrid,
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  34. Palma de Mallorca,
  35. Sevilla,
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib
Brief Summary This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small Cell Lung
Intervention  ICMJE
  • Drug: erlotinib
    plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
  • Drug: sunitinib
    Sunitinib 37.5 mg daily by oral capsules in a continuous regimen
  • Drug: placebo
    Placebo daily by oral capsules in a continuous regimen
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: erlotinib
    • Drug: sunitinib
  • Active Comparator: 2
    Interventions:
    • Drug: erlotinib
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2011)
960
Original Enrollment  ICMJE
 (submitted: April 4, 2007)
956
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with locally advanced/metastatic non-small cell lung cancer
  • Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria:

  • Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
  • History of or known brain metastases
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00457392
Other Study ID Numbers  ICMJE A6181087
SUN1087
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP