A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

NCT00265317

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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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, Vascular endothelial
growth factor (VEGF) inhibitors or other angiogenic inhibitors


- History of or known brain metastases

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone
Official Title  ICMJE Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer
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 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: erlotinib
    erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
  • Drug: sunitinib
    Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
    Other Name: Sutent
  • Drug: placebo
    Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: erlotinib
    • Drug: sunitinib
  • Active Comparator: B
    Interventions:
    • Drug: erlotinib
    • Drug: placebo
Publications * Groen HJ, Socinski MA, Grossi F, Juhasz E, Gridelli C, Baas P, Butts CA, Chmielowska E, Usari T, Selaru P, Harmon C, Williams JA, Gao F, Tye L, Chao RC, Blumenschein GR Jr. A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). Ann Oncol. 2013 Sep;24(9):2382-9. doi: 10.1093/annonc/mdt212. Epub 2013 Jun 20.

*   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: May 10, 2011)
162
Original Enrollment  ICMJE
 (submitted: December 12, 2005)
136
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 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, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic 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 Canada,   Hungary,   Italy,   Netherlands,   Poland,   Romania,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00265317
Other Study ID Numbers  ICMJE A6181058
Has Data Monitoring Committee No
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 January 2013

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