| A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
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| 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
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| 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.
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| Not Provided
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| Interventional
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| Phase 3
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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| Carcinoma, Non-Small Cell Lung
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- 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
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- Experimental: 1
Interventions:
- Drug: erlotinib
- Drug: sunitinib
- Active Comparator: 2
Interventions:
- Drug: erlotinib
- Drug: placebo
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| Not Provided
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| Completed
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| 960
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| 956
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| December 2012
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| July 2010 (Final data collection date for primary outcome measure)
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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
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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| 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
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| NCT00457392
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A6181087
SUN1087
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| Yes
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| Not Provided
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| September 2013
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