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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00457392Tipo: INTERVENTIONALInicio: 1 de jul de 2007Fin estimado: 1 de dic de 2012

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Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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

erlotinib

plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity

drug

placebo

Placebo daily by oral capsules in a continuous regimen

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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