Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer
This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer
treated with sorafenib.
II. Determine the clinical toxic effects of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the 24-week progression-free survival rate in patients treated with this drug.
II. Determine the overall survival of patients treated with this drug. III. Determine the
time to disease progression in patients treated with this drug.
IV. Correlate predictive disease markers (K-ras and B-raf mutations and ERK/pERK, AKT/pAKT,
and VEGFR2/p-VEGFR2 expression) in these patients with the activity of this drug.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 5 years.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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