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Brief Title: Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title: A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.
Study ID: NCT00754923
Brief Summary: RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * To determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free survival rate, in non-smokers or former light smokers with relapsed or refractory stage IIIB or IV non-small cell lung cancer. Secondary * To determine the 1-year survival rate in patients treated with this drug. * To assess the frequency and severity of adverse events associated with this drug in these patients. * To investigate the mutational status of EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase), ROS1, and K-Ras(Kirsten rat sarcoma viral oncogene homolog)in archived tumor samples from these patients. OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Archived tumor tissue samples are analyzed for mutations of EGFR, ALK, ROS1, and K-Ras by PCR (polymerase chain reaction) and DNA (deoxyribonucleic acid) sequencing. After completion of study treatment, patients are followed every 3 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ohio State University, Columbus, Ohio, United States
Name: Miguel A. Villalona, MD
Affiliation: Ohio State University
Role: PRINCIPAL_INVESTIGATOR