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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Ohio State University
Columbus, Ohio, United States
Progression-free Survival at 6 Months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate
Time frame: 6 months
Overall Survival Rate
Determine the one year survival rate in Non/Light smokers with advanced and previouslytreated NSCLC
Time frame: Up to 2 years
Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)
Assess the frequency and severity of adverse events associated with Sorafenib in this patient population Non/Light smokers with advanced and previously treated NSCLC.
Time frame: Up to 2 years
Mutational Status for EGFR or Kras
Time frame: up to 2 years
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