Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

  • Stage IIIB or IV disease
  • Recurrent disease after prior surgery, chemotherapy, or radiotherapy
  • No squamous cell histology or mixed tumor with > 50% squamous cells
• Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked > 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago)

• No known brain metastasis

  • Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

• ECOG(Eastern Cooperative Oncology Group)performance status 0-2
• ANC (Absolute Neutrophil Count)≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin ≤ 1.5 mg/dL
• Creatinine clearance ≥ 50 mL/min
• INR (International Normalized Ratio) < 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment

• No cardiac disease, including any of the following:

  • New York Heart Association class III-IV congestive heart failure
  • Unstable angina (anginal symptoms at rest)
  • New-onset angina within the past 3 months
  • Myocardial infarction within the past 6 months
• No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management
• No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
• No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks
• No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
• No active clinically serious infection > CTCAE grade 2
• No serious non-healing wound, ulcer, or bone fracture
• No evidence or history of bleeding diathesis or coagulopathy
• No known HIV infection or chronic hepatitis B or C

• No other malignancy except for any of the following:

  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence
• No condition that impairs the patient's ability to swallow whole pills
• No malabsorption problems
• No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study
• No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No more than one prior systemic chemotherapy treatment for metastatic disease

  • Prior treatment with EGFR inhibitors is not considered chemotherapy
• More than 4 weeks since prior major surgery or open biopsy
• No prior sorafenib tosylate
• No concurrent St. John's wort or rifampin
• Concurrent anticoagulation with warfarin or heparin allowed