Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

Exclusion Criteria

• •1. Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone, and a disease-free survival (DFS) \>=3 years.
• •2. Pregnancy or lactation. All females of child-bearing potential must have negative serum or urine pregnancy tests within 7 days prior to study treatment.
• •3. Prior epithelial growth factor receptor (EGFR) inhibitors, with the exception of erlotinib, are not allowed. This includes both tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. Prior vascular endothelial growth factor (VEGF) inhibitors, with the exception of bevacizumab, are not allowed.
• •4. Significant cardiac disease within 90 days of starting study treatment including:
• •* superior vena cava syndrome
• •* new onset angina
• •* congestive heart failure (CHF) \> Class 2 per New York Heart Association (NYHA) classification
• •* arrhythmia
• •* valvular heart disease.
• •5. Myocardial infarction within 6 months prior to initiation of study treatment
• •6. Cardiomegaly on chest imaging or ventricular hypertrophy on electrocardiogram (ECG) unless the left ventricular ejection fraction (LVEF) is within normal range for the institution.
• •7. Poorly controlled hypertension (defined as systolic blood pressure \[BP\] \>150 mm Hg and/or diastolic BP \>100 mm Hg on antihypertensive medications).
• •8. Unstable angina (anginal symptoms at rest).
• •9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• •10. Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
• •11. A serious active infection (\> grade 2) at the time of treatment
• •12. A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• •13. Untreated brain metastases. Patients who have treated metastases \>=4 weeks out (with surgery and/or radiation therapy) and no evidence of central nervous system (CNS) progression are eligible.
• •14. Treatment with a non-approved or investigational drug within 28 days of initial study treatment.
• •15. A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment or anticipation of need for major surgery during the course of the study.
• •16. Thrombolic or embolic events such as a stroke and transient ischemic attack (TIA) within the past 6 months.
• •17. Any prior history of hypertensive crisis or hypertensive encephalopathy.
• •18. Pulmonary hemorrhage/bleeding event \>= grade 2 within 28 days of initial study treatment.
• •19. Any other non-pulmonary hemorrhage/bleeding event \>= grade 3 within 28 days of initial study treatment.
• •20. Evidence or history of bleeding diathesis or coagulopathy.
• •21. Serious non-healing wound, ulcer, or bone fracture.
• •22. Use of St. John's Wort or rifampin (rifampicin).
• •23. Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
• •24. Any malabsorption problem.
• •25. Any condition that impairs the patient's ability to swallow whole pills.