Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria

• •1. Patients must have biopsy proven NSCLC that is locally advanced or metastatic.
• •2. Patients must have had failure of at least one prior chemotherapy regimen.
• •3. Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.
• •4. Age ≥ 18 years
• •5. Patients must have measurable disease at baseline.
• •6. Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by PET scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of SBRT.
• •1. For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
• •3. Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
• •4. Up to 2 contiguous vertebral metastases will be considered a single site of disease.
• •7. Patients must have a KPS \>60
• •8. AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
• •9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
• •10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
• •11. Females of childbearing potential should have a negative pregnancy test.
• •12. Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
• •13. Patients must provide verbal and written informed consent to participate in the study.
• •14. Total bilirubin: within normal institutional limits