2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• •1. Histologically or cytologically confirmed NSCLC, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
• •2. Complete recovery from prior chemotherapy side effects to \< Grade 2.
• •3. At least one unidimensional measurable lesion meeting RECIST criteria.
• •4. ECOG PS 0-2.
• •5. Age \> 18 years.
• •6. Adequate organ function, including:
• •* Adequate bone marrow reserve: ANC \> 1.5 x 109/L, platelets \> 100 x 109/L.
• •* Hepatic: bilirubin \<1.5 x ULN, AP, ALT, AST \< 1.5 x ULN AP, ALT, and AST \<5 x ULN is acceptable if the liver has tumor involvement
• •* Renal: calculated creatinin clearance \> 40 ml/min based on the Cockcroft-Gault formula.
• •7. Estimated life expectancy \>12 weeks.
• •8. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
• •9. Signed informed consent.
• •10. Patient compliance and geographical proximity that allow adequate follow up.