Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)

Inclusion Criteria

• •Diagnosis of non-operable, locally advanced, recurrent or metastatic, histologically or cytologically documented non-small cell lung cancer (stage IIIB or IV).
• •* Patients should have an evidence of measurable disease.
• •* 18 years or older
• •* Eastern Cooperative Oncology Group - Performance Status 0-3
• •* At least 12 weeks of life expectancy
• •* Patients with non-small cell lung cancer stages IIIB/IV who have received at least one cycle of platinum-based, first or second line systemic standard chemotherapy, and have a documented failure for this treatment.
• •* More than 2 previous chemotherapy regimens are not allowed. The patients should have recovered from any toxic effect and at least 2 weeks should have elapsed from last dose before their entry (14 days for vinorelbine and other vinca alkaloids or gemcitabine). Patients who in the investigator's opinion are fully recovered from surgery for at least 4 weeks may also be considered for the study. Patients should have recovered from any severe toxicity (CTC \> 1) caused by any previous therapy.
• •* Granulocyte count \> 1.5x 109/L and platelet count \> 100x 109/L.
• •* Serum bilirubin \> 1.5 upper limit of normal (ULN)
• •* AST and/or ALT \> 2 ULN (or \>5 x ULN when clearly attributable to presence of hepatic metastases).
• •* Serum creatinine \> 1.5 ULN or creatinine clearance \< 60 mL/min
• •* Capability to fulfill the study and follow-up procedures.
• •* A negative pregnancy test should be obtained from all women of childbearing potential within 72 hours previous to therapy beginning.
• •* Patients of reproductive potential should use effective contraceptive methods.
• •* Written (signed) informed consent to participate in the study