Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC)

The combination of chemotherapy \[such as docetaxel\] with continuous administration of targeted drugs which block the molecular machinery of cancer cell growth \[such as erlotinib\] have failed to improve their efficacy over only-chemotherapy in patients with metastatic lung cancer of the non-small cell histology type. It is not yet known whether administering targeted drugs intermittently could result in improved efficacy of the combinations. This is a multicenter randomized Phase II trial aiming to determine the more active dosing sequence between intermittent erlotinib and docetaxel for treating patients with advanced Non-Small-Lung-Cancer.Patients will be randomly assigned to one of two treatment arms: they will receive a 12-days course of erlotinib either before docetaxel \[arm A\] or after docetaxel administration \[arm B\].Treatment will be repeated every 21 days.Patients will be evaluated every 2 cycles (\~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy up to a total 8 cycles. Those patients experiencing progressive disease will be taken off study. Biopsy material will be assessed for biomarkers.