Extract

Overall, this study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced NSCLC previously treated only with hemotherapy as systemic therapy. The study consists of two consecutive phases, the primary aims of which are: In phase 1 • To assess the feasibility (in terms of both dose and schedule) of combined daily or weekly administration of RAD001 with daily erlotinib based on evaluation of safety and PK drug-drug interaction and to establish the appropriate doses to carry forward into phase 2. In phase 2 • To estimate the Disease Control Rate at 3 months (DCR at 3 months) as measure of anti-tumor activity in patients who receive RAD001 (daily and/or weekly schedule) together with daily erlotinib as compared to the DCR at 3 months in patients who receive erlotinib alone.

Inclusion criteria

• Lung cancer is one of the most common malignancies in developed countries and accounts for millions of deaths worldwide. Two-thirds of NSCLC patients have advanced disease and are considered incurable by surgery or chest radiation. The current standard of care for these patients is chemotherapy. Novel therapeutic agents are under development. Epidermal growth factor inhibitors have already demonstrated a clinical benefit to patients with advanced NSCLC failing standard chemotherapy regimens

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