Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy

A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.

Inclusion criteria:

• Age over 18 years
• Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin
• Only 1-2 previous chemotherapy regimens for advanced disease
• More than 2 weeks from previous surgery, radiation or chemotherapy
• Ability to perform normal daily functions

Exclusion criteria:

• Chronic steroid treatment
• Prior treatment with EGFR inhibitors
• Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions
• Other cancers within the past 2 years
• Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply