Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy

This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.

Inclusion criteria:

• Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
• Age ≥ 18 years
• WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
• Adequate bone marrow, liver and renal function

Exclusion criteria:

• Chronic steroid treatment
• Prior treatment with chemotherapy for advanced lung cancer
• Prior treatment with mTOR inhibitors
• Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
• Symptomatic or uncontrolled brain metastases
• Other cancers within the past 5 years
• Pregnant or breastfeeding women

Other protocol-defined inclusion/exclusion criteria may apply.