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.
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.
