Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

Inclusion Criteria: * Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of GI or lung origin * No history of and no active symptoms related to carcinoid syndrome * In addition to treatment-naive patients, patients previously treated with SSA, Interferon (IFN), one prior line of chemotherapy, and/or PRRT were allowed into the study. Pretreated patients had to have progressed on or after the last treatment * Radiological documented disease progression within 6 months prior to randomization * Measurable disease * WHO performance status ≤1 * Adequate bone marrow, liver and renal function Exclusion Criteria: * Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell carcinoma * Patients with pancreatic NET or NET of origins other than GI or Lung * Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing, diarrhea) * Patients with more than one line of prior chemotherapy * Prior targeted therapy * Hepatic intra-arterial embolization within the last 6 months. Cryoablation or radiofrequency ablation of hepatic metastases within 2 months of randomization * Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus) * Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus) * Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus * Uncontrolled diabetes mellitus as defined by HbA1c \>8% despite adequate therapy * Patients who had any severe and/or uncontrolled medical conditions such as: * unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia * active or uncontrolled severe infection * liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) * Chronic treatment with corticosteroids or other immunosuppressive agents * Known history of HIV seropositivity * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria might apply.