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 are allowed into the
study. Pretreated patients must 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 locoregional therapy within the last 6 months

- 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 have 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 may apply.