3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial

• Progression-free survival [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
  Time from first study drug administration to objective tumor progression or death from any cause
• Disease control rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
  Proportion of patients showing a best overall response of complete response, partial response or stable disease during 12 months of treatment
• Time to response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
  Time from start of treatment to the first observed objective tumor response (partial response or complete response)
• Duration of response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
  Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause
• Time to progression [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
  Time from date of start of treatment to date of event defined as the first documented progression or death due to underling disease.
• Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
  Percentage of patients showing normalization or a decrease > or = 50% of serum CgA, urinary 5HIAA
• Rate and severity of adverse events [ Time Frame: Week 2, 3 and 4; every month up to Year 3 ] [ Designated as safety issue: Yes ]

The purpose of this study is to test the effectiveness and safety of everolimus or pasireotide LAR alone or in combination in patients with your disease.

More specifically, this study aims to find out if the study drugs everolimus or pasireotide LAR alone or in combination (LAR stands for long-acting release) are safe and have beneficial effects in patients who have a neuroendocrine carcinoma of the lung and thymus. The studied treatment aims to shrink tumor size or stop the progression of your disease. The assessment will be based on measuring changes in the size of the tumor.

• Drug: Pasireotide LAR
  60 mg i.m. injected once every 28 days
• Drug: Everolimus
  10 mg p.o. daily
• Drug: Pasireotide LAR + Everolimus
  Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily

• Experimental: Pasireotide LAR
  60 mg i.m. injected once every 28 days
  Intervention: Drug: Pasireotide LAR
• Experimental: Everolimus
  10 mg p.o. daily
  Intervention: Drug: Everolimus
• Experimental: Pasireotide LAR + Everolimus
  Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
  Intervention: Drug: Pasireotide LAR + Everolimus

Inclusion Criteria:

• Histological confirmed advanced well differentiated carcinoma of the lung and thymus
• Patients of all treatment lines can be included
• At least one measurable lesion of disease on CT scan or MRI
• Radiological documentation of disease progression within 12 months prior to randomization
• Adequate liver, renal and bone marrow function
• WHO Performance Status 0-2

Exclusion Criteria:

• Poorly differentiated neuroendocrine carcinoma
• Non-neuroendocrine thymoma
• Patients with severe functional disease requiring symptomatic treatment with somatostatin analogs
• Prior therapy with mTOR inhibitors
• History of liver disease
• Baseline QTcF> 470 msec
• Uncontrolled diabetes mellitus despite adequate therapy

Other protocol-defined inclusion/exclusion criteria may apply.