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Multicenter 3-arm trial to evaluate the efficacy and safety of Pasireotide LAR or Everolimus alone or in combination in patients with well differentiated neuroendocrine carcinoma of the lung and thymus -LUNA Trial

Phase 2
Completed
Conditions
Lung carcinoid
Neuroendocrine tumor of the thymus
10029112
10014713
10029107
Registration Number
NL-OMON40411
Lead Sponsor
ovartis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
8
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 performancestatus 0-2;Other protocol-defined inclusion criteria may apply

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 exclusion criteria may apply

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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