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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
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Carcinoma of the Lung and Thymus

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients progression-free at 12 months

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230DIC03

NCT ID:

NCT01563354

Start Date:

June 2013

Completion Date:

December 2016

Related Keywords:

  • Neuroendocrine Carcinoma of the Lung and Thymus
  • neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus
  • Carcinoma
  • Lung Neoplasms
  • Carcinoma, Neuroendocrine

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