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

• Status: Completed
• Trial end date: 2020-02-10
• Target enrollment: 0
• Participant gender: All

Summary

This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Pasireotide; Sirolimus; Somatostatin

Criteria

Inclusion Criteria:

• Histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus

• Patients of all treatment lines including naive patients could have been enrolled

• 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 who required symptomatic treatment with somatostatin analogs

• Prior therapy with mTOR inhibitors

• History of liver disease

• Baseline QTcF> 470 msec

• Uncontrolled diabetes mellitus despite adequate therapy