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

Novartis

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Carcinoma of the Lung and Thymus

Treatments: Drug: Pasireotide LAR; Drug: Pasireotide LAR and Everolimus Combination; Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563354

2011-002872-17 (EudraCT Number)

CSOM230DIC03

Details and patient eligibility

About

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

Full description

This was a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study was to test the effectiveness and safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the lung and thymus. It was expected that a total of 120 patients with 40 patients in each arm were to be enrolled into this study. Patients were seen weekly for one month and monthly thereafter. Radiological and biochemical response assessments were performed every 3 months.

Patients with disease control (stable disease or better) in the combination arm or monotherapy with pasireotide LAR and everolimus who had not experienced unacceptable toxicity were permitted to continue treatment in the extension phase of the study and were seen every 3 months. Patients could remain in the extension phase as long as they continued to have clinical benefit and had not fulfilled any of the study discontinuation criteria. All patients had a safety follow-up visit 56 days after last treatment dose.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 3 patient groups

Pasireotide LAR

Experimental group

Description:

Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1

Treatment:

Drug: Pasireotide LAR

Everolimus

Experimental group

Description:

Everolimus 10 mg taken orally (p.o) once daily starting on Day 1

Treatment:

Drug: Everolimus

Pasireotide LAR and Everolimus Combination

Experimental group

Description:

Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1

Treatment:

Drug: Pasireotide LAR and Everolimus Combination