Overview

This trial is active, not recruiting.

Condition neuroendocrine carcinoma of the lung and thymus
Treatments pasireotide lar, everolimus, pasireotide lar + everolimus
Phase phase 2
Targets mTOR, FKBP-12
Sponsor Novartis Pharmaceuticals
Start date August 2013
End date October 2016
Trial size 124 participants
Trial identifier NCT01563354, 2011-002872-17, CSOM230DIC03

Summary

This is a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study is 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 is expected that a total of 120 patients with 40 patients in each arm will be enrolled into this study. Patients with disease control (SD or better) in the combination arm or monotherapy with pasireotide LAR and everolimus and who are not experiencing unacceptable toxicity are permitted to continue treatment after the 12 month treatment period in the extension phase of the study. Primary Endpoint is defined as the proportion of patients who are progression-free at 9 months according to RECIST V 1.1

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
60 mg i.m. injected once every 28 days
pasireotide lar
60 mg i.m. injected once every 28 days
(Experimental)
10 mg p.o. daily
everolimus
10 mg p.o. daily
(Experimental)
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
pasireotide lar + everolimus
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily

Primary Outcomes

Measure
Proportion of patients progression-free at 9 months
time frame: 9 months

Secondary Outcomes

Measure
Progression-free survival
time frame: Every 3 months up to Year 1
Disease control rate
time frame: Every 3 months up to Year 1
Time to response
time frame: Every 3 months up to Year 1
Duration of response
time frame: Every 3 months up to Year 1
Biochemical response rate
time frame: Every 3 months up to Year 1
Rate and severity of adverse events
time frame: Week 2, 3, 4 and 7; every month up to 56 days after end of study treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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 can be 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 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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.