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

NCT01563354 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2021-04-02

Study results available
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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

Conditions

  • Neuroendocrine Carcinoma of the Lung and Thymus

Interventions

DRUG

Pasireotide LAR

60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1

DRUG

Everolimus

10 mg tables administered orally once a day

DRUG

Pasireotide LAR and Everolimus Combination

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-16
Primary Completion
2020-02-10
Completion
2020-02-10

Countries

  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563354 on ClinicalTrials.gov