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

This study is currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01563354
First received: March 20, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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. The number of evaluable patients enrolled is targeted to be approx. 108 with 36 evaluable patients randomized to each arm. 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. Primary Endpoint is defined as the proportion of patients progression-free at 12 months according to RECIST V 1.1


Condition Intervention Phase
Neuroendocrine Carcinoma of the Lung and Thymus
Drug: Pasireotide LAR
Drug: Everolimus
Drug: Pasireotide LAR + Everolimus
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients progression-free at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1

  • Disease control rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Proportion of patients showing a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1

  • Time to response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1

  • Duration of response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause

  • Time to progression [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from date of start of treatment to date of event defined as the first documented progression or death due to underling disease.

  • Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Percentage of patients showing normalization or a decrease > or = 50% of serum CgA, urinary 5HIAA

  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: August 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR
60 mg i.m. injected once every 28 days
Drug: Pasireotide LAR
60 mg i.m. injected once every 28 days
Experimental: Everolimus
10 mg p.o. daily
Drug: Everolimus
10 mg p.o. daily
Experimental: Pasireotide LAR + Everolimus
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
Drug: Pasireotide LAR + Everolimus
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmed advanced typical and atypical carcinoid tumors of the lung and 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563354

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 44 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01563354     History of Changes
Other Study ID Numbers: CSOM230DIC03, 2011-002872-17
Study First Received: March 20, 2012
Last Updated: March 25, 2014
Health Authority: France: National Agency for the Safety of Medicine and Health Products (ANSM)
Italy: Italian Medicines Agency (AIFA)
Sweden: Medical Products Agency (MPA)
Denmark: Danish Health and Medicines Authority
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Netherlands: Medicines Evaluation Board
Spain: Spanish Agency for Medicines and Health Products
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014