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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563354
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma of the Lung and Thymus Drug: Pasireotide LAR Drug: Everolimus Drug: Pasireotide LAR and Everolimus Combination Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 16, 2013
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : February 10, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pasireotide LAR
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
 Drug: Pasireotide LAR
60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1
Other Name: SOM230
Experimental: Everolimus
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
 Drug: Everolimus
10 mg tables administered orally once a day
Other Name: RAD001
Experimental: Pasireotide LAR and Everolimus Combination
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
 Drug: Pasireotide LAR and Everolimus Combination
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
Other Name: SOM230 + RAD001


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients progression-free at 9 months [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Every 3 months up to Year 1 ]
    Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1

  2. Disease control rate [ Time Frame: Every 3 months up to Year 1 ]
    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

  3. Time to response [ Time Frame: Every 3 months up to Year 1 ]
    Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1

  4. Duration of response [ Time Frame: Every 3 months up to Year 1 ]
    Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause

  5. Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ]
    Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA compared to baseline.

  6. 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563354


Locations
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Denmark
Novartis Investigative Site
Aarhus, Denmark, 8000 C
Novartis Investigative Site
Copenhagen N, Denmark, DK-2200
France
Novartis Investigative Site
Toulouse, Cedex 9, France, 31000
Novartis Investigative Site
Creteil, France, 94000
Novartis Investigative Site
Lille Cedex, France, 59037
Novartis Investigative Site
Lyon, France, 69437
Novartis Investigative Site
Rennes, France, 35043
Novartis Investigative Site
Strasbourg Cedex, France, 67091
Novartis Investigative Site
Villejuif Cedex, France, 94800
Germany
Novartis Investigative Site
Bad Berka, Germany, 99438
Novartis Investigative Site
Berlin, Germany, 13125
Novartis Investigative Site
Mainz, Germany, 55131
Greece
Novartis Investigative Site
Athens, GR, Greece, 115 27
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
Novartis Investigative Site
Brescia, BS, Italy, 25123
Novartis Investigative Site
Viagrande, CT, Italy, 95029
Novartis Investigative Site
Milano, MI, Italy, 20141
Novartis Investigative Site
Padova, PD, Italy, 35100
Novartis Investigative Site
Perugia, PG, Italy, 06129
Novartis Investigative Site
Parma, PR, Italy, 43100
Novartis Investigative Site
Roma, RM, Italy, 00128
Novartis Investigative Site
Orbassano, TO, Italy, 10043
Novartis Investigative Site
Napoli, Italy, 80131
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Spain
Novartis Investigative Site
Granada, Andalucia, Spain, 18014
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46014
Novartis Investigative Site
Barcelona, Spain, 08041
Novartis Investigative Site
Madrid, Spain, 28046
Sweden
Novartis Investigative Site
Lund, Sweden, 221 85
United Kingdom
Novartis Investigative Site
Withington, Greater Manchester, United Kingdom, M20 4BX
Novartis Investigative Site
Glasgow, United Kingdom, G12 0YN
Novartis Investigative Site
London, United Kingdom, NW3 2QG
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01563354    
Other Study ID Numbers: CSOM230DIC03
2011-002872-17 ( EudraCT Number )
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on

https://www.clinicalstudydatarequest.com/
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus,adult,SOM230,carcinoma,lung cancer,
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Neuroendocrine
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Everolimus
Pasireotide
Somatostatin
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists