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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
Results First Posted : April 2, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

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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


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




Primary Outcome Measures :
  1. Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) [ Time Frame: Baseline up to 9 months ]
    Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".


Secondary Outcome Measures :
  1. Summary of Progression-free Survival (PFS) Based on RECIST v1.1 [ Time Frame: Baseline, every 3 months up to 69 months ]
    Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1

  2. Kaplan-Meier Estimates of Progression-free Survival (PFS) [ Time Frame: Baseline, every 3 months up to 69 months ]
    Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1.

  3. Summary of Time to Response (Months) [ 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. Summary of Duration of Response (Months) [ Time Frame: Every 3 months up to Year 1 ]
    Date of first objective tumor response to date of tumor progression or death due to any cause.

  5. 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) [ Time Frame: Baseline up to Month 12 ]
    Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1.

  6. Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels [ Time Frame: Baseline up to Week 52 ]
    Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.

  7. Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) [ Time Frame: Baseline up to Month 18 ]
    Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.

  8. Kaplan-Meier Event-free Probability Estimate Based on CgA Levels [ Time Frame: Baseline, every 3 months up to Month 18 ]
    Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels >= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point.

  9. Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment [ Time Frame: Baseline up Month 24 ]
    Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.

  10. Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels [ Time Frame: Baseline, every 3 months up to Month 24 ]
    Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels >= 25% compared to baseline or deaths due to any cause.

  11. Biochemical Response Rate (BRR) for 5HIAA Levels [ Time Frame: Baseline up Week 52 ]
    The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of >= 50% from baseline of 5HIAA concentrations.



Information from the National Library of Medicine

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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

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
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] November 7, 2016
Statistical Analysis Plan  [PDF] April 1, 2020

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
Results First Posted: April 2, 2021
Last Update Posted: April 2, 2021
Last Verified: March 2021
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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Everolimus
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
Pasireotide
Somatostatin
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists