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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name LUNA

NCTNCT01563354 (opens ClinicalTrials.gov in a new tab)Other idCSOM230DIC03Other id2011-002872-17
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
124 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
9 countries

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

Start
16 Aug 2013
Primary completion
10 Feb 2020
Completion
10 Feb 2020
First posted
27 Mar 2012 (estimated)
Last update posted
2 Apr 2021
Conditions
Neuroendocrine Carcinoma of the Lung and Thymus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201620182020
  1. Ph 2

    LUNA

    NCT01563354

    16 Aug 2013 to 10 Feb 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Pasireotide LARDrug
  • EverolimusDrug
  • Pasireotide LAR and Everolimus CombinationDrug

Arms3

  • 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

  • Experimental

    Everolimus

    Everolimus 10 mg taken orally (p.o) once daily starting on Day 1

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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 outcomes(11)

  1. Summary of Progression-free Survival (PFS) Based on RECIST v1.1

    Time frame · Baseline, every 3 months up to 69 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline up to 9 months

Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)

GroupValue (percentage of participants)
Pasireotide LAR0
Everolimus0
Pasireotide LAR and Everolimus Combination0
Secondary and other outcome results(7)
Secondary outcomeMedian· Baseline, every 3 months up to 69 months

Summary of Progression-free Survival (PFS) Based on RECIST v1.1

GroupValue (months)
Pasireotide LAR8.51
Everolimus12.48
Pasireotide LAR and Everolimus Combination16.53
Secondary outcomeNumber· Baseline, every 3 months up to 69 months

Kaplan-Meier Estimates of Progression-free Survival (PFS)

GroupValue (event free probability estimates)
Pasireotide LAR83.6
Everolimus91.2
Pasireotide LAR and Everolimus Combination88.6
Secondary outcomeNumber· Every 3 months up to Year 1

Summary of Time to Response (Months)

GroupValue (months)
Pasireotide LARNA
EverolimusNA
Pasireotide LAR and Everolimus CombinationNA
Secondary outcomeNumber· Every 3 months up to Year 1

Summary of Duration of Response (Months)

GroupValue (months)
Pasireotide LARNA
EverolimusNA
Pasireotide LAR and Everolimus CombinationNA
Secondary outcomeNumber· Baseline up to Month 12

12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)

GroupValue (percentage of participants)
Pasireotide LAR2.4
Everolimus2.4
Pasireotide LAR and Everolimus Combination4.9
Secondary outcomeNumber· Baseline up to Week 52

Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels

GroupValue (percentage of participants)
Pasireotide LAR20.6
Everolimus7.4
Pasireotide LAR and Everolimus Combination17.1
Secondary outcomeMedian· Baseline up to Month 18

Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set)

GroupValue (months)
Pasireotide LAR14.75
Everolimus2.00
Pasireotide LAR and Everolimus Combination8.38

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pasireotide LARPasireotide LAR2 / 4117 / 4140 / 41
EverolimusEverolimus7 / 4220 / 4242 / 42
Pasireotide LAR and Everolimus CombinationPasireotide LAR and Everolimus Combination3 / 4116 / 4140 / 41

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

11 results

Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial.

Ferolla et al. 2017The Lancet. Oncologycited by 108

PMID 29074099DOI 10.1016/s1470-2045(17)30681-2PUB-29074099

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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