AzTrials
AzTrials

Neuroendocrine Carcinoma of the Lung and ThymusPhase 2LUNANCT01563354

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

A Phase 2 study testing Pasireotide LAR, Everolimus and Pasireotide LAR and Everolimus Combination in people with Neuroendocrine Carcinoma of the Lung and Thymus, run by Novartis Pharmaceuticals at 36 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pasireotide LAR, Everolimus and Pasireotide LAR and Everolimus Combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
36 sitesin 9 countries
Study dates
16 Aug 2013to 10 Feb 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

36 sites in 9 countries.

36 sites in 9 countries

Italy10 sites

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Padova, PD, 35100

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Viagrande, CT, 95029

Other trials in Italy

France7 sites

  • Novartis Investigative Site

    Créteil, 94000

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Lyon, 69437

  • Novartis Investigative Site

    Rennes, 35043

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulouse, Cedex 9, 31000

  • Novartis Investigative Site

    Villejuif, 94800

Other trials in France

Spain6 sites

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Valencia, Valencia, 46014

Other trials in Spain

United Kingdom4 sites

  • Novartis Investigative Site

    Glasgow, G12 0YN

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Withington, Greater Manchester, M20 4BX

Other trials in United Kingdom

Germany3 sites

  • Novartis Investigative Site

    Bad Berka, 99438

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Mainz, 55131

Other trials in Germany

Denmark2 sites

  • Novartis Investigative Site

    Aarhus, 8000 C

  • Novartis Investigative Site

    Copenhagen N, DK-2200

Other trials in Denmark

Netherlands2 sites

  • Novartis Investigative Site

    Amsterdam, 1066 CX

  • Novartis Investigative Site

    Groningen, 9713 GZ

Other trials in Netherlands

Greece1 site

  • Novartis Investigative Site

    Athens, GR, 115 27

Other trials in Greece

Sweden1 site

  • Novartis Investigative Site

    Lund, 221 85

Other trials in Sweden

About this study

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

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

Read the 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.

Being tested
Pasireotide LAR, Everolimus, Pasireotide LAR and Everolimus Combination
Keywords
neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus,adult,SOM230,carcinoma,lung cancer,
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pasireotide LARDrug

    Also called SOM230

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

  • EverolimusDrug

    Also called RAD001

    10 mg tables administered orally once a day

  • Pasireotide LAR and Everolimus CombinationDrug

    Also called SOM230 + RAD001

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

Study groups in NCT01563354
Study groupRoleWhat they receive
Pasireotide LARExperimentalPasireotide 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
Receives: Drug: Pasireotide LAR
EverolimusExperimentalEverolimus 10 mg taken orally (p.o) once daily starting on Day 1
Receives: Drug: Everolimus
Pasireotide LAR and Everolimus CombinationExperimentalPasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
Receives: Drug: Pasireotide LAR and Everolimus Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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".

    Measured: Baseline up to 9 months

Secondary outcomes (11)

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

    Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1

    Measured: Baseline, every 3 months up to 69 months

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

    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.

    Measured: Baseline, every 3 months up to 69 months

  3. Summary of Time to Response (Months)

    Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1.

    Measured: Every 3 months up to Year 1

  4. Summary of Duration of Response (Months)

    Date of first objective tumor response to date of tumor progression or death due to any cause.

    Measured: Every 3 months up to Year 1

  5. 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)

    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.

    Measured: Baseline up to Month 12

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

    Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.

    Measured: Baseline up to Week 52

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

    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.

    Measured: Baseline up to Month 18

  8. Kaplan-Meier Event-free Probability Estimate Based on CgA Levels

    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.

    Measured: Baseline, every 3 months up to Month 18

  9. Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment

    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.

    Measured: Baseline up Month 24

  10. Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels

    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.

    Measured: Baseline, every 3 months up to Month 24

  11. Biochemical Response Rate (BRR) for 5HIAA Levels

    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.

    Measured: Baseline up Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2012 (estimated)
  2. Study start16 Aug 2013
  3. Primary completion10 Feb 2020
  4. Study completion10 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563354
Sponsor's protocol ID
CSOM230DIC03
Other IDs
2011-002872-17
Acronym
LUNA
Status last verified
Mar 2021
First submitted
20 Mar 2012
Last updated
2 Apr 2021
Data monitoring committee
Yes
Individual data sharing
Yes: 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/

Publications

  • Ferolla P, Brizzi MP, Meyer T, Mansoor W, Mazieres J, Do Cao C, Lena H, Berruti A, Damiano V, Buikhuisen W, Gronbaek H, Lombard-Bohas C, Grohe C, Minotti V, Tiseo M, De Castro J, Reed N, Gislimberti G, Singh N, Stankovic M, Oberg K, Baudin E. 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. Lancet Oncol. 2017 Dec;18(12):1652-1664. doi: 10.1016/S1470-2045(17)30681-2. Epub 2017 Oct 23.

    PubMed 29074099

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pasireotide LAR, Everolimus and Pasireotide LAR and Everolimus Combination in people with Neuroendocrine Carcinoma of the Lung and Thymus, run by Novartis Pharmaceuticals at 36 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Italy, France, Spain, United Kingdom, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563354, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in