NCT01563354

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_2

Geographic Reach
9 countries

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 16, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

6.5 years

First QC Date

March 20, 2012

Results QC Date

February 4, 2021

Last Update Submit

March 8, 2021

Conditions

Neuroendocrine Carcinoma of the Lung and Thymus

Keywords

neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus,adult,SOM230,carcinoma,lung cancer,

Outcome Measures

Primary Outcomes (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".

    Baseline up to 9 months

Secondary Outcomes (11)

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

    Baseline, every 3 months up to 69 months

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

    Baseline, every 3 months up to 69 months

  • Summary of Time to Response (Months)

    Every 3 months up to Year 1

  • Summary of Duration of Response (Months)

    Every 3 months up to Year 1

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

    Baseline up to Month 12

  • +6 more secondary outcomes

Study Arms (3)

Pasireotide LAR

EXPERIMENTAL

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

Everolimus

EXPERIMENTAL

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

Drug: Everolimus

Pasireotide LAR and Everolimus Combination

EXPERIMENTAL

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

Interventions

Pasireotide LARDRUG

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

Also known as: SOM230
Pasireotide LAR
EverolimusDRUG

10 mg tables administered orally once a day

Also known as: RAD001
Everolimus
Pasireotide LAR and Everolimus CombinationDRUG

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

Also known as: SOM230 + RAD001
Pasireotide LAR and Everolimus Combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Novartis Investigative Site

Aarhus, 8000 C, Denmark

Location

Novartis Investigative Site

Copenhagen N, DK-2200, Denmark

Location

Novartis Investigative Site

Toulouse, Cedex 9, 31000, France

Location

Novartis Investigative Site

Créteil, 94000, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Lyon, 69437, France

Location

Novartis Investigative Site

Rennes, 35043, France

Location

Novartis Investigative Site

Strasbourg, 67091, France

Location

Novartis Investigative Site

Villejuif, 94800, France

Location

Novartis Investigative Site

Bad Berka, 99438, Germany

Location

Novartis Investigative Site

Berlin, 13125, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Athens, GR, 115 27, Greece

Location

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Viagrande, CT, 95029, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Padua, PD, 35100, Italy

Location

Novartis Investigative Site

Perugia, PG, 06129, Italy

Location

Novartis Investigative Site

Parma, PR, 43100, Italy

Location

Novartis Investigative Site

Roma, RM, 00128, Italy

Location

Novartis Investigative Site

Orbassano, TO, 10043, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

Novartis Investigative Site

Granada, Andalusia, 18014, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Oviedo, Principality of Asturias, 33006, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46014, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

Lund, 221 85, Sweden

Location

Novartis Investigative Site

Withington, Greater Manchester, M20 4BX, United Kingdom

Location

Novartis Investigative Site

Glasgow, G12 0YN, United Kingdom

Location

Novartis Investigative Site

London, NW3 2QG, United Kingdom

Location

Novartis Investigative Site

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29074099DERIVED

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

pasireotideEverolimus

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@Novartis.com
+ 1 862 778 8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 27, 2012

Study Start

August 16, 2013

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

April 2, 2021

Results First Posted

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

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/

Locations

SE(1)FR(7)DK(2)ES(6)NL(2)GR(1)IT(10)GB(4)DE(3)