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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01563354
First received: March 20, 2012
Last updated: October 24, 2014
Last verified: October 2014

March 20, 2012
October 24, 2014
August 2013
February 2017   (final data collection date for primary outcome measure)
Proportion of patients progression-free at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Proportion of patients progression-free at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01563354 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1
  • Disease control rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    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
  • Time to response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1
  • Duration of response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause
  • Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA compared to baseline.
  • 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 ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from first study drug administration to objective tumor progression or death from any cause
  • Disease control rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Proportion of patients showing a best overall response of complete response, partial response or stable disease during 12 months of treatment
  • Time to response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from start of treatment to the first observed objective tumor response (partial response or complete response)
  • Duration of response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause
  • Time to progression [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Time from date of start of treatment to date of event defined as the first documented progression or death due to underling disease.
  • Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]
    Percentage of patients showing normalization or a decrease > or = 50% of serum CgA, urinary 5HIAA
  • Rate and severity of adverse events [ Time Frame: Week 2, 3 and 4; every month up to Year 3 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
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 is a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study is 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 is expected that a total of 120 patients with 40 patients in each arm will be enrolled into this study. Patients with disease control (SD or better) in the combination arm or monotherapy with pasireotide LAR and everolimus and who are not experiencing unacceptable toxicity are permitted to continue treatment after the 12 month treatment period in the extension phase of the study. Primary Endpoint is defined as the proportion of patients who are progression-free at 9 months according to RECIST V 1.1

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuroendocrine Carcinoma of the Lung and Thymus
  • Drug: Pasireotide LAR
    60 mg i.m. injected once every 28 days
  • Drug: Everolimus
    10 mg p.o. daily
  • Drug: Pasireotide LAR + Everolimus
    Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
  • Experimental: Pasireotide LAR
    60 mg i.m. injected once every 28 days
    Intervention: Drug: Pasireotide LAR
  • Experimental: Everolimus
    10 mg p.o. daily
    Intervention: Drug: Everolimus
  • Experimental: Pasireotide LAR + Everolimus
    Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
    Intervention: Drug: Pasireotide LAR + Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2017
February 2017   (final data collection date for primary outcome measure)

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 can be 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 requiring symptomatic treatment with somatostatin analogs
  • Prior therapy with mTOR inhibitors
  • History of liver disease
  • Baseline QTcF> 470 msec
  • Uncontrolled diabetes mellitus despite adequate therapy

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals
Spain,   Denmark,   France,   Germany,   Greece,   Italy,   Netherlands,   United Kingdom,   Sweden,   Switzerland
 
NCT01563354
CSOM230DIC03, 2011-002872-17
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP