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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563354
First Posted: March 27, 2012
Last Update Posted: August 23, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
March 20, 2012
March 27, 2012
August 23, 2017
August 16, 2013
November 30, 2017   (Final data collection date for primary outcome measure)
Proportion of patients progression-free at 9 months [ Time Frame: 9 months ]
Proportion of patients progression-free at 12 months [ Time Frame: 12 months ]
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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Progression-free survival [ Time Frame: Every 3 months up to Year 1 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Active, not recruiting
124
November 30, 2017
November 30, 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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Greece,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
Switzerland
 
NCT01563354
CSOM230DIC03
2011-002872-17 ( EudraCT Number )
Yes
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2017

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