Clinical 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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002872-17-GB

Enrollment

124

Registered

2013-03-19

Start date

2013-06-24

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neouroendocrine carcinoma of the lung and thymus MedDRA version: 20.0 Level: LLT Classification code 10025064 Term: Lung carcinoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864

Interventions

Trade Name: Afinitor® Product Name: Everolimus Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Histological confirmed advanced typical and atypical carcinoid tumours of the lung and thymus •Patients of all treatment lines 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 Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44

Exclusion criteria

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 exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.;Secondary Objective: Progression-free survival Disease control rate Time to Response Duration of Response Biochemical response rate Rate and severity of AEs;Primary end point(s): Proportion of patients progression-free at 9 months;Timepoint(s) of evaluation of this end point: 9 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.;Secondary Objective: Progression-free survival Disease control rate Time to Response Duration of Response Biochemical response rate Rate and severity of AEs;Primary end point(s): Proportion of patients progression-free at 9 months;Timepoint(s) of evaluation of this end point: 9 months

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Secondary

Measure	Time frame
Secondary end point(s): - PFS : Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1 - Disease control rate : 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 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 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 : Percentage of patients showing normalization or a decrease > or equal 30% of serum CgA compared to baseline - Rate and severity of AEs;Timepoint(s) of evaluation of this end point: - Every 3 months up to 1 year - Every 3 months up to 1 year - Every 3 months up to 1 year - Every 3 months up to 1 year - Every 3 months up to 1 year - Week 2, 3, 4 and 7; every month up to 56 days after end of study treatment	—

Measure

Time frame

Secondary end point(s): - PFS : Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1 - Disease control rate : 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 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 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 : Percentage of patients showing normalization or a decrease > or equal 30% of serum CgA compared to baseline - Rate and severity of AEs;Timepoint(s) of evaluation of this end point: - Every 3 months up to 1 year - Every 3 months up to 1 year - Every 3 months up to 1 year - Every 3 months up to 1 year - Every 3 months up to 1 year - Week 2, 3, 4 and 7; every month up to 56 days after end of study treatment

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Countries

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

Contacts

Public ContactMedical Collaboration Centre

Novartis Pharmaceuticals UK Ltd

medinfo.uk@novartis.com01276698370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026