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.

Ferolla P, Brizzi MP, Meyer T, Mansoor W, Mazieres J, Do Cao C, Léna H, Berruti A, Damiano V, Buikhuisen W, Grønbæk H, Lombard-Bohas C and 10 more

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Grohé C, Minotti V, Tiseo M, De Castro J, Reed N, Gislimberti G, Singh N, Stankovic M, Öberg K, Baudin E

The Lancet. Oncology23 Oct 2017Cited by 108 (Europe PMC)

PMID29074099DOI10.1016/s1470-2045(17)30681-2PepBankPUB-29074099

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In advanced lung or thymic carcinoids, month 9 disease control was 39.0% with pasireotide versus 33.3% with everolimus.
In plain wordsIn advanced lung or thymic carcinoids, month 9 disease control was 39.0% with pasireotide versus 33.3% with everolimus.
Peptide
Pasireotide
Outcome
IncreaseMonth 9 disease control versus everolimus
Study
n = 83
Comparator
Everolimus alone
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 28 days · intramuscularAs given in this study (human).
Measurements
Patients with CR, PR or stable disease at month 9
39%
pasireotide group, 16 of 41 patients
95% CI of proportion with CR, PR or stable disease
24.2 to 55.5%
pasireotide group, month 9
Patients with CR, PR or stable disease at month 9
33.3%
everolimus group, 14 of 42 patients
95% CI of proportion with CR, PR or stable disease
19.6 to 49.5%
everolimus group, month 9
Source sentences
Summary
At month 9, the proportion of patients with an overall lesion assessment of complete response, partial response, or stable disease was 16 of 41 patients (39·0%, 95% CI 24·2-55·5) in the long-acting pasireotide group, 14 of 42 patients (33·3%, 19·6-49·5) in the everolimus group, and 24 of 41 patients…
2 context sentences(design, population, supporting numbers)
Summary · context
The randomisation allocation sequence was generated by an external company; patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days), everolimus (10 mg orally once daily), or both in combination, for the core 12-month treatment period.
Summary · context
The primary endpoint was the proportion of patients progression-free at month 9, defined as the proportion of patients with overall lesion assessment at month 9 showing a complete response, partial response, or stable disease according to local Response Evaluation Criteria in Solid Tumors, version 1…
Report a problemFND-2907409910
02HumanRandomized controlled trialEfficacy outcome
In advanced lung or thymic carcinoids, month 9 disease control was 58.5% with pasireotide plus everolimus versus 33.3% with everolimus alone.
In plain wordsIn advanced lung or thymic carcinoids, month 9 disease control was 58.5% with pasireotide plus everolimus versus 33.3% with everolimus alone.
Peptide
Pasireotide
Outcome
IncreaseMonth 9 disease control with pasireotide added to everolimus
Study
n = 83
Comparator
Everolimus alone
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 28 days · intramuscularAs given in this study (human).
Measurements
Patients with CR, PR or stable disease at month 9
58.5%
pasireotide plus everolimus group, 24 of 41 patients
95% CI of proportion with CR, PR or stable disease
42.1 to 73.7%
pasireotide plus everolimus group, month 9
Patients with CR, PR or stable disease at month 9
33.3%
everolimus alone group, 14 of 42 patients
95% CI of proportion with CR, PR or stable disease
19.6 to 49.5%
everolimus alone group, month 9
Source sentences
Summary
At month 9, the proportion of patients with an overall lesion assessment of complete response, partial response, or stable disease was 16 of 41 patients (39·0%, 95% CI 24·2-55·5) in the long-acting pasireotide group, 14 of 42 patients (33·3%, 19·6-49·5) in the everolimus group, and 24 of 41 patients…
2 context sentences(design, population, supporting numbers)
Summary · context
The randomisation allocation sequence was generated by an external company; patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days), everolimus (10 mg orally once daily), or both in combination, for the core 12-month treatment period.
Summary · context
The primary endpoint was the proportion of patients progression-free at month 9, defined as the proportion of patients with overall lesion assessment at month 9 showing a complete response, partial response, or stable disease according to local Response Evaluation Criteria in Solid Tumors, version 1…
Report a problemFND-2907409911
03HumanNon-randomized trialEfficacy outcome
In advanced lung or thymic carcinoids, pasireotide monotherapy achieved complete response, partial response, or stable disease in 39.0% at month 9 (16/41).
In plain wordsIn advanced lung or thymic carcinoids, 39.0% receiving pasireotide alone had complete response, partial response, or stable disease at month 9.
Peptide
Pasireotide
Outcome
Not applicableProgression-free at month 9
Study
n = 41
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 28 days · intramuscularAs given in this study (human).
Measurements
Patients with CR, PR or stable disease at month 9
39%
pasireotide group, 16 of 41 patients
Patients with CR, PR or stable disease at month 9
16 patients
pasireotide group, of 41
95% CI of proportion with CR, PR or stable disease
24.2 to 55.5%
pasireotide group, month 9
Source sentences
Summary
At month 9, the proportion of patients with an overall lesion assessment of complete response, partial response, or stable disease was 16 of 41 patients (39·0%, 95% CI 24·2-55·5) in the long-acting pasireotide group,
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the proportion of patients progression-free at month 9, defined as the proportion of patients with overall lesion assessment at month 9 showing a complete response, partial response, or stable disease according to local Response Evaluation Criteria in Solid Tumors, version 1…
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409901
04HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, suspected pasireotide-related grade 1-2 diarrhoea occurred in 15/41 patients (37%).
In plain wordsIn advanced lung or thymic carcinoids, 37% receiving pasireotide alone experienced suspected treatment-related grade 1-2 diarrhoea.
Peptide
Pasireotide
Outcome
Not applicableGrade 1-2 diarrhoea
Study
n = 41
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Measurements
Patients with grade 1-2 diarrhoea
37%
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Patients with grade 1-2 diarrhoea
15 patients
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Source sentences
Summary
The most common grade 1-2 adverse events with a suspected association with long-acting pasireotide monotherapy were diarrhoea (15 [37%] of 41), hyperglycaemia (17 [41%]), and weight loss (8 [20%]);
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409902
05HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, suspected pasireotide-related grade 1-2 hyperglycaemia occurred in 17 patients (41%).
In plain wordsIn advanced lung or thymic carcinoids, 41% receiving pasireotide alone experienced suspected treatment-related grade 1-2 high blood glucose.
Peptide
Pasireotide
Outcome
Not applicableGrade 1-2 hyperglycaemia
Study
n = 41
Outcome group
Adverse events · Endocrine and hormones
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Measurements
Patients with grade 1-2 hyperglycaemia
41%
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Patients with grade 1-2 hyperglycaemia
17 patients
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Source sentences
Summary
The most common grade 1-2 adverse events with a suspected association with long-acting pasireotide monotherapy were diarrhoea (15 [37%] of 41), hyperglycaemia (17 [41%]), and weight loss (8 [20%]);
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409903
06HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, suspected pasireotide-related grade 1-2 weight loss occurred in eight patients (20%).
In plain wordsIn advanced lung or thymic carcinoids, 20% receiving pasireotide alone experienced suspected treatment-related grade 1-2 weight loss.
Peptide
Pasireotide
Outcome
Not applicableGrade 1-2 weight loss
Study
n = 41
Outcome group
Adverse events · Metabolic and weight
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Measurements
Patients with grade 1-2 weight loss
20%
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Patients with grade 1-2 weight loss
8 patients
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Source sentences
Summary
The most common grade 1-2 adverse events with a suspected association with long-acting pasireotide monotherapy were diarrhoea (15 [37%] of 41), hyperglycaemia (17 [41%]), and weight loss (8 [20%]);
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409904
07HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, suspected pasireotide-related grade 3-4 increased γ-glutamyltransferase occurred in four of 41 patients (10%).
In plain wordsIn advanced lung or thymic carcinoids, 10% receiving pasireotide alone experienced suspected treatment-related grade 3-4 increases in a liver enzyme.
Peptide
Pasireotide
Outcome
Not applicableGrade 3-4 increased gamma-glutamyltransferase
Study
n = 41
Outcome group
Adverse events · Liver
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Measurements
Patients with grade 3-4 gamma-glutamyltransferase increased
10%
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Patients with grade 3-4 gamma-glutamyltransferase increased
4 patients
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Source sentences
Summary
The most common grade 3-4 adverse events with a suspected association with long-acting pasireotide monotherapy were γ-glutamyltransferase increased (four [10%] of 41 patients), diarrhoea (three [7%]), and hyperglycaemia (three [7%]);
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409905
08HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, suspected pasireotide-related grade 3-4 diarrhoea occurred in three patients (7%).
In plain wordsIn advanced lung or thymic carcinoids, 7% receiving pasireotide alone experienced suspected treatment-related grade 3-4 diarrhoea.
Peptide
Pasireotide
Outcome
Not applicableGrade 3-4 diarrhoea
Study
n = 41
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Measurements
Patients with grade 3-4 diarrhoea
7%
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Patients with grade 3-4 diarrhoea
3 patients
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Source sentences
Summary
The most common grade 3-4 adverse events with a suspected association with long-acting pasireotide monotherapy were γ-glutamyltransferase increased (four [10%] of 41 patients), diarrhoea (three [7%]), and hyperglycaemia (three [7%]);
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409906
09HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, suspected pasireotide-related grade 3-4 hyperglycaemia occurred in three patients (7%).
In plain wordsIn advanced lung or thymic carcinoids, 7% receiving pasireotide alone experienced suspected treatment-related grade 3-4 high blood glucose.
Peptide
Pasireotide
Outcome
Not applicableGrade 3-4 hyperglycaemia
Study
n = 41
Outcome group
Adverse events · Endocrine and hormones
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Measurements
Patients with grade 3-4 hyperglycaemia
7%
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Patients with grade 3-4 hyperglycaemia
3 patients
suspected treatment-related, pasireotide monotherapy group, of 41 patients
Source sentences
Summary
The most common grade 3-4 adverse events with a suspected association with long-acting pasireotide monotherapy were γ-glutamyltransferase increased (four [10%] of 41 patients), diarrhoea (three [7%]), and hyperglycaemia (three [7%]);
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409907
10HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, two of 41 pasireotide-monotherapy patients died during core treatment or within 56 days after last exposure (5%).
In plain wordsIn advanced lung or thymic carcinoids, two pasireotide-monotherapy patients died during core treatment or within 56 days after last exposure.
Peptide
Pasireotide
Outcome
Not applicableDeaths
Study
n = 41
Outcome group
Mortality · Whole body
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Measurements
Patients with deaths during core treatment or within 56 days of last exposure
5%
pasireotide monotherapy group, of 41 patients
Patients with deaths during core treatment or within 56 days of last exposure
2 patients
pasireotide monotherapy group, of 41 patients
Source sentences
Summary
11 patients died during the core 12-month treatment phase or up to 56 days after the last study treatment exposure date: two (5%) of 41 in the long-acting pasireotide group,
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409908
11HumanNon-randomized trialSafety outcome
In advanced lung or thymic carcinoids, no deaths were suspected to relate to pasireotide treatment.
In plain wordsIn advanced lung or thymic carcinoids, no deaths were suspected to relate to pasireotide treatment.
Peptide
Pasireotide
Outcome
Not applicableSuspected treatment-related deaths
Study
n = 41
Outcome group
Mortality · Whole body
Studied dose
60 mg every 28 days · intramuscular · 12-month core treatment periodAs given in this study (human).
Source sentences
Summary
No deaths were suspected to be related to long-acting pasireotide treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus,
Summary · context
patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days)
Report a problemFND-2907409909

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT01563354

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

Novartis Pharmaceuticalsn = 12416 Aug 2013 to 10 Feb 2020

Neuroendocrine Carcinoma of the Lung and Thymus

Trial page ClinicalTrials.govUpdated 2 Apr 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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