Clinical trial · Interventional
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
NCT01563354CI-TRIAL-00051031LUNAcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma of the Lung and Thymus | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Pasireotide LAR | Drug | — | UNRESOLVED |
| Pasireotide LAR and Everolimus Combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pasireotide LAR
- description
- 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
- interventionNames
- Drug: Pasireotide LAR
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
- interventionNames
- Drug: Everolimus
- type
- EXPERIMENTAL
- label
- Pasireotide LAR and Everolimus Combination
- description
- Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDFerolla 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 29074099