Actively Recruiting
Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
Led by Grupo Espanol de Tumores Neuroendocrinos · Updated on 2026-05-12
170
Participants Needed
27
Research Sites
309 weeks
Total Duration
On this page
Sponsors
G
Grupo Espanol de Tumores Neuroendocrinos
Lead Sponsor
I
ITM Oncologics GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.
CONDITIONS
Official Title
Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older.
- Histologically confirmed metastatic or locally advanced unresectable well or moderately differentiated neuroendocrine tumors of lung or thymus origin.
- Tumors must have appropriate pathological features based on WHO 2015 classification.
- Tumors must show high expression of somatostatin receptors on imaging.
- Evidence of disease progression within the last 12 months.
- Patients may be treatment-na�efve or have had up to two prior systemic therapies.
- Radiographically documented measurable metastatic or locally advanced disease at baseline.
- Archival or new tumor tissue sample available for central laboratory.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function based on specified laboratory criteria.
- Female patients must have negative pregnancy test and agree to use effective birth control during and 6 months after treatment.
- Female patients must agree not to breastfeed during study and for 6 months after.
- Male patients must agree not to donate sperm during study and for 6 months after.
- Male patients with pregnant or breastfeeding partners must agree to use condoms or abstinence during study and for 6 months after.
- Agreement not to participate in another interventional study during treatment.
You will not qualify if you...
- Inability to swallow tablets.
- Poorly differentiated or high-grade neuroendocrine carcinoma or mixed tumors.
- Brain metastases unless stable for more than 12 weeks without symptoms.
- Ongoing significant toxicity from prior treatments.
- Recent diagnosis or ongoing treatment of another cancer within 12 months.
- Active hepatitis B or C infection, or HIV infection.
- Receipt of live vaccines within 4 weeks before study treatment.
- Recent history of stroke, unstable angina, myocardial infarction, or severe heart failure within 6 months.
- Prior peptide receptor radionuclide therapy or mTOR inhibitors within 6 months.
- Radiotherapy or major surgery within 12 weeks before study treatment.
- Recent chemotherapy, biologics, investigational agents, or immunotherapy not completed 4 weeks before treatment.
- Known hypersensitivity to study drugs or their components.
- Urinary incontinence preventing safe drug administration.
- Other medical conditions that may impair ability to tolerate treatment or follow-up.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 27 locations
1
Antwerp University Hospital (UZA)
Edegem, Edegem, Belgium, 2650
Actively Recruiting
2
UCL Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
3
CHU Liège
Liège, Belgium, 4000
Actively Recruiting
4
Hospital Center University Dijon Bourgogne (CHU Bourgogne)
Dijon, Dijon, France, 21079
Actively Recruiting
5
Centre Hospitalier Universitaire (CHU) Bordeux
Bourdeaux, France, 33000
Actively Recruiting
6
Lille University Hospital
Lille, France, 59000
Actively Recruiting
7
Hôpital Edouard Herriot, Lyon
Lyon, France, 69003
Actively Recruiting
8
Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France
Marseille, France, 13005
Actively Recruiting
9
Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier
Montpellier, France, 34090
Actively Recruiting
10
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44000
Actively Recruiting
11
I. Gustave Roussy, Paris
Paris, France, 94805
Actively Recruiting
12
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, Reggio Emilia, Italy, 42123
Actively Recruiting
13
AOU Consorziale Policlinico di Bari - CROB Referrall Cancer Center of Basilicata
Bari, Italy, 70124
Actively Recruiting
14
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola
Meldola, Italy, 47014
Actively Recruiting
15
Istituto Europeo di Oncologia - Milano
Milan, Italy, 20141
Actively Recruiting
16
Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.
Roma, Italy, 00189
Not Yet Recruiting
17
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Actively Recruiting
18
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain, 41013
Actively Recruiting
19
ICO Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
20
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain, 28042
Actively Recruiting
21
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
22
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Madrid, Spain, 28034
Actively Recruiting
23
Fundación Jiménez Díaz University Hospital
Madrid, Madrid, Spain, 28040
Actively Recruiting
24
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
25
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
26
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
27
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
F
Federico Nepote
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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