Neuroendocrine TumorsPhase 3LEVELNCT05918302

Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

A Phase 3 study testing 177Lu-edotreotide and Everolimus in people with Neuroendocrine Tumors and Lung Neuroendocrine Neoplasm, run by Grupo Espanol de Tumores Neuroendocrinos at 27 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuroendocrine Tumors, Lung Neuroendocrine Neoplasm, Thymus Neoplasms
What is being tested?: 177Lu-edotreotide and Everolimus
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 27 sitesin 4 countries
Study dates: 27 Oct 2023to Oct 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
Patients ≥ 18 years of age.
Patients who have histologically confirmed metastatic or locally advanced unresectable well/moderately differentiated; World Health Organization (WHO]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning.
Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index.
In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging.
Lesions must have shown radiological evidence of disease progression in the 12 months prior to inclusion in the study. Patients who were receiving systemic anticancer therapy, progression should be documented on therapy or after stopping therapy due to adverse events or other reasons. Patients without prior therapy, documentation of progression is also mandatory to watch and wait strategy or during the follow up after surgery.

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Patients may be included in first-line therapy (systemic treatment naïve) or may have experienced progression on somatostatin analogues or additional systemic treatments, which may include but not limited to chemotherapy, targeted agents or immunotherapy (maximum of 2 prior systemic anti-tumor treatments).
Note: Somatostatin analogues for patients with functioning tumors are allowed.
Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1.
An archival tumor tissue sample should be available for submission to the central laboratory prior to study treatment (36 months). If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided if feasible.
Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria:
Neutrophil count (ANC) ≥ 1,500/mm^3
Platelet count ≥ 75 × 10^9/L
Hemoglobin ≥ 8 g/dL
Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases
Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases
Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%) for the duration of the study treatment and for 6 months after the final dose of study treatment.
Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.
Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.
Male patients with a pregnant or breastfeeding partner(s) must agree to abstinence or use a condom for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for at least 6 months after the final study drug administration.
Subject agrees not to participate in another interventional study while on treatment in the present study.

Who cannot join

Patients who are not able to swallow tablets.
Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible.
Patients with brain mets unless stable on treatment for > 12 weeks and with no evidence of raised intracranial pressure or mass effect.
Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA [qualitative] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).

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Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment.
Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose.
Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.
Prior peptide receptor radionuclide therapy (PRRT) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.); or hepatic radio-embolization (within 6 months prior to first dose of study treatment).
Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug.
Patients who have had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug.
Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus.
Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS).
Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion.
Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.

Trial locations and contacts

27 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Federico Nepote contact

+34934344412

investigacion@mfar.net

Country

City, postcode or hospital

Sites recruiting now only

27 sites in 4 countries

Spain10 sites, 10 recruiting

Hospital Universitari Vall d'Hebron
Barcelona, 08035
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
ICO Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
A responsible person Designated by the sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Madrid, 28034
a responsible person Designated by the sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting
Fundación Jiménez Díaz University Hospital
Madrid, Madrid, 28040
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
A Responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
A responsible person Designated by the sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, 28042
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Hospital Universitario Virgen del Rocío
Seville, Andalusia, 41013
A responsible person Designated by the sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
A responsible person Designated by the sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting

Other trials in Spain

France8 sites, 8 recruiting

Centre Hospitalier Universitaire (CHU) Bordeux
Bourdeaux, 33000
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Hospital Center University Dijon Bourgogne (CHU Bourgogne)
Dijon, Dijon, 21079
A responsible person Designed by the sponsor, 934344412, investigacion@mfar.net
A Principal Investigator Designed by the sponsor, M.D.
Recruiting
Lille University Hospital
Lille, 59000
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Hôpital Edouard Herriot, Lyon
Lyon, 69003
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting
Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France
Marseille, 13005
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier
Montpellier, 34090
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Centre Hospitalier Universitaire de Nantes
Nantes, 44000
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting
I. Gustave Roussy, Paris
Paris, 94805
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Recruiting

Other trials in France

Italy6 sites, 6 recruiting

AOU Consorziale Policlinico di Bari - CROB Referrall Cancer Center of Basilicata
Bari, 70124
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola
Meldola, 47014
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Istituto Europeo di Oncologia - Milano
Milan, 20141
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, Reggio Emilia, 42123
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.
Roma, 00189
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.
Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting

Other trials in Italy

Belgium3 sites, 3 recruiting

UCL Saint-Luc
Brussels, 1200
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
Antwerp University Hospital (UZA)
Edegem, Edegem, 2650
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting
CHU Liège
Liège, 4000
A responsible person Designated by the Sponsor, +34934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.
Recruiting

Other trials in Belgium

About this study

Official title: Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

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.

Read the detailed description

The LEVEL Trial is a randomized, prospective, international, open-label, phase III study comparing everolimus and 177Lu-edotreotide in advanced somatostatin receptor positive (SSTR+) lung and thymic well differentiated neuroendocrine tumors with high expression of somatostatin receptors confirmed by positron emission tomography somatostatin receptor imaging.

In the investigator's opinion, patients recruited into the trial must be eligible to receive everolimus. Patients with both functional and nonfunctional lung and thymus neuroendocrine tumors (NETs) will be included in this trial. In total, 170 patients will be randomized in a 3:2 proportion to either experimental or control arms, respectively.

Randomization will be stratified according to prior medical therapy (tumor treatment-naïve [patients who have not received any prior systemic anticancer therapy] versus non-treatment- naïve [patients who have received one or two prior line of systemic anticancer therapy, including somatostatin analogs (SSAs) as anti-tumor treatment]) and histological differentiation (typical versus atypical / well versus moderately differentiated). Stratification according to the functional status is not foreseen considering the poor predictive and prognostic relevance of this criteria on PRRT in the literature.

Diagnosis of progression and tumor burden will be established based on radiological information from morphological imaging (magnetic resonance imaging [MRI] and/or computed tomography [CT]) according to RECIST v1.1. Tumors assessments will be scheduled every 12 ± 2 weeks from randomization (the first scan will be performed after Cycle 2 for the 177Lu-edotreotide until radiologically confirmed progression of the disease, initiation of new subsequent anticancer therapy, or death (whichever comes first). The scanning modality and protocol should be consistent with the baseline scan. Diagnosis of RECIST v1.1 progression will be made by the local investigator. The confirmatory scans should be performed preferably at the next scheduled imaging visit and no less than 4 weeks after the prior assessment of progression (PD) (in the absence of clinically significant deterioration). Additional MRI/CT scans may be performed at any other time if, in the investigator's clinical judgment, PD is suspected. For equivocal findings of progression, treatment may continue until the next scheduled assessment.

In both arms, for a given patient, trial treatment dosing should be discontinued if there is evidence of RECIST v1.1 progression, in case of persistent toxicities or if the patient withdraws consent to continue with treatment. In all cases, if possible, all other protocol scheduled assessments should be continued until the end of the long-term follow-up period, unless the patient explicitly withdraws consent to all trial procedures and follow-up.

Conditions: Neuroendocrine Tumors, Lung Neuroendocrine Neoplasm, Thymus Neoplasms
Being tested: 177Lu-edotreotide, Everolimus
Medical subject headings: Neuroendocrine Tumors, Thymus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

177Lu-edotreotideDrug
6 cycles of 7.5 ± 0.7 Giga becquerel (GBq) 177Lu-edotreotide
EverolimusDrug
10 mg orally once daily (QD)

Study groups in NCT05918302
Study group	Role	What they receive
Experimental arm	Experimental	Treatment with 6 cycles of 7.5 ± 0.7 GBq 177Lu-edotreotide. The prescribed treatment administration is as follows: a 6 (±2) weeks interval between cycles 1 and 2 followed by all remaining cycles (3-6) given 8 (± 1) weeks after the previous cycle), where possible, or until disease progression, intolerable toxicity or death, whichever occurs first. Receives: Drug: 177Lu-edotreotide
Control arm	Active comparator	Everolimus 10 mg orally once daily (QD) until disease progression or intolerable toxicity or death, whichever occurs first. Receives: Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free survival (PFS)
Progression-free survival (PFS) defined as the time from the date of randomization to the date of first documentation of disease progression according to RECIST 1.1 by investigator-assessment or death due to any cause, whichever occurs first. In the primary analysis, PFS will be censored at the date of the last adequate tumor assessment if no PFS event is observed prior to the analysis cut-off date.
Measured: Throughout the study period, approximately 3 years per patient

Secondary outcomes (5)

Objective response rate (ORR)
Assessed by the investigator through imaging follow-up (CT scan/MRI) using RECIST v1.1. This will be considered as the percentage/proportion of randomized patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period.
Measured: Throughout the study period, approximately 3 years per patient
Disease control rate (DCR)
Percentage/proportion of randomized patients with complete response (CR) or partial response (PR), according to ORR definition for the trial, or maintained stable disease (SD) as their overall best response, assessed by imaging follow-up (CT scan/MRI) and RECIST v1.1 criteria. Stable disease should be maintained for at least 4 months to be considered as a DCR event.
Measured: Throughout the study period, approximately 3 years per patient
Duration of response (DoR)
Time from first confirmed response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.
Measured: Throughout the study period, approximately 3 years per patient
Overall Survival (OS)
Defined as the time elapsed from randomization until death from any cause. We will assess the median OS, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Measured: Throughout the study period, approximately 3 years per patient, at each visit. Long-term follow-up to be performed at least every 6 months.
Patient reported quality of life
Assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) C30 (EORTC QLQ-C30), version 3 and lung cancer specific extension module LC-13. This are structural questionnaires self completed by the patient and which will give a numerical value to their own perception of quality of life. The scores obtained are standardized and a score between 0 (worst quality of life) and 100 (better quality of life).
Measured: Throughout the study period, approximately 3 years per patient. Assessed every 12 weeks from randomization to progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 2023Oct 2029

First posted26 Jun 2023
Study start27 Oct 2023
Primary completionMar 2029 (estimated)
Study completionOct 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 170 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05918302
Sponsor's protocol ID: GETNE-T2217
Other IDs: 2022-502154-13-00
Acronym: LEVEL
Status last verified: Sep 2025
First submitted: 6 Mar 2023
Last updated: 12 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Analyzed compiled results will be publicly available to support the conclusion from the study. Individual data will be available upon reasonable request.

Publications

Capdevila J, Pubul V, Anido U, Walter T, Molina-Cerrillo J, Alonso-Gordoa T, Garcia-Carbonero R, San-Roman-Gil M, Llana B, Jimenez-Fonseca P, Benavent Vinuales M, Ansquer C, Baudin E, Lepage C, Del Olmo-Garcia M, Ruffinelli JC, Beron A, Haissaguerre M, Deshayes E, Taieb D, Baldari S, Sansovini M, Cingarlini S, Filice A, Panzuto F, Alvarez-Alvarez R, Lousberg L, Aboubakar Nana F, Hernando J, Garcia-Alvarez A, Garcia-Burillo A, Villacampa G, Vandamme T, Fazio N, Durand A. A Randomized clinical trial evaluating the impact on survival and quality of life of 177Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217). BMC Cancer. 2025 Apr 4;25(1):613. doi: 10.1186/s12885-025-13941-3.
PubMed 40186126

Interested in taking part?

Federico Nepote

+34934344412

investigacion@mfar.net

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
ClinicalTrials.gov ID: NCT05918302
Acronym / sponsor ID: LEVEL / GETNE-T2217
Conditions: Neuroendocrine Tumors, Lung Neuroendocrine Neoplasm, Thymus Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 170 participants (estimated)
Lead sponsor: Grupo Espanol de Tumores NeuroendocrinosUniversity, hospital or other
Collaborators: Lumara Bio Oncologics GmbH, MFAR
Study start: 27 Oct 2023 (actual)
Primary completion: Mar 2029 (estimated)
Study completion: Oct 2029 (estimated)
First posted: 26 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental arm	Experimental	Drug: 177Lu-edotreotideTreatment with 6 cycles of 7.5 ± 0.7 GBq 177Lu-edotreotide. The prescribed treatment administration is as follows: a 6 (±2) weeks interval between cycles 1 and 2 followed by all remaining cycles (3-6) given 8 (± 1) weeks after the previous cycle), where possible, or until disease progression, intolerable toxicity or death, whichever occurs first.
Control arm	Active comparator	Drug: EverolimusEverolimus 10 mg orally once daily (QD) until disease progression or intolerable toxicity or death, whichever occurs first.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
Patients ≥ 18 years of age.
Patients who have histologically confirmed metastatic or locally advanced unresectable well/moderately differentiated; World Health Organization (WHO]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning.
Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index.
In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging.

Key exclusion criteria (16 listed)

Patients who are not able to swallow tablets.
Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible.
Patients with brain mets unless stable on treatment for > 12 weeks and with no evidence of raised intracranial pressure or mass effect.
Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
177Lu-edotreotide6 cycles of 7.5 ± 0.7 Giga becquerel (GBq) 177Lu-edotreotide	Drug	Experimental arm
Everolimus10 mg orally once daily (QD)	Drug	Control arm

Primary outcome

Progression-free survival (PFS)
Time frame: Throughout the study period, approximately 3 years per patient
Progression-free survival (PFS) defined as the time from the date of randomization to the date of first documentation of disease progression according to RECIST 1.1 by investigator-assessment or death due to any cause, whichever occurs first. In the primary analysis, PFS will be censored at the date of the last adequate tumor assessment if no PFS event is observed prior to the analysis cut-off date.

5 secondary outcomes

Objective response rate (ORR)
Time frame: Throughout the study period, approximately 3 years per patient
Disease control rate (DCR)
Time frame: Throughout the study period, approximately 3 years per patient
Duration of response (DoR)
Time frame: Throughout the study period, approximately 3 years per patient
Overall Survival (OS)
Time frame: Throughout the study period, approximately 3 years per patient, at each visit. Long-term follow-up to be performed at least every 6 months.
Patient reported quality of life
Time frame: Throughout the study period, approximately 3 years per patient. Assessed every 12 weeks from randomization to progression

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Derived from this study: PubMed 40186126Capdevila J, Pubul V, Anido U, Walter T, Molina-Cerrillo J, Alonso-Gordoa T, Garcia-Carbonero R, San-Roman-Gil M, Llana B, Jimenez-Fonseca P, Benavent Vinuales M, Ansquer C, Baudin E, Lepage C, Del Olmo-Garcia M, Ruffinelli JC, Beron A, Haissaguerre M, Deshayes E, Taieb D, Baldari S, Sansovini M, Cingarlini S, Filice A, Panzuto F, Alvarez-Alvarez R, Lousberg L, Aboubakar Nana F, Hernando J, Garcia-Alvarez A, Garcia-Burillo A, Villacampa G, Vandamme T, Fazio N, Durand A. A Randomized clinical trial evaluating the impact on survival and quality of life of 177Lutetium[Lu]-edotreotide versus everolimus in patients with neuroendocrine tumors of the lung and thymus: the LEVEL study (GETNE T-2217). BMC Cancer. 2025 Apr 4;25(1):613. doi: 10.1186/s12885-025-13941-3.
Individual participant dataSharing planned: No. Analyzed compiled results will be publicly available to support the conclusion from the study. Individual data will be available upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Federico Nepote contact

+34934344412

investigacion@mfar.net

Jaume Capdevila, M.D. Ph.D. study chair

Hospital Vall d'Hebron

27 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain, France, Italy, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Federico Nepote (+34934344412, investigacion@mfar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Throughout the study period, approximately 3 years per patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05918302, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.