RecruitingPhase 3NCT05918302

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

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.

Sponsor

Grupo Espanol de Tumores Neuroendocrinos

Enrollment

120 participants

Start Date

Oct 27, 2023

Study Type

INTERVENTIONAL

Conditions

Neuroendocrine Tumors Lung Neuroendocrine Neoplasm Thymus Neoplasms

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for a rare type of slow-growing lung or thymus cancer called a neuroendocrine tumor (NET) — specifically tumors that have spread or cannot be surgically removed. One group will receive targeted radiation therapy (using a radioactive substance that seeks out tumor cells), while the other receives the oral drug everolimus, which slows tumor growth by blocking a key growth signal. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with a well or moderately differentiated neuroendocrine tumor originating in the lung or thymus that is metastatic or cannot be removed with surgery - Your tumors show uptake on a specialized imaging scan (somatostatin receptor imaging, or SSTR scan) - Your tumors have shown evidence of growth in the past 12 months - Your tumor was confirmed by biopsy with the correct pathological features **You may NOT be eligible if:** - Your tumors do not show uptake on SSTR imaging - Your disease has not shown documented progression in the past year - You do not meet organ function requirements - You have certain other serious medical conditions that make these treatments unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-edotreotide

6 cycles of 7.5 ± 0.7 Giga becquerel (GBq) 177Lu-edotreotide

DRUGEverolimus

10 mg orally once daily (QD)

Locations(27)

Antwerp University Hospital (UZA)

Edegem, Edegem, Belgium

UCL Saint-Luc

Brussels, Belgium

CHU Liège

Liège, Belgium

Hospital Center University Dijon Bourgogne (CHU Bourgogne)

Dijon, Dijon, France

Centre Hospitalier Universitaire (CHU) Bordeux

Bourdeaux, France

Lille University Hospital

Lille, France

Hôpital Edouard Herriot, Lyon

Lyon, France

Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France

Marseille, France

Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier

Montpellier, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

I. Gustave Roussy, Paris

Paris, France

Azienda USL IRCCS Di Reggio Emilia

Reggio Emilia, Reggio Emilia, Italy

AOU Consorziale Policlinico di Bari - CROB Referrall Cancer Center of Basilicata

Bari, Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola

Meldola, Italy

Istituto Europeo di Oncologia - Milano

Milan, Italy

Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.

Roma, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Hospital Universitario Virgen del Rocío

Seville, Andalusia, Spain

ICO Institut Català d'Oncologia L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Complexo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario Ramón y Cajal, Madrid

Madrid, Madrid, Spain

Fundación Jiménez Díaz University Hospital

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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