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

NCT05918302 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

177Lu-edotreotide

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

DRUG

Everolimus

10 mg orally once daily (QD)

Sponsors & Collaborators

  • ITM Oncologics GmbH

    collaborator INDUSTRY

  • MFAR

    collaborator OTHER

  • Grupo Espanol de Tumores Neuroendocrinos

    lead OTHER

Principal Investigators

  • Jaume Capdevila, M.D. Ph.D. · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2029-03-31
Completion
2029-10-31

Countries

  • Belgium
  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918302 on ClinicalTrials.gov