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. The LEVEL trial

Conditions

Patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy.

Brief summary

The primary endpoint for the LEVEL Trial is the 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

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 Viñuales M, Ansquer C, Baudin E, Lepage C, Del Olmo-García M, Ruffinelli JC, Beron A, Haissaguerre M, Deshayes E, Taïeb D, Baldari S, Sansovini M, Cingarlini S, Filice A, Panzuto F, Álvarez-Álvarez R, Lousberg L, Aboubakar Nana F, Hernando J, García-Álvarez A, García-Burillo A, Villacampa G, Vandamme T, Fazio N, Durand A.

2025-04-042 citations

10.1186/s12885-025-13941-3

Interventions

DRUGAfinitor 10 mg tablets

DRUGArginine-Lysine solution for infusion

DRUG177Lu-Edotreotide

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint for the LEVEL Trial is the 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	—

Countries

Belgium, France, Italy, Spain

Outcome results

None listed