Study

EORTC-2361-GUCG

Phase II trial evaluating the efficacy of 177Lutetium-PSMA-617 treatment in patients with metastatic clear cell Renal Carcinoma Cell with progressive disease on first-line or second-line systemic treatment (RENALUT)

Trial Status

Recruiting

Dates

Date of activation: 25-Feb-2026

Data management at EORTC

Yes

Design

Phase 2

Targeted Sample size

EORTC Groups: 56 - All Groups: 56

Treatment

Drug
lutetium (177lu) vipivotide tetraxetan

Study Staff

  • Justine Bobinnec (Study Coordinator), EORTC Liaison Office France, Paris
  • Emmanuel Seront (Study Coordinator), Cliniques Universitaires Saint-Luc, Brussels
  • Laurence Albiges (Study Co-Coordinator), Gustave Roussy, VILLEJUIF CEDEX
  • Karolien Goffin (Study Co-Coordinator), U.Z. Leuven - Campus Gasthuisberg, Leuven
  • Mehdi Bsilat (Y-ECI Coordinator), CHU Montpellier-Hopital Arnaud De Villeneuve, MONTPELLIER CEDEX 5
  • Christian Alfano (Project Manager), EORTC Headquarters, Brussels
  • Bert Dhondt (Clinical Research Physician), EORTC Headquarters, Brussels
  • Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
  • Jedelyn Cabrieto (Statistician), EORTC Headquarters, Brussels
  • Cedric Mallien (TR Scientist), EORTC Headquarters, Brussels
  • Joanna Krzystyniak (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Sofiane Bendiab (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Liliane Henkes (Senior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Arnaud Poncin (Data Manager), EORTC Headquarters, Brussels
  • Shani De Coster (Study Designer), EORTC Headquarters, Brussels
  • Maarten Spruyt (Imaging DM), EORTC Headquarters, Brussels
  • Bart Meulemans (Clinical Data Expert), EORTC Headquarters, Brussels
  • Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Kevin Pilger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Daniel Urosa (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Lucy Sepulveda (Admin. assistant RA), EORTC Headquarters, Brussels
  • Hanne Belien (Clinical Operations Assistant), EORTC Headquarters, Brussels

Type of cancer

  • Renal

Participating groups

  • EORTC Genito-Urinary Cancers Group

Recruiting centers

  • Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France)
  • Gustave Roussy (VILLEJUIF CEDEX, France)

Centers to be activated

  • APHP - Hop. Univ. Henri Mondor (Creteil, France)
  • C.H.U. Sart-Tilman (Liege, Belgium)
  • CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
  • Hospital Universitario 12 De Octubre (Madrid, Spain)
  • Hospital Universitario Ramon y Cajal (Madrid, Spain)
  • Institut Jules Bordet (Anderlecht, Belgium)
  • Universitair Ziekenhuis Gent (Gent, Belgium)

Protocol summary

NCT number

NCT06783348