Lutathera 370 MBq/mL solution for infusion
Sponsors
Karolinska University Hospital, Advanced Accelerator Applications, CHRU De Nancy, Institut Regional Du Cancer De Montpellier, Swiss Group for Clinical Cancer Research
Conditions
Gastroenteropancreatic neuroendocrine tumor (GEP-NET)Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adultsLocoregionally restricted (stage III) small intestinal neuroendocrine neoplasms (SI-NEN)Metastatic castration-resistant prostate cancerNeuroblastomaNeuroendocrine tumorNeuroendocrine tumors of midgut originPatients with somatostatin receptor positive
Phase 1
A Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTA0-Tyr3-Octreotate in Children with Refractory or Recurrent Neuroblastoma expressing somatostatin receptors
RecruitingCTIS2024-515552-21-00
Start: 2023-04-17Target: 18Updated: 2025-10-08
Randomized Interval Assessment trial of Lu177-Dotatate every 8 versus every 16 weeks in slowly progressive G1-2 advanced midgut neuroendocrine tumors (NETs) to Lower TOxicity.
RecruitingCTIS2024-517921-14-00
Start: 2025-05-07Target: 158Updated: 2025-03-20
Phase 2
A phase II trial of 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma
LuDO-N
SuspendedCTIS2023-503684-42-00
Start: 2021-01-12Target: 31Updated: 2024-10-18
A PROSPECTIVE RANDOMIZED PHASE II STUDY TO ASSESS THE SCHEMAS OF RETREATMENT WITH LUTATHERA® ([177LU]LU-DOTA-TATE) IN PATIENTS WITH NEW PROGRESSION OF INTESTINAL WELL-DIFFERENTIATED NEUROENDOCRINE TUMOR
RecruitingCTIS2024-511001-28-00
Start: 2021-12-13Target: 176Updated: 2025-05-09
Evaluation of the addition of Everolimus to 177Lu-DOTATATE in the treatment of grades 2 and 3 refractory meningioma: a phase IIb clinical trial
RecruitingCTIS2023-508400-38-00
Start: 2024-11-29Target: 28Updated: 2025-09-08
A multicenter open-label study to evaluate safety and dosimetry of Lutathera in adolescent patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas
Active, not recruitingCTIS2023-507444-37-00
Start: 2021-04-21Target: 5Updated: 2024-08-06
Single-arm open-label phase II study in children and adolescents of 177Lu-DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptor (SSTR) (LuPARPed).
Active, not recruitingCTIS2024-512613-40-00
Start: 2024-08-28Target: 27Updated: 2025-01-20
"Imaging with 68Ga-DOTA-peptides and peptide receptor radionuclide therapy with 177Lu-DOTA-peptides of gastroenteropancreatic neuroendocrine tumors: interest of intra-arterial hepatic infusion in patients with dominant liver metastases" "LUTARTERIAL"
RecruitingCTIS2024-514785-39-00
Start: 2021-09-24Target: 23Updated: 2024-11-04
EORTC 2334-BTG: [177Lu]Lu-DOTATATE for recurrent MENingioma (LUMEN-1): a randomized phase II study
RecruitingCTIS2024-513443-93-00
Start: 2025-03-10Target: 61Updated: 2026-01-16
SAKK 08/23: Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial
RecruitingCTIS2024-512132-29-00
Start: 2025-08-06Target: 100Updated: 2025-05-22
Phase 3
A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Lutathera in patients with Grade 2 and Grade 3 advanced GEP-NET (NETTER-2)
Active, not recruitingCTIS2023-507443-10-00
Start: 2019-11-04Target: 90Updated: 2025-11-19
A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients newly diagnosed with Grade 1 and Grade 2 (Ki-67 <10%) advanced GEP-NET with high disease burden (NETTER-3)
RecruitingCTIS2024-518325-15-00
Start: 2025-09-08Target: 99Updated: 2025-12-09
Efficacy and safety of adjuvant peptide receptor radionuclide therapy after curative surgery of locoregional limited small intestine neuroendocrine neoplasia – a multi-center, prospective, open-label, two-arm parallel group, randomized, controlled, phase III study
Not yet recruitingCTIS2024-518236-36-00
Target: 160Updated: 2025-09-19