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Arginine-Lysine solution for infusion

DRUG4 trials

Sponsors

Grupo Espanol De Tumores Neuroendocrinos, ITM Solucin GmbH

Conditions

Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (GEP-NET)Neuroendocrine tumours of gastroenteric or pancreatic originPatients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy.Pediatric patients two years of age and above with somatostatin receptor positive (SSTR-positive) solid tumors or lymphomaSomatostatin receptor-positive (SSTR+)Well-differentiated Aggressive Grade 2 and Grade 3recurrent/refractory to at least one prior line of therapy

Phase 1

Phase 3

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
RecruitingCTIS2022-502154-13-00
Grupo Espanol De Tumores NeuroendocrinosPatients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy.
Start: 2023-10-27Target: 135Updated: 2025-07-17
A prospective, randomised, Controlled, Open-label, Multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Active, not recruitingCTIS2023-510444-21-00
ITM Solucin GmbHNeuroendocrine tumours of gastroenteric or pancreatic origin
Start: 2017-11-24Target: 268Updated: 2025-11-24
A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor‑positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin
Active, not recruitingCTIS2024-510812-64-00
ITM Solucin GmbHNeuroendocrine Tumors of GastroEnteric or Pancreatic Origin (GEP-NET), Somatostatin receptor-positive (SSTR+), Well-differentiated Aggressive Grade 2 and Grade 3
Start: 2021-09-30Target: 153Updated: 2025-11-12

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