COMPETE trial Archives

Tag: COMPETE trial

COMPETE is led as an international pivotal multi-center phase III clinical trial evaluating the efficacy and safety of (no-carrier-added) n.c.a.177Lu-Edotreotide (Solucin®) and the trial is comparing it to Everolimus (Afinitor). The trial runs until Dec 2020. The enrolment requires patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The primary endpoint is progression-free survival (PFS). The study will be conducted predominantly in Europe, North America, South Africa and Australia. The first patient to be enrolled and treated was in Australia. The clinical trial document (see references below) indicates it’s for non-functional GI tumours but for non-functional and functional pNETs. The list of locations can also be found in the clinical trial document. The usual inclusion/exclusion rules apply but the most notable would appear to be an exclusion for those with prior exposure to any PRRT or mTor inhibitor such as Everolimus (Afinitor).

29 Jan 2025

By Ronny Allan

4 Comments

Phase 3 Clinical Trial of PRRT ITM11 177Lu-Edotreotide – COMPETE for GEPNETs

Clinical Trials and Research68Ga edotreotide (TOCscan®), Advanced neuroendocrine cancer, Afinitor, COMPETE trial, Edotreotide, EndolucinBeta, Everolimus, Gastro-entero-pancreatic neuroendocrine tumour (GEP-NET), Neuroendocrine cancer, Neuroendocrine tumour (NET), No-Carrier-Added Lutetium-177 (n.c.a. Lu177), Octreotide, Solucin ®, Somatostatin analogues, Somatostatin receptors (SSTR), TOCscan®

Update - 13th November 2025. ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) Garching / Munich, Germany, November 13, 2025 - ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal…

08 May 2017

By Ronny Allan

45 Comments

All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

Clinical Trials and Research, Treatment177Lu OPS 201, 177Lu-Edotreotide (Solucin®), 177Lu-PSMA-R2, 68Ga-PSMA-R2, Advanced neuroendocrine cancer, Carcinoid tumour, COMPETE trial, Ga68 PET/CT, Incurable cancer, Lanreotide, Lu-177, Lutathera, LUTIA clinical trial, Metastatic Neuroendocrine Cancer, NETSPOT, NETTER-1, NETTER-2, Neuroendocrine cancer, Neuroendocrine tumour (NET), Octreotide, Paraganglioma, Pheochromocytoma, PRCRT, Prostate Cancer, PRRT, Quality of LIfe (QoL), Radiopeptide, SomaKit TOC, Somatostatin analogues, Somatostatin receptors (SSTR), SPECT, Theranostics, Yttrium 90 (Y90)

Updated 11th March 2026 This update authored by many top names in the PRRT/NET world is extremely useful to bring you up to date in 2026 Lisa Bodei, Gopinath Gnanasegaran, Francesco Giammarile, Marianne Pavel, Valentina Ambrosini, Richard P. Baum, Dieter Hörsch, James R. Howe, Marta Cremonesi, Ghassan El-Haddad, Yuni K. Dewaraja, Thomas A. Hope, David Taieb,Joint EANM, IAEA, and SNMMI practical guidance on somatostatin receptor-targeted radionuclide therapy of neuroendocrine tumours, The EANM Journal, 2026, 100017, ISSN 3051-2921, https://doi.org/10.1016/j.eanmj.2026.100017.Click here (https://www.sciencedirect.com/science/article/pii/S3051292126000047) Abstract: Somatostatin analogue-based Peptide Receptor Radionuclide Therapy (PRRT) is a molecularly targeted radiopharmaceutical therapy involving the systemic administration of a…