A prospective, randomized, Controlled, Open-label, Multicenter 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 tumors of gastroenteric or pancreatic origin (GEP-NETs).
COMPETE is an international, prospective (new data to be collected), randomized (patients randomly assigned by a computerized system to investigational or standard therapy group), controlled (investigational group compared to control group), open-label (patients and trial doctors know which drug is administered), multicenter phase III trial to evaluate the efficacy and safety of targeted radiopharmaceutical therapy (RPT) with n.c.a. Lutetium 177 edotreotide compared to everolimus in patients with Grade 1 or Grade 2 somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs).
Investigational medicinal treatment:
Targeted radiopharmaceutical therapy with n.c.a. Lutetium 177 edotreotide
N.c.a. Lutetium 177 edotreotide consists of the highly pure medical radioisotope, no-carrier-added (n.c.a.) Lutetium-177 used to destroy the tumor cells by emitting a small amount of radiation, and the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets neuroendocrine tumor-specific receptors and places the medical radioisotope directly onto the diseased neuroendocrine cells. Thanks to the highly precise localization, the healthy tissue surrounding the targeted tumor is minimally affected.
Active comparator treatment:
Everolimus, an immunosuppressive cancer therapy, established as one of the current standard of care treatments for GEP-NETs.
Study objectives:
Evaluate the efficacy and safety of RPT with n.c.a. Lutetium 177 edotreotide compared to everolimus in patients with Grade 1 or Grade 2 GEP-NETs.
*based on travel distance & country and according to sponsorship regulations
The trial has been evaluated favorably by the responsible ethics committee and has been approved by the responsible authority.
