This website uses cookies to improve user experience. By using our website you consent to all cookies in accordance with our Cookie Policy.
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 (COMPOSE).
COMPOSE is an international, prospective (new data to be collected), randomized (patients randomly assigned by a computerized system to investigational or standard of care 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, safety and impact on quality of life of targeted radiopharmaceutical therapy (RPT) with n.c.a. Lutetium 177 edotreotide compared to current best standard of care in patients with well-differentiated advanced Grade 2 and Grade 3 somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (G2 and G3 GEP-NETs).
Investigational medicinal treatment:
Targeted Radiopharmaceutical Therapy with no-carrier-added (n.c.a.) Lutetium 177 edotreotide
N.c.a. Lutetium 177 edotreotide consists of the highly pure medical radioisotope, 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. The highly precise localization can result in the healthy tissue surrounding the targeted tumor being minimally affected.
Active comparator treatment:
Standard therapy with either capecitabine and temozolomide (CAPTEM), or everolimus, or folinic acid, fluorouracil and oxaliplatin (FOLFOX).
Study objectives:
Evaluate the efficacy, safety and impact on quality of life of the targeted radiopharmaceutical n.c.a. Lutetium 177 edotreotide compared to a standard therapy with either CAPTEM or everolimus or FOLFOX in patients with advanced Grade 2 or Grade 3 GEP-NETs.
Optional genomic profiling sub-study:
In an optional sub-study, only if the patients consent to, genomic changes will be analyzed in the blood at 4 different time points and in the tumoral tissue. This sub-study aims to identify the genomic elements that can contribute in predicting how well the treatment works and how the disease will develop. Both treatment and trial procedures will not be modified based on the results of this genomic testing.
* based on travel distance & country and according to local and sponsorship regulations
The trial has been evaluated favorably by the responsible ethics committee and has been approved by the responsible authority.