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. Thanks to the highly precise localization, the healthy tissue surrounding the targeted tumor is minimally affected.
Active comparator treatment:
Standard therapy with either capecitabine and temozolomide (CAPTEM), or everolimus, or folinic acid, fluorouracil and oxaliplatin (FOLFOX). The standard therapy assigned to you will be determined by the trial doctor based on your individual benefit-risk assessment and will follow institutional protocols, local prescribing information, local regulations or local guidelines.
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 it, 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 to predicting how well the treatment works and how the disease will evolve. Neither treatment nor trial procedures will 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.
