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Study Design COMPOSEFAQs COMPOSEParticipating Sites COMPOSE

Study Design COMPOSE

Official Title

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).

Key Facts

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 physicians know which drug is administered), multicenter phase III study to evaluate the efficacy, safety and impact on quality of life of Targeted Radionuclide Therapy with n.c.a. Lutetium-177-Edotreotide compared to 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 Radionuclide 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. 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). The standard therapy assigned to you will be determined by the doctor based on your individual benefit-risk assessment and will follow institutional protocols, local prescribing information, local reguations 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.

Key Participation Features

  • only standard of care treatments in the control arm, no placebo (medication without active ingredient for cancer treatment)
  • participation of patients with and without prior GEP-NET medical treatment possible (study treatment options offered as fist-line and second-line therapy)
  • special kidney protection will be provided during Targeted Radionuclide Therapy
  • study treatment costs will be covered
  • should travel be necessary expenses will be covered*
     

* based on travel distance & country and according to local and sponsorship regulations

The study has been evaluated favorably by the responsible ethics committee and has been approved by the responsible authority.

Please also see COMPOSE study information on clinicaltrials.gov, Identifier: NCT04919226