Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

Phase 3Active Not RecruitingNCT04919226

ITM Solucin GmbH259 enrolled

Overview

The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

259

Conditions

Neuroendocrine Tumors

Interventions

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT

CAPTEM (Capecitabine and Temozolomide)DRUG

Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

EverolimusDRUG

FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged ≥ 18 years. * Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI). * Somatostatin receptor-positive (SSTR+) disease. Exclusion Criteria: * Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin). * Prior (Peptide Receptor Radionuclide Therapy) PRRT. * Any major surgery within 4 weeks prior to randomization in the trial. * Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization. * Other known malignancies. * Serious non-malignant disease. * Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments. * Pregnant or breastfeeding women. * Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.

Locations (42)

Stanford Cancer Center

Palo Alto, California, United States

University of Colorado Hospital, Nuclear Medicine

Aurora, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic - Rochester, Department of Oncology

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Progression-Free Survival

PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression or death, whichever occurs first.

Time frame: Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events.

Secondary Outcomes

Overall Survival

OS (Overall Survival), defined as the time from randomization until death;

Time frame: Up to 3 years after disease progression, or to a maximum of 5 years after randomization