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

ITM Isotope Technologies Munich

Status and phase: Enrolling; Phase 3

Conditions: Neuroendocrine Tumors

Treatments: Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin); Other: Amino-Acid Solution; Drug: CAPTEM (Capecitabine and Temozolomide); Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT; Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04919226

DP-1111-02CT

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Peptide Receptor Radionuclide Therapy (PRRT) Arm

Experimental group

Treatment:

Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT

Other: Amino-Acid Solution

CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)

Active Comparator group

Treatment:

Drug: Everolimus

Drug: CAPTEM (Capecitabine and Temozolomide)

Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)