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

Phase 3

Active, not recruiting

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

• Registration Number: NCT04919226
• Lead Sponsor: ITM Solucin GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-09
• Study Start: 2021-12-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-05-29
• Primary Completion: 2027-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 259

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peptide Receptor Radionuclide Therapy (PRRT) Arm	177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT	-
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)	FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)	-
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)	CAPTEM (Capecitabine and Temozolomide)	-
Peptide Receptor Radionuclide Therapy (PRRT) Arm	Amino-Acid Solution	-
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)	Everolimus	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	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.	PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 2 years after disease progression	OS (Overall Survival), defined as the time from randomization until death;

Trial Locations

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

Washington University Alvin J. Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute; 🇺🇸 New York, New York, United States

Duke University School of Medicine, Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

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