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: 2025-09
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-10
• Primary Completion: 2027-06
• Study Completion: 2027-09-01

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 or death, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 3 years after disease progression, or to a maximum of 5 years after randomization	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; 🇺🇸 St 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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