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

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: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 (45)

ICO Hospitalet, Catalan Institute of Oncology; 🇪🇸 Barcelona, Spain

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

Affiliated Hospital of Jiangnan University; 🇨🇳 Wuxi, China

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

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Oncology; 🇺🇸 Dallas, Texas, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Utah, Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology; 🇫🇷 Pessac, Bordeaux, France

Nantes University Hospital Center - Hotel Dieu Hospital; 🇫🇷 Nantes, Cedex, France

Edouard Herriot Hospital, Medical Oncology Unit; 🇫🇷 Lyon, France

IUCT Oncopole - Institut Universitaire du Cancer de Toulouse; 🇫🇷 Toulouse, France

Charite - University Hospital Berlin; 🇩🇪 Berlin, Germany

University Hospital Bonn, Department of Nuclear Medicine; 🇩🇪 Bonn, Germany

University Hospital Erlangen, Department of Internal Medicine I - Endocrinology; 🇩🇪 Erlangen, Germany

University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine; 🇩🇪 Essen, Germany

Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging; 🇮🇳 Mumbai, India

University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine; 🇮🇹 Messina, Italy

European Institute of Oncology (IEO), IRCCS; 🇮🇹 Milan, Italy

University Hospital "Federico II", Department of Molecular and Clinical Endocrinology and Oncology; 🇮🇹 Naples, Italy

VU Medical Center (VUMC), Department of Medical Oncology; 🇳🇱 Amsterdam, Netherlands

Erasmus University Medical Center Rotterdam; 🇳🇱 Rotterdam, Netherlands

All India Institute Of Medical Sciences, Nuclear Medicine; 🇮🇳 New Delhi, Delhi, India

HCG Cancer Centre, Medical Oncology; 🇮🇳 Bangalore, Karnataka, India

University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology; 🇮🇹 Rome, Italy

University Hospital Vall d'Hebron, Department of Medical Oncology; 🇪🇸 Barcelona, Spain

University General Hospital Gregorio Maranon; 🇪🇸 Madrid, Spain

University Hospital 12 de Octubre, Department of Gastroenterology; 🇪🇸 Madrid, Spain

Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology; 🇪🇸 Oviedo, Spain

University Hospital Complex of Santiago (CHUS); 🇪🇸 Santiago De Compostela, Spain

University and Polytechnic Hospital La Fe, Endocrinology; 🇪🇸 Valencia, Spain

Uppsala University Hospital, Department of Oncology; 🇸🇪 Uppsala, Sweden

Royal Free Hospital; 🇬🇧 London, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom