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

NCT04919226 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: DP-1111-02CT
• Study Type: interventional
• Target: 259
• Locations: 10 countries
• Sites: 42

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.

Conditions

Neuroendocrine Tumors

Keywords

GastroEnteroPancreatic; non-functional and functional GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NET)

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• Overall Survival

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

Study Arms (2)

Peptide Receptor Radionuclide Therapy (PRRT) Arm

EXPERIMENTAL

Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT; Other: Amino-Acid Solution

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

ACTIVE COMPARATOR

Drug: CAPTEM (Capecitabine and Temozolomide); Drug: Everolimus; Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Interventions

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT DRUG

Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.

Also known as: 177Lu-DOTATOC 177Lu-Edo

Peptide Receptor Radionuclide Therapy (PRRT) Arm

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.

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

Amino-Acid Solution OTHER

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

Also known as: Arginine-Lysine Solution

Peptide Receptor Radionuclide Therapy (PRRT) Arm

Everolimus 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.

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

FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ITM Solucin GmbH: lead

Study Sites (42)

Stanford Cancer Center

Palo Alto, California, 94305, United States

Location

University of Colorado Hospital, Nuclear Medicine

Aurora, Colorado, 80045, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic - Rochester, Department of Oncology

Rochester, Minnesota, 55905, United States

Location

Washington University Alvin J. Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute

New York, New York, 10128, United States

Location

Duke University School of Medicine, Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Texas Oncology

Dallas, Texas, 75246, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, VIC 3000, Australia

Location

Fudan University Shanghai Cancer Center

Shanghai, 200000, China

Location

Affiliated Hospital of Jiangnan University

Wuxi, 214122, China

Location

Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology

Pessac, Bordeaux, 33604, France

Location

Nantes University Hospital Center - Hotel Dieu Hospital

Nantes, Cedex, 44093, France

Location

Edouard Herriot Hospital, Medical Oncology Unit

Lyon, 69003, France

Location

IUCT Oncopole - Institut Universitaire du Cancer de Toulouse

Toulouse, 31059, France

Location

Charite - University Hospital Berlin

Berlin, 13353, Germany

Location

University Hospital Bonn, Department of Nuclear Medicine

Bonn, 53127, Germany

Location

University Hospital Erlangen, Department of Internal Medicine I - Endocrinology

Erlangen, 91054, Germany

Location

University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine

Essen, 45147, Germany

Location

HCG Cancer Centre, Medical Oncology

Bangalore, Karnataka, 560027, India

Location

All India Institute Of Medical Sciences, Nuclear Medicine

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging

Mumbai, 400012, India

Location

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

Messina, 98125, Italy

Location

European Institute of Oncology (IEO), IRCCS

Milan, 20141, Italy

Location

University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology

Rome, 00168, Italy

Location

VU Medical Center (VUMC), Department of Medical Oncology

Amsterdam, 1081-HV, Netherlands

Location

Erasmus University Medical Center Rotterdam

Rotterdam, 3015 GD, Netherlands

Location

University Hospital Vall d'Hebron, Department of Medical Oncology

Barcelona, 08035, Spain

Location

ICO Hospitalet, Catalan Institute of Oncology

Barcelona, 199-203, Spain

Location

University General Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

University Hospital 12 de Octubre, Department of Gastroenterology

Madrid, 28041, Spain

Location

Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology

Oviedo, 33011, Spain

Location

University Hospital Complex of Santiago (CHUS)

Santiago de Compostela, 15706, Spain

Location

University and Polytechnic Hospital La Fe, Endocrinology

Valencia, 46026, Spain

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Gastro-enteropancreatic neuroendocrine tumor

Interventions

177Lu-octreotide, DOTA(0)-Tyr(3)-; Capecitabine; Temozolomide; amino-acid, glucose, and electrolyte solution; Everolimus; Folfox protocol; Leucovorin; Fluorouracil; Oxaliplatin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Sirolimus; Macrolides; Lactones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 9, 2021
• Study Start: December 21, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (2); NL (2); US (14); FR (4); IN (3); GB (1); IT (3); ES (7); AU (2); DE (4)