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

Neuroendocrine Tumors Clinical Trial

— COMPOSE  

Official title:

A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919226
• Other study ID #: DP-1111-02CT
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2021
• Est. completion date: September 2027

Study information

• Verified date: June 2024
• Source: ITM Solucin GmbH
• Contact: Nicolas Schneider, Dr
• Email: info-solucin[@]itm-radiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: September 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
• CAPTEM (Capecitabine and Temozolomide)
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.

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

Drug:
• Everolimus
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.
• FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
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.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
France	Edouard Herriot Hospital, Medical Oncology Unit	Lyon
France	Nantes University Hospital Center - Hotel Dieu Hospital	Nantes	Cedex
France	Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology	Pessac	Bordeaux
France	IUCT Oncopole - Institut Universitaire du Cancer de Toulouse	Toulouse
Germany	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
India	HCG Cancer Centre, Medical Oncology	Bangalore	Karnataka
India	Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging	Mumbai
India	All India Institute Of Medical Sciences, Nuclear Medicine	New Delhi	Delhi
Italy	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	University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology	Rome
Netherlands	VU Medical Center (VUMC), Department of Medical Oncology	Amsterdam
Netherlands	Erasmus University Medical Center Rotterdam	Rotterdam
Spain	ICO Hospitalet, Catalan Institute of Oncology	Barcelona
Spain	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
Sweden	Uppsala University Hospital, Department of Oncology	Uppsala
United Kingdom	King's College Hospital	London
United Kingdom	Royal Free Hospital	London
United States	University of Colorado Hospital, Nuclear Medicine	Aurora	Colorado
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Texas Oncology	Dallas	Texas
United States	Duke University School of Medicine, Duke Cancer Institute	Durham	North Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Stanford Cancer Center	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic - Rochester, Department of Oncology	Rochester	Minnesota
United States	Washington University Alvin J. Siteman Cancer Center	Saint Louis	Missouri
United States	University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ITM Solucin GmbH

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  India,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Overall Survival	OS (Overall Survival), defined as the time from randomization until death;	Up to 2 years after disease progression