Clinical trial NCT04919226: Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Keywords: GastroEnteroPancreatic
non-functional and functional GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NET)
Lead sponsor: ITM Solucin GmbH
Sponsor class: INDUSTRY
First posted: 2021-06-09
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 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:
measure: Overall Survival
timeFrame: Up to 2 years after disease progression
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital, Nuclear Medicine
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester, Department of Oncology
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Alvin J. Siteman Cancer Center
state: Missouri
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute
state: New York
city: Durham
country: United States
facility: Duke University School of Medicine, Duke Cancer Institute
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
city: Pessac
country: France
facility: Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology
state: Bordeaux
city: Nantes
country: France
facility: Nantes University Hospital Center - Hotel Dieu Hospital
state: Cedex
city: Lyon
country: France
facility: Edouard Herriot Hospital, Medical Oncology Unit
city: Toulouse
country: France
facility: IUCT Oncopole - Institut Universitaire du Cancer de Toulouse
city: Berlin
country: Germany
facility: Charite - University Hospital Berlin
city: Bonn
country: Germany
facility: University Hospital Bonn, Department of Nuclear Medicine
city: Erlangen
country: Germany
facility: University Hospital Erlangen, Department of Internal Medicine I - Endocrinology
city: Essen
country: Germany
facility: University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine
city: New Delhi
country: India
facility: All India Institute Of Medical Sciences, Nuclear Medicine
state: Delhi
city: Bangalore
country: India
facility: HCG Cancer Centre, Medical Oncology
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging
city: Messina
country: Italy
facility: University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine
city: Milan
country: Italy
facility: European Institute of Oncology (IEO), IRCCS
city: Rome
country: Italy
facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology
city: Amsterdam
country: Netherlands
facility: VU Medical Center (VUMC), Department of Medical Oncology
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center Rotterdam
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron, Department of Medical Oncology
city: Barcelona
country: Spain
facility: ICO Hospitalet, Catalan Institute of Oncology
city: Madrid
country: Spain
facility: University General Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre, Department of Gastroenterology
city: Oviedo
country: Spain
facility: Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology
city: Santiago De Compostela
country: Spain
facility: University Hospital Complex of Santiago (CHUS)
city: Valencia
country: Spain
facility: University and Polytechnic Hospital La Fe, Endocrinology
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
References: