Clinical trial • Phase III • Oncology

Lutetium (177Lu) edotreotide for Gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Phase III trial of Lutetium (177Lu) edotreotide for Gastroenteropancreatic neuroendocrine tumour (GEP-NET).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
Trial Stage
Phase III
Drug Modality
Radiopharmaceutical|Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
15-07-2024

Trial design

Randomised, open-label, 177lu-edotreotide: 7.5 ± 0.7 gbq administered iv infusion for 6 cycles (cycle 1 followed by cycle 2 given 6 (+2) weeks later, then cycles 3-6 given 8 (±1) weeks after the previous cycle. best standard of care (investigator's choice): investigator selects from captem (capecitabine + temozolomide), everolimus, or folfox according to individual risk–benefit, institutional protocols and local guidelines; specific doses/schedules for comparators per local prescribing information and protocol comparator list (not specified in ctis summary).-controlled Phase III trial in Netherlands, Italy, France and others.

Randomised
Yes
Open Label
Yes
Comparator
177Lu-Edotreotide: 7.5 ± 0.7 GBq administered IV infusion for 6 cycles (Cycle 1 followed by Cycle 2 given 6 (+2) weeks later, then Cycles 3-6 given 8 (±1) weeks after the previous cycle. Best standard of care (investigator's choice): investigator selects from CAPTEM (capecitabine + temozolomide), everolimus, or FOLFOX according to individual risk–benefit, institutional protocols and local guidelines; specific doses/schedules for comparators per local prescribing information and protocol comparator list (not specified in CTIS summary).
Target Sample Size
97

Eligibility

Recruits 97 Exclusion criterion: "Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that." Participants unable to provide meaningful informed consent are excluded. Consent must be obtained from the participant (no paediatric/assent procedures described)..

Pregnancy Exclusion
8. Pregnant or breastfeeding women.
Vulnerable Population
Exclusion criterion: "Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that." Participants unable to provide meaningful informed consent are excluded. Consent must be obtained from the participant (no paediatric/assent procedures described).

Inclusion criteria

  • {"criterion_text":"- 1. Patients aged ≥18 years.\n- 2. 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).\n- 3. Somatostatin receptor-positive (SSTR+) disease."}

Exclusion criteria

  • {"criterion_text":"- 1. Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).\n- 2. Prior (Peptide Receptor Radionuclide Therapy) PRRT.\n- 3. Any major surgery within 4 weeks prior to randomization in the trial.\n- 4. Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.\n- 5. Other known malignancies.\n- 6. Serious non-malignant disease.\n- 7. Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.\n- 8. Pregnant or breastfeeding women.\n- 9. Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":"Time from randomization until disease progression per RECIST v1.1 or death; main analyses based on blinded, central RECIST v1.1 assessment."}

Secondary endpoints

  • {"endpoint_text":"- 1. Further demonstration of efficacy:\n- 1.1 Overall survival (OS), defined as the time from randomization until death.\n- 1.2 PFS (local), defined as the time from randomization until adequately documented RECIST v1.1 disease progression (based on local assessment) or death, whichever occurs first.\n- For all endpoints based on RECIST v1.1, main analyses will be based on blinded, central assessment. Local assessments will be presented as sensitivity analyses.\n- 1.3 Disease control rate (DCR), defined as the proportion of randomized patients with complete response (CR), partial response (PR), or stable disease (SD) (RECIST v1.1).\n- 1.4 Duration of disease control (DDC), defined as the time from experiencing CR, PR or SD until the next subsequent progressive disease (PD) (RECIST v1.1).\n- 1.5 Objective response rate (ORR), defined as the proportion of randomized patients with CR or PR (RECIST v1.1).\n- 1.6 Duration of response (DoR), defined as the time from experiencing first CR or PR until PD (RECIST v1.1).\n- 2. Two HRQL (European Organization for Research and Treatment of Cancer [EORTC]) quality of life questionnaires ([QLQ]-C30 and –GI.NET21):\n- 2.1 Maximum HRQL improvement in total scores relative to baseline.\n- 2.2 Duration of maximum HRQL improvement, defined as the time from maximum improvement until subsequent deterioration.\n- 2.3 Time to HRQL deterioration, defined as the time from randomization until first HRQL deterioration.\n- 3. Safety and tolerability based on adverse events, laboratory data and vital signs.","definition_or_measurement_approach":"Endpoints based on RECIST v1.1 will use blinded central RECIST assessment for primary analyses; OS defined as time from randomization to death; PFS (local) defined as time from randomization to documented RECIST v1.1 progression or death; DCR/ORR/DoR/DDC defined per RECIST v1.1; HRQL measured using EORTC QLQ-C30 and GI.NET21; safety assessed by adverse events, labs and vital signs."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
97
Recruitment Window Months
102
Consent Approach
Informed consent must be obtained from the participant (study enrolment requires patient to be ≥18 years). Participants unable to provide meaningful informed consent are excluded. Multiple Subject Information Sheets and Informed Consent Forms (L1_SIS and ICF) are provided, including language/local versions (translations/synopses in Spanish, Dutch, French, Italian are present; an Arabic ICF version is also listed). Optional genomic profiling consent and pregnant-partner information documents are available. No paediatric assent procedures are described.

Methods

  • Letter to Investigators (K2_Recruitment Materials / Dear Dr Letter) — channel: mailed/email letters to investigators; target audience: investigators/clinicians.
  • Patient Brochure (K2_Recruitment Materials) — channel: print/PDF brochure; target audience: potential patient participants.
  • Patient Flyer (K2_Recruitment Materials) — channel: print/PDF flyer; target audience: potential patient participants.
  • Website Content (K2_Recruitment Material_Website Content) — channel: sponsor/trial website; target audience: general public/patients.
  • GP Letter / Doctor Letter — channel: letters to primary care physicians; target audience: general practitioners/referring physicians.
  • Patient Reimbursement Form — channel: site-provided material; target audience: enrolled patients (reimbursement information).
  • Patient materials and recruitment arrangements available with country-specific versions (documents present for multiple Member States: FR, ES, IT, NL, ES).

Geography

Total Number Of Sites
20
Total Number Of Participants
153

Netherlands

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
17-06-2025
Processing Time Days
340
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Internal Medicine
Contact Person Name
Johannes Hofland
Contact Person Email
j.hofland@erasmusmc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Medical Oncology
Contact Person Name
Willemien Menke-van der Houven van Oordt
Contact Person Email
c.menke@amsterdamumc.nl

Italy

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
19-06-2025
Processing Time Days
342
Number Of Sites
3
Number Of Participants
31

Sites

Site Name
European Institute Of Oncology S.r.l.
Department Name
Gastrointestinal Medical Oncology and Neuroendocrine Tumors Unit
Contact Person Name
Nicola Fazio
Contact Person Email
nicola.fazio@ieo.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Complex Operational Unit of Nuclear Medicine
Contact Person Name
Massimiliano Siracusa
Contact Person Email
na.na@na.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Medical Oncology
Contact Person Name
Giovanni Schinzari

France

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
20-06-2025
Processing Time Days
343
Number Of Sites
4
Number Of Participants
44

Sites

Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Nuclear Medicine and Metabolic Irradiation/ Digestive Oncology
Contact Person Name
Lawrence Dierickx
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Nuclear Medicine/ Digestive Oncology
Contact Person Name
Catherine Ansquer
Site Name
Hospital Edouard Herriot
Department Name
Hepato-Gastroenterology and Digestive Oncology/ Nuclear Medicine
Contact Person Name
Thomas Walter
Contact Person Email
thomas.walter@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Digestive Oncology/ Nuclear Medicine
Contact Person Name
Denis Smith
Contact Person Email
denis.smith@chu-bordeaux.fr

Germany

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
18-06-2025
Processing Time Days
341
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Universitaetsklinikum Bonn AöR
Department Name
Department of Nuclear Medicine
Contact Person Name
Markus Essler
Contact Person Email
Markus.Essler@ukbonn.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Hepatology and Gastroenterology
Contact Person Name
Peter Steinhagen
Contact Person Email
peter.steinhagen@charite.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Nuclear Medicine
Contact Person Name
Ken Herrmann
Contact Person Email
ken.herrmann@uk-essen.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Division of Endocrinology
Contact Person Name
Marianne Pavel
Contact Person Email
Marianne.Pavel@uk-erlangen.de

Spain

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
488
Number Of Sites
7
Number Of Participants
63

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Contact Person Name
Aitana Calvo Ferrandiz
Site Name
Hospital Universitario 12 De Octubre
Department Name
Department of Gastroenterology
Contact Person Name
Rocio Garcia-Carbonero
Contact Person Email
rgcarbonero.ensayos@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medical Oncology
Contact Person Name
Angel Agustin Segura Huerta
Contact Person Email
segura_ang@gva.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Nuclear Medicine
Contact Person Name
Virginia Pubul Núñez
Contact Person Email
virginia.pubul.nunez@sergas.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Medical Oncology
Contact Person Name
Paula Jimenez-Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Jaume Capdevila
Contact Person Email
jcapdevila@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Alexandre Teule Vega
Contact Person Email
ateule@iconcologia.net

Sponsor

Primary sponsor

Full Name
ITM Solucin GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Psi Cro AG
Responsibilities
codes: 1,11,12,2,3,5,6,7,8
Name
Everest Clinical Research Corporation
Responsibilities
code: 10
Name
Suvoda LLC
Responsibilities
code: 3
Name
Medidata Solutions International Limited
Responsibilities
code: 7
Name
Keosys
Responsibilities
Medical image analysis

Third parties

  • {"country":"France","full_name":"Keosys","duties_or_roles":"Medical image analysis","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"codes: 1,11,12,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Adamas Consulting Limited","duties_or_roles":"code: 9","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"CeGaT GmbH","duties_or_roles":"genomic profiling","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"lab kits production and shipment","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"Asphalion S.L.","duties_or_roles":"other PV-related activities; code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"Study Data Tabulation Model (SDTM), statistical analysis","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Everest Clinical Research Corporation","duties_or_roles":"code: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Erlangen AöR","duties_or_roles":"manufacturing of nephroprotective amino acid","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eTMF","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"patient concierge","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
177Lu-Edotreotide
Active Substance
Lutetium (177Lu) edotreotide
Modality
Radiopharmaceutical
Routes Of Administration
Intravenous use (IV infusion)
Route
Intravenous infusion
Authorisation Status
Authorised (prodAuthStatus=1)
Orphan Designation
Yes
Starting Dose
7.5 ± 0.7 GBq
Dose Levels
7.5 ± 0.7 GBq per cycle for up to 6 cycles (total up to 45 GBq)
Frequency
Cycle 1; Cycle 2 at 6 (+2) weeks after Cycle 1; Cycles 3-6 given 8 (±1) weeks after previous cycle
Maximum Dose
Maximum total 45 GBq

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