Clinical trial • Phase II • Oncology

LUTETIUM (177LU) OXODOTREOTIDE for Recurrent meningioma

Phase II trial of LUTETIUM (177LU) OXODOTREOTIDE for Recurrent meningioma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Recurrent meningioma
Trial Stage
Phase II
Drug Modality
Radiopharmaceutical | Small molecule | Monoclonal antibody | Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
20-08-2024
First CTIS Authorization Date
11-12-2024

Trial design

Randomised, comparator arms: sunitinib (max daily dose reported: 50 mg, oral; schedule not specified), hydroxycarbamide / hydroxyurea (reported dosing unit: up to 30 mg/kg, oral; schedule not specified), bevacizumab (reported dose: 15 mg/kg, intravenous infusion; schedule not specified), octreotide acetate (reported dose: 30 mg, intramuscular injection; schedule not specified), everolimus (reported dose: 10 mg, oral; schedule not specified).-controlled Phase II trial in Austria, Norway, Germany and others.

Randomised
Yes
Comparator
Comparator arms: Sunitinib (max daily dose reported: 50 mg, oral; schedule not specified), Hydroxycarbamide / Hydroxyurea (reported dosing unit: up to 30 mg/kg, oral; schedule not specified), Bevacizumab (reported dose: 15 mg/kg, intravenous infusion; schedule not specified), Octreotide acetate (reported dose: 30 mg, intramuscular injection; schedule not specified), Everolimus (reported dose: 10 mg, oral; schedule not specified).
Biomarker Stratified
True (Somatostatin receptor (SSTR) positivity by PET required for enrollment; baseline SSTR-PET considered positive when meningioma uptake intensity exceeds a SUVmax of 2.3).

Eligibility

Recruits 106 Vulnerable population selected. Participants are adults (≥18 years). "Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations." No additional details on assent or special consent procedures for vulnerable adults are provided in the available documents..

Pregnancy Exclusion
Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to enrolment. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test will have to be reported within 7 days prior to the first dose of the study treatment.
Vulnerable Population
Vulnerable population selected. Participants are adults (≥18 years). "Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations." No additional details on assent or special consent procedures for vulnerable adults are provided in the available documents.

Inclusion criteria

  • {"criterion_text":"- Adult patient ≥ 18 years of age\n- Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 7 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n- Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 7 months after the last study treatment.\n- Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.\n- Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible)\n- WHO performance status 0-2\n- Measurable disease (at least 10 x 10 mm contrast enhancing lesion) on cranial MRI no more than two weeks prior to enrolment\n- Radiologically documented progression of any existing tumour (growth > 25% in the last two years) or appearance of new lesions (including intra- and extracranial manifestations)\n- Somatostatin receptor (SSTR)-positive confirmed by PET imaging with scan performed within four weeks before randomization (baseline SSTR-PET is considered as positive when meningioma uptake intensity exceeds a SUVmax of 2.3).\n- At least one prior surgery and one line of external beam radiotherapy for meningioma, if technically feasible\n- Adequate liver, renal and haematological function within four weeks prior to enrolment\n- Participants must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication: • Potassium (potassium level of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance ≥ 60 mL/min calculated using CKD-EPI formula). Mild decrease below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by investigator. • Total magnesium, with the exception of magnesium level > ULN – 3.0 mg/dL (1.23 mmol/L) associated with creatinine clearance ≥ 60 mL/min calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator. • Total calcium (corrected for serum albumin) level of up to 12.5 mg/dL (3.1 mmol/L) is acceptable at study entry if associated with creatinine clearance ≥ 60 mL/min calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator. • Patients who are receiving corticosteroid treatment with dexamethasone, must be treated with a dose of ≤4 mg/day (or other corticosteroids equivalent dose) for a minimum of 7 days prior to the initiation of study treatment. • Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to enrolment. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test will have to be reported within 7 days prior to the first dose of the study treatment."}

Exclusion criteria

  • {"criterion_text":"- Local therapy (surgery and / or radiotherapy) indicated per local investigator. Note: in case of patients with multiple meningioma lesions, in whom resection and / or radiotherapy of individual lesions is indicated, patients may be included after local therapy (with a 4-week gap between surgery / end of radiotherapy and start of treatment), if at least one remaining lesion fulfils the inclusion criteria.\n- Any prior systemic treatment regardless of the timing.\n- Life expectancy is less than nine weeks.\n- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study treatment.\n- Contraindication to MRI, CT or PET\n- Unstable cardiac conditions (congestive heart failure, angina pectoris, myocardial infarction within one year before enrolment, uncontrolled hypertension, clinically significant arrhythmias)\n- Psychological, familial, sociological, or geographical conditions could potentially hamper compliance with the study protocol and follow-up schedule.\n- Known hypersensitivity to the active substance or to any excipients."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint in this phase II study is progression-free survival (PFS) computed based on MRI-based RANO meningioma response criteria as assessed by the local investigator.","definition_or_measurement_approach":"Progression-free survival (PFS) computed based on MRI-based RANO meningioma response criteria as assessed by the local investigator."}

Secondary endpoints

  • {"endpoint_text":"- Best overall response (BOR, defined as complete response (CR), minor response (MR) or partial response (PR) during study treatment). Objective response (CR/MR/PR) rate and median CR/MR/PR duration. Complete response rate and median CR duration computed by MRI based on RANO meningioma response criteria as assessed by the local investigator.","definition_or_measurement_approach":"BOR defined as CR, MR, or PR during study treatment; computed by MRI using RANO meningioma response criteria as assessed by local investigator. Outcomes include objective response rate and median duration."}
  • {"endpoint_text":"- Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS).","definition_or_measurement_approach":"Overall survival measured as time from randomization to death; reported probabilities at 6 and 12 months and median OS."}
  • {"endpoint_text":"- Safety (CTCAE v.5.0) and tolerability ([177Lu]Lu-DOTATATE only).","definition_or_measurement_approach":"Safety assessed using CTCAE v5.0; tolerability assessments for [177Lu]Lu-DOTATATE."}
  • {"endpoint_text":"- Change from baseline in HRQoL in terms of the global QoL, cognitive functioning, social functioning and fatigue at week 24.","definition_or_measurement_approach":"Change from baseline in health-related quality of life domains (global QoL, cognitive, social, fatigue) at Week 24, measured by patient-reported questionnaires (QLQ instruments referenced in patient-facing documents)."}
  • {"endpoint_text":"- Change of neurological function (NANO scale) from baseline during study treatment.","definition_or_measurement_approach":"Change in neurological function measured by the NANO scale compared to baseline during study treatment."}

Recruitment

Recruitment Window Months
53
Consent Approach
Written informed consent is required prior to enrolment in accordance with ICH/GCP and national/local regulations; participants are adults (≥18) and provide their own consent. Subject information and informed consent forms (L1_SIS and ICF) and patient-facing documents are available in country-specific versions and multiple languages (examples in the dossier include AT/DE, FR, ES, NO, NL and English lay synopsis). No procedures for assent (paediatric) or additional surrogate consent mechanisms are provided in the available documents.

Geography

Total Number Of Sites
29
Total Number Of Participants
106

Austria

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
15-12-2024
Processing Time Days
6
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Neurochirurgie
Principal Investigator Name
Christian Freyschlag
Principal Investigator Email
christian.freyschlag@tirol-kliniken.at
Contact Person Name
Christian Freyschlag
Site Name
Medical University Of Vienna
Department Name
Department of Medicine I, Division of Oncology
Principal Investigator Name
Matthias Preusser
Principal Investigator Email
matthias.preusser@meduniwien.ac.at
Contact Person Name
Matthias Preusser

Norway

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
15
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
St. Olavs Hospital HF
Department Name
Cancer clinic
Principal Investigator Name
Tora Skeidsvoll Solheim
Principal Investigator Email
tora.s.solheim@ntnu.no
Contact Person Name
Tora Skeidsvoll Solheim
Contact Person Email
tora.s.solheim@ntnu.no
Site Name
Oslo University Hospital HF
Department Name
Oncology
Principal Investigator Name
Petter Brandal
Principal Investigator Email
petter.brandal@ous-hf.no
Contact Person Name
Petter Brandal
Contact Person Email
petter.brandal@ous-hf.no

Germany

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
15
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Goethe University Frankfurt
Department Name
TBC
Principal Investigator Name
Michael Burger
Principal Investigator Email
burger@med.uni-frankfurt.de
Contact Person Name
Michael Burger
Contact Person Email
burger@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
TBC
Principal Investigator Name
Antje Wick
Principal Investigator Email
antje.wick@med.uni-heidelberg.de
Contact Person Name
Antje Wick
Site Name
Universitaetsklinikum Essen AöR
Department Name
TBC
Principal Investigator Name
Martin Glas
Principal Investigator Email
martin.glas@uk-essen.de
Contact Person Name
Martin Glas
Contact Person Email
martin.glas@uk-essen.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
TBC
Principal Investigator Name
Louisa von Baumgarten
Principal Investigator Email
Louisa.vonBaumgarten@med.uni-muenchen.de
Contact Person Name
Louisa von Baumgarten

Spain

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
12-12-2024
Processing Time Days
29
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical oncology
Principal Investigator Name
Juan Manuel Sepulveda
Principal Investigator Email
sepulvedasanchez@seom.org
Contact Person Name
Juan Manuel Sepulveda
Contact Person Email
sepulvedasanchez@seom.org
Site Name
Hospital Clinico San Carlos
Department Name
Medical oncology
Principal Investigator Name
Santiago Cabezas-Camarero
Principal Investigator Email
santiago.cabezas@salud.madrid.org
Contact Person Name
Santiago Cabezas-Camarero
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical oncology
Principal Investigator Name
Maria Vieito Villar
Principal Investigator Email
mvieito@vhio.net
Contact Person Name
Maria Vieito Villar
Contact Person Email
mvieito@vhio.net

France

Earliest CTIS Part Ii Submission Date
04-12-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
7
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Institut Gustave Roussy
Department Name
Medical oncology
Principal Investigator Name
David Guyon
Principal Investigator Email
David.GUYON@gustaveroussy.fr
Contact Person Name
David Guyon
Contact Person Email
David.GUYON@gustaveroussy.fr
Site Name
Hospices Civils De Lyon
Department Name
Neuro-oncology
Principal Investigator Name
Francois Ducray
Principal Investigator Email
francois.ducray@chu-lyon.fr
Contact Person Name
Francois Ducray
Contact Person Email
francois.ducray@chu-lyon.fr
Site Name
Centre Leon Berard
Department Name
Medical oncology
Principal Investigator Name
Aurelien Maureille
Principal Investigator Email
aurelien.maureille@lyon.unicancer.fr
Contact Person Name
Aurelien Maureille
Site Name
Oncopole Claudius Regaud
Department Name
Nuclear medicine
Principal Investigator Name
Lavinia Vija
Principal Investigator Email
Vija.Lavinia@iuct-oncopole.fr
Contact Person Name
Lavinia Vija
Contact Person Email
Vija.Lavinia@iuct-oncopole.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncology
Principal Investigator Name
Elodie Vauleon
Principal Investigator Email
E.Vauleon@rennes.unicancer.fr
Contact Person Name
Elodie Vauleon
Contact Person Email
E.Vauleon@rennes.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurology
Principal Investigator Name
Marc Sanson
Principal Investigator Email
marc.sanson@aphp.fr
Contact Person Name
Marc Sanson
Contact Person Email
marc.sanson@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncology
Principal Investigator Name
Emeline Tabouret
Principal Investigator Email
emeline.tabouret@gmail.com
Contact Person Name
Emeline Tabouret
Contact Person Email
emeline.tabouret@gmail.com
Site Name
CHRU De Nancy
Department Name
Nuclear medicine
Principal Investigator Name
Antoine Verger
Principal Investigator Email
a.verger@chru-nancy.fr
Contact Person Name
Antoine Verger
Contact Person Email
a.verger@chru-nancy.fr

Denmark

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
31
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Rigshospitalet
Department Name
Oncology
Principal Investigator Name
Søren Møller
Principal Investigator Email
soeren.moeller.01@regionh.dk
Contact Person Name
Søren Møller
Contact Person Email
soeren.moeller.01@regionh.dk
Site Name
Odense University Hospital
Department Name
Oncology
Principal Investigator Name
Rikke Hedegaard Dahlrot
Principal Investigator Email
rikke.dahlrot@rsyd.dk
Contact Person Name
Rikke Hedegaard Dahlrot
Contact Person Email
rikke.dahlrot@rsyd.dk

Italy

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
47
Number Of Sites
5
Number Of Participants
33

Sites

Site Name
Instituto Di Ricovero E Cura A Carattere Scientifico (Ospedale Bellaria)
Department Name
Nervous system medical oncology
Principal Investigator Name
Enrico Franceschi
Principal Investigator Email
e.franceschi@isnb.it
Contact Person Name
Enrico Franceschi
Contact Person Email
e.franceschi@isnb.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Neuro-oncology
Principal Investigator Name
Veronica Villani
Principal Investigator Email
veronica.villani@ifo.it
Contact Person Name
Veronica Villani
Contact Person Email
veronica.villani@ifo.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Principal Investigator Name
Giuseppe Lombardi
Principal Investigator Email
giuseppe.lombardi@iov.veneto.it
Contact Person Name
Giuseppe Lombardi
Site Name
Humanitas Mirasole S.p.A.
Department Name
Bioscience
Principal Investigator Name
Laura Evangelista
Principal Investigator Email
laura.evangelista@hunimed.eu
Contact Person Name
Laura Evangelista
Contact Person Email
laura.evangelista@hunimed.eu
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Neuro-oncology
Principal Investigator Name
Roberta Ruda
Principal Investigator Email
roberta.ruda@unito.it
Contact Person Name
Roberta Ruda
Contact Person Email
roberta.ruda@unito.it

Netherlands

Earliest CTIS Part Ii Submission Date
20-01-2026
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
16
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Neuro-surgery
Principal Investigator Name
Mark ter Laan
Principal Investigator Email
Mark.terLaan@radboudumc.nl
Contact Person Name
Mark ter Laan
Contact Person Email
Mark.terLaan@radboudumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Radiology and Nuclear Medicine
Principal Investigator Name
Sophie Veldhuijzen van Zanten
Principal Investigator Email
s.veldhuijzenvanzanten@erasmusmc.nl
Contact Person Name
Sophie Veldhuijzen van Zanten
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Radiology and nuclear medicine
Principal Investigator Name
Nelleke Tolboom
Principal Investigator Email
n.tolboom@umcutrecht.nl
Contact Person Name
Nelleke Tolboom
Contact Person Email
n.tolboom@umcutrecht.nl

Sponsor

Primary sponsor

Full Name
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
Organisation Type
Patient organisation/association
Country Of Registered Address
Belgium

Contract research organisations

Name
Klinikos Limited
Responsibilities
On-site monitoring in Norway and Denmark
Name
TrialPEX
Responsibilities
Reimbursement of patients travel costs in France

Third parties

  • {"country":"United Kingdom","full_name":"Klinikos Limited","duties_or_roles":"On-site monitoring in Norway and Denmark","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"TrialPEX","duties_or_roles":"Reimbursement of patients travel costs in France","organisation_type":"Industry"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"Central pathology review, processing and storage of tumour samples, translational research.","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Lutathera 370 MBq/mL solution for infusion
Active Substance
LUTETIUM (177LU) OXODOTREOTIDE
Modality
Radiopharmaceutical
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
EU/1/17/1226/001
Orphan Designation
Yes
Maximum Dose
7.4 GBq (max total 29.6 GBq)
Investigational Product Name
BEVACIZUMAB
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Maximum Dose
15 mg/kg
Investigational Product Name
SUNITINIB
Active Substance
SUNITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
50 mg
Investigational Product Name
HYDROXYCARBAMIDE
Active Substance
HYDROXYCARBAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
30 mg/kg
Investigational Product Name
OCTREOTIDE ACETATE
Active Substance
OCTREOTIDE ACETATE
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
INTRAMUSCULAR INJECTION
Maximum Dose
30 mg
Investigational Product Name
EVEROLIMUS
Active Substance
EVEROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
10 mg

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