LUMEN-1 (EORTC-2334-BTG)
Research type
Research Study
Full title
[177Lu]Lu-DOTATATE for recurrent MENingioma (LUMEN-1): a randomized phase II study.
IRAS ID
1011837
Contact name
Jelle Stans
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Clinicaltrials.gov Identifier
Research summary
This study will test Lutathera® (which is made of the active drug [177Lu]Lu-DOTATATE) on meningioma that has come back after surgery and/or radiotherapy. Meningiomas are brain tumours that develop in the meninges, the tissue that surrounds and protects the brain and the spinal cord. Most meningiomas contain a receptor called SSTR2. Lutathera® binds to SSTR2 and delivers radiotherapy treatment to these cells killing them whilst sparing normal cells in the body. Hence it is believe that this treatment will be active against most meningiomas.
Currently, if this tumour returns and surgery and/or radiotherapy are not possible the prognostic is not favourable and there are no standard treatment options. Several drugs can be used but the evidence to use them and the results obtained are not yet good enough. Furthermore, all these drugs could have considerable side effects as well.
This study compares Lutathera® to the local standard of care which is either hydroxyurea or supportive care without any active treatment.
We will measure how long each treatment can keep patients alive and without the tumour progressing. This is the main objective of the trial and is called progression free survival. Secondarily, we will also study other measures of efficacy like the response rate of each drug and the quality of life of patients under treatment, as well as measuring the safety of each treatment. If the treatment is with Lutathera®, it will be administered for 4 injections, each one 4 weeks apart. Therefore, the treatment duration is 16 weeks. Patients taking hydroxyurea or who have supportive care only will continue their treatment, for a maximum of 2 years on study, until the tumour progresses, or side effects are considered to be too severe by the patient or the study team. The maximum amount of time on this study is 2 years after the last patient has been enrolled.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0227
Date of REC Opinion
3 Nov 2025
REC opinion
Further Information Favourable Opinion