177Lu-DOTATATE for Recurrent Meningioma
ConditionRecurrent Meningioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
About this trial
Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.
The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient ≥ 18 years of age
Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible)
WHO performance status 0-2
Measurable disease (at least 10 x10 mm contrast enhancing lesion) on cranial MRI no more than two weeks prior to randomization
Disqualifiers
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.
Any combined or any prior systemic treatment regardless the timing.
Life expectancy is less than nine weeks.
History of any other invasive malignancy within the last five years (except adequately treated non-melanoma skin cancer, clinically localized and very low-risk prostate cancer, and adequately treated cervical intraepithelial neoplasia)
Trial design
Design model
Parallel
Treatments tested in this trial
Local standard of Care
DrugAccording to local standard practice, treatment or no treatment in the control arm is left to the investigator's discretion.
177Lu-DOTATATE
DrugIntravenous injection of 177Lu-DOTATATE
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Control group: local standard of care (LOC)Active comparator 1 intervention
Group B: Experimental group: 177Lu-DOTATATEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
To examine whether \[177Lu\]Lu-DOTATATE demonstrates sufficient antitumor activity in patients with recurrent meningioma to justify further investigation. Progression-free survival computed based on MRI-based RANO meningioma response criteria as assessed by the local investigator.
Time frame
From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)Secondary outcomes
1
Overall Survival (OS)
Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)
Time frame
From the date of randomization till the date of death (time till death is up to 2 years after patient enrolment in the study)2
Radiological response rate
Best overall response (BOR, defined as CR, MR or PR during study treatment) rate. Complete response (CR) rate is computed by MRI based RANO meningioma response criteria as assessed by the local investigator.
Time frame
From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)3
Radiological response rate
Median best overall response (BOR, defined as CR, MR or PR during study treatment) duration. Median complete response (CR) duration is computed by MRI based RANO meningioma response criteria as assessed by the local investigator.
Time frame
From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)4
The magnitude of change in Health-related quality of life (HRQoL)
The magnitude of change in HRQoL in terms of global health status from EORTC QLQ-C30 during treatment.
Time frame
From the date of randomization regardless of progression status up to 2 years after patient enrolment in the study.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
European Organisation for Research and Treatment of Cancer - EORTC
Lead sponsor
Novartis
Collaborator
Source ClinicalTrials.gov