OncoMatch/Clinical Trials/NCT06326190
177Lu-DOTATATE for Recurrent Meningioma
Is NCT06326190 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Local standard of Care and 177Lu-DOTATATE for recurrent meningioma.
Treatment: Local standard of Care · 177Lu-DOTATATE — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Other
Disease stage
Grade: 123 (WHO CNS5)
all grades, 1-3 per WHO CNS5, are eligible
Performance status
WHO 0–2
Prior therapy
Must have received: surgery — for meningioma
At least one prior surgery ... for meningioma
Must have received: external beam radiotherapy — for meningioma
one line of external beam radiotherapy for meningioma
Cannot have received: systemic treatment
Any combined or any prior systemic treatment regardless the timing.
Lab requirements
Blood counts
Neutrophils 1.5 x 10^9/L, hemoglobin 9 g/dL or 5.6 mmol/L, platelets 100 x 10^9/L
Kidney function
Serum creatinine 1.5 x ULN, Creatinine clearance > 40 ml/min as calculated by CKD-EPI 2021
Liver function
Total Bilirubin 1 x ULN, SGPT/ALT and SGOT/AST 2.5 x ULN, Albumin 30 g/L
Adequate liver, renal and haematological function within four weeks prior to randomization (1) Neutrophils 1.5 x 10^9/L, hemoglobin 9 g/dL or hemoglobin 5.6 mmol/L, platelets 100 x 10^9/L, (2) Total Bilirubin 1 x ULN, SGPT/ALT and SGOT/AST 2.5 x ULN, (3) Albumin 30 g/L, (4) Serum creatinine 1.5 x ULN, (5) Creatinine clearance > 40 ml/min as calculated by CKD-EPI 2021
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06326190 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic treatment disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify