OncoMatch/Clinical Trials/NCT06326190
177Lu-DOTATATE for Recurrent Meningioma
Is NCT06326190 recruiting? Yes, currently enrolling (May 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
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
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