Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06955169 | Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment | PHASE2 | RECRUITING | 153 | — | — | Dec 24, 2025 | Aug 1, 2030 | May 14, 2026 | 12 | United States |
PFS defined as the time from randomization to date of disease progression per current RANO meningioma criteria or death, whichever occurs first
| Arm | Type | Description |
|---|---|---|
| [177Lu]Lu-DOTATATE | EXPERIMENTAL | Study participants receive \[177Lu\]Lu-DOTATATE |
| Control | OTHER | Study participants receive Local Standard of Care (SOC) Therapy. Control Arm participants crossover to \[177Lu\]Lu-DOTATATE at progression |
| Name | Type | Description |
|---|---|---|
| [177Lu]Lu-DOTATATE | DRUG | The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days). |
| Standard of Care treatments | OTHER | Treatments will occur at the discretion and based on clinical judgement of the local and treating investigator. Local SOC therapy with one of the following agents: bevacizumab, everolimus, hydroxyurea, or sunitinib. |
Inclusion Criteria: STEP 1 REGISTRATION * Aged \>= 18 years * Histologically confirmed diagnosis of WHO grade 1-3 meningioma * Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan defined as at least one lesion with two perpendicular diameters measuring ≥10 mm on...