NCT06955169

Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment

MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: RTOG Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, randomized, phase 2 clinical study to evaluate the efficacy of \[177Lu\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.

Detailed description

Study participants will be randomized by a 2:1 ratio to receive either \[177Lu\]Lu-DOTATATE or standard of care therapy as deemed appropriate by the local investigator. At time of progression, participants on the standard of care arm may cross-over to the \[177Lu\]Lu-DOTATATE alternative treatment arm.

Conditions

• Intracranial Meningioma

Interventions

Type	Name	Description
DRUG	[177Lu]Lu-DOTATATE	The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).
OTHER	Standard of Care treatments	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.

Timeline

• Start date: 2025-12-24
• Primary completion: 2029-08-01
• Completion: 2030-08-01
• First posted: 2025-05-02
• Last updated: 2026-04-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study