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

ConditionIntracranial Meningioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRTOG Foundation, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged >= 18 years

Histologically confirmed diagnosis of WHO grade 1-3 meningioma

Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation.

The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation.

Disqualifiers

Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis.

Patients with radiation-associated meningiomas.

Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column. Meningiomas invading the skull base or orbits are not excluded.

Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • [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 intervention

    Treatments will occur at the discretion and based on clinical judgement of the local and treating investigator. Systemic SOC therapy with one of the following agents: bevacizumab, everolimus, or sunitinib.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: [177Lu]Lu-DOTATATEExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Proportion of patients alive without disease progression per current RANO meningioma criteria

Time frame
Assessed up to 4 years

Secondary outcomes

1

Progression free survival at 6 months (PFS-6)

Proportion of participants alive without progression at 6 months assessed per RANO meningioma criteria

Time frame
6 months
2

Overall Survival at 12 months (OS-12)

Proportion of participants alive at 12 months

Time frame
12 months
3

Overall survival (OS)

Proportion of patients after cross-over alive without disease progression per current RANO meningioma criteria

Time frame
Assessed up to 4 years
4

Progression-free Survival after cross-over (PFS2)

Time from cross-over to disease progression per RANO meningioma criteria or death from any cause, whichever occurs first.

Time frame
Assessed up to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RTOG Foundation, Inc.

Lead sponsor

Novartis Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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