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177Lu-DOTATATE

Phase 2

Recurrent Meningioma | Small molecule | Other |Novartis AG|Last Updated: Sep 16, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06326190177Lu-DOTATATE for Recurrent MeningiomaPHASE2 RECRUITING 136 — — Mar 10, 2025Dec 22, 2028Sep 16, 202512 Austria, France +3
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS)
From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)

To examine whether \[177Lu\]Lu-DOTATATE demonstrates sufficient antitumor activity in patients with recurrent meningioma to justify further investigation. Progression-free survival computed based on MRI-based RANO meningioma response criteria as assessed by the local investigator.

Secondary Endpoints
Overall Survival (OS)
From the date of randomization till the date of death (time till death is up to 2 years after patient enrolment in the study)
Radiological response rate
From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)
The magnitude of change in Health-related quality of life (HRQoL)
From the date of randomization regardless of progression status up to 2 years after patient enrolment in the study.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Control group: local standard of care (LOC)ACTIVE_COMPARATORAccording to local standard practice, treatment in the control arm is left to the investigator's discretion. * Hydroxyurea * Bevacizumab * Sunitinib * Octreotide (Sandostatin LAR) * Everolimus * No treatment (observation with regular follow-up and best supportive care)
Experimental group: 177Lu-DOTATATEEXPERIMENTALPatients will receive 177Lu-DOTATATE with a total dose of 7.4 GBq/cycle every four (4) weeks for four (4) cycles as an IV infusion
Interventions
NameTypeDescription
Local standard of CareDRUGAccording to local standard practice, treatment or no treatment in the control arm is left to the investigator's discretion.
177Lu-DOTATATEDRUGIntravenous injection of 177Lu-DOTATATE
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Adult patient ≥ 18 years of age * Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible) * WHO performance status 0-2 * Measurable disease (at least 10 x10 mm contrast enhancing lesion) on cranial MRI no more than two weeks prior to rando...

Countries:AustriaFranceNorwaySpainSwitzerland
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