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177Lu-DOTATATE

Phase 2

Neuroblastoma Recurrent | Small molecule | Oncology |Novartis AG|Last Updated: Sep 16, 2025

Success Probability

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

177Lu-DOTATATE · 2 trials · 3 indications

Phase 2 2
NCT06326190177Lu-DOTATATE for Recurrent MeningiomaRecurrent Meningioma
RECRUITING136 Analytics
NCT04903899177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk NeuroblastomaNeuroblastoma Recurrent
RECRUITING24 Analytics
PHASE2RECRUITING
177Lu-DOTATATE for Recurrent Meningioma
Recurrent Meningioma
NCT06326190136
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PHASE2RECRUITING
177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
Neuroblastoma Recurrent
NCT0490389924
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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.

Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 1 months after End of Treatment
1 months following end of treatment

Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

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
177Lu-DOTATATEEXPERIMENTALA total of two doses of 177Lu-DOTATATE will be administered intravenously. The minimum time between treatments is 2 weeks.

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 to 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:AustriaFranceNorwaySpainSwitzerlandDenmarkLithuaniaNetherlandsSweden
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Frequently asked questions about 177Lu-DOTATATE

What is 177Lu-DOTATATE used for?

177Lu-DOTATATE is an investigational small molecule being studied for recurrent neuroblastoma and recurrent meningioma. It is in Phase 2 clinical development for these oncology indications. The drug is not approved and remains under investigation in clinical trials.

What does 177Lu-DOTATATE target?

177Lu-DOTATATE targets somatostatin receptors, which are often overexpressed on neuroendocrine and other tumor cells. By binding to these receptors, the drug delivers a radioactive isotope, lutetium-177, directly to cancer cells. This mechanism is being evaluated in Phase 2 trials for recurrent neuroblastoma and recurrent meningioma.

Who makes 177Lu-DOTATATE?

177Lu-DOTATATE is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting Phase 2 clinical trials for the drug in recurrent neuroblastoma and recurrent meningioma. Novartis is responsible for the ongoing clinical development of this investigational therapy.

What phase is 177Lu-DOTATATE in?

177Lu-DOTATATE is in Phase 2 clinical development. It is being studied in two separate Phase 2 trials, one for recurrent neuroblastoma and one for recurrent meningioma. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is 177Lu-DOTATATE in?

177Lu-DOTATATE is being studied in two Phase 2 trials. NCT04903899 is evaluating the drug in children with primary refractory or relapsed high-risk neuroblastoma, with an enrollment of 24. NCT06326190 is studying the drug in recurrent meningioma, with an enrollment of 136. Both trials are currently recruiting.

Is 177Lu-DOTATATE the same as Lutathera?

177Lu-DOTATATE is the same compound as Lutathera, which is approved for certain gastroenteropancreatic neuroendocrine tumors. However, the drug is being investigated in new indications, recurrent neuroblastoma and recurrent meningioma, under the name 177Lu-DOTATATE. These trials are in Phase 2 and the drug remains investigational for these uses.