Recruiting
Phase 2

\[177Lu\]Lu-DOTATATE

Sponsor:

RTOG Foundation, Inc.

Code:

NCT06955169

Conditions

Intracranial Meningioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[177Lu]Lu-DOTATATE

Standard of Care treatments

Study Details

Brief 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.

Conditions

Intracranial Meningioma

Study ID

NCT06955169

Start date

Aug 24, 2025

Status verified date

Sep, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

STEP 1 REGISTRATION

  • 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.
  • 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 two or more axial slices (≤ 5 mm interslice thickness, ≤ 1 mm interslice gap) per current RANO meningioma criteria
  • Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as:
  • ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or
  • ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or
  • Development of a new measurable lesion
  • The following scans must be available for submission for central radiology review:
  • Pre-progression gadolinium-enhanced MRI brain scan no older than 12 months (379 days) that serves as a reference for evaluation of radiographic disease progression
  • Progression gadolinium-enhanced MRI brain scan

STEP 2 REGISTRATION

  • Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as:
  • ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or
  • ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or
  • Development of a new measurable lesion.
  • \[68Ga\]Ga-DOTATATE uptake on PET-CT. Positive uptake is defined as uptake at least as high as liver, based on the uptake in at least one target lesion.
  • Both the patient and investigator must agree that the patient will NOT receive SSTR2-targeted therapy, surgical resection, or radiation therapy until progression of disease while on study treatment.
  • Patients must be willing and able to undergo regular MRI scans of the brain and \[68Ga\]Ga-DOTATATE PET-CT imaging during the study.
  • Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).
  • Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration):
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • Platelet count ≥ 75,000/mm3
  • Hemoglobin ≥ 8 g/dL
  • Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min
  • AST (SGOT) and ALT (SGPT) ≤ 3 x the laboratory upper limit of normal (ULN)
  • Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)
  • Potassium within normal limits.

Exclusion Criteria:

  • 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.
  • Unstable neurological symptoms requiring steroids to control symptoms at a dose of >2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration.
  • Patients requiring immediate local therapy (e.g. surgical resection).
  • Surgical procedure within the timeframes listed below, prior to step 2 registration.
  • 28 days from any prior craniotomy
  • 7 days from stereotactic biopsy Note: There is no limit to the number of prior surgical interventions
  • Treatment within the timeframes specified below, prior to step 2 registration.
  • 28 days (or 5 half-lives, whichever is longer) for cytotoxic chemotherapy, biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma
  • 6 weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.
  • A target lesion is excluded if it has received any of the following:
  • More than 2 total prior courses of radiation
  • More than 1 prior course of standard fractionated external beam radiation therapy (EBRT)
  • Radiation treatment to the target lesion completed <24 weeks (168 days) before Step 2 registration.

For purposes of this criterion, one course of EBRT counts as one course regardless of duration, and each course of stereotactic radiation (1-5 fractions) counts as one course. Accordingly, a target lesion may have received at most one prior course of EBRT plus one prior course of stereotactic radiation, or two prior courses of stereotactic radiation. Prior radiation history must be evaluated on a lesion-by-lesion basis, including radiation delivered before any subsequent surgical resection.

  • All types of radioligand therapy at any time prior to registration. Radioligands received for diagnostic purposes are not exclusionary.
  • Known hypersensitivity to somatostatin analogues or any component of the \[68Ga\]Ga- DOTATATE or \[177Lu\]Lu-DOTATATE formulations.
  • Active infection requiring current use of intravenous therapy with antibiotics.
  • Active cardiovascular disease: cerebral vascular accident/stroke (≤ 6 months prior to registration), myocardial infarction (≤ 6 months prior to registration), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.
  • An active malignancy ≤ 3 years. Note: Patients with a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Pregnant and/or breastfeeding patients who are unwilling to discontinue breast feeding.
  • Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: [177Lu]Lu-DOTATATE

Study participants receive \[177Lu\]Lu-DOTATATE

other: Control

Study participants receive systemic Standard of Care (SOC) Therapy. Control Arm participants crossover to \[177Lu\]Lu-DOTATATE at progression

Interventions

[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).

Standard of Care treatments

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.

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: Assessed up to 4 years ]

Central Contacts and Locations

Central contacts

Sylvia C Kurz, MD,PhD

203-785-5616Sylvia.Kurz@yale.edu

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Manisha Dandekar

mdandeka@hs.uci.edu

Principal Investigator:

Daniela Bota, MD, PhD

University of California San Diego - Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Mohammad Amjad

mtamjad@health.ucsd.edu

Principal Investigator:

Jona Hattangadi-Gluth, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Amy Rodrigues, CCRC

203-260-9632amy.rodrigues@yale.edu

Principal Investigator:

Sylvia Kurz, MD, PhD

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

CTOinterest@bmcjax.com

Principal Investigator:

Michael Olson, MD PhD

University of Miami

Recruiting

Miami, Florida, United States, 33146

Contacts

Lily Friedman

lxf699@med.miami.edu

Principal Investigator:

Marina Kushnirsky, MD

Baptist Health Medical Group Oncology

Recruiting

Miami, Florida, United States, 33176

Contacts

Nicolas Morales

nicolas.morales1@baptisthealth.net

Principal Investigator:

Matthew Hall, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33543

Contacts

Abdullah Abdelkawy

Abdullah.abdelkawy@Moffitt.org

Principal Investigator:

Andre Luiz Beer Furlan, MD, PhD

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Jeff Whorton, BSN,RN

jeff.whorton@piedmont.org

Principal Investigator:

Adam Nowlan, MD, MPH

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lauren Perrey-Moore, RN

lperry@iu.edu

Principal Investigator:

Kathryn Nevel, MD

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Kristin West, RN, BSN

kristin-gaimari-varner@uiowa.edu

Principal Investigator:

Kristin Plichta, MD, PhD

Dana-Farber/Harvard Cancer Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Kathryn Partridge

Kathryn_Partridge@DFCI.HARVARD.EDU

Principal Investigator:

Gilbert Youssef, MD

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jen Thomas

jennifkt@med.umich.edu

Principal Investigator:

Sean Miller, MD

NYU Lagone Health

Recruiting

New York, New York, United States, 10016

Contacts

Olga Garduno-Ortega

Olga.Garduno-Ortega@nyulagone.org

Principal Investigator:

Marissa Barbaro, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 22708

Contacts

Kelly Moulton

kelly.moulton@duke.edu

Principal Investigator:

Margaret Johnson, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Wathoo Chetna

cwathoo@mdanderson.org

Principal Investigator:

Carlos Kamiya-Matsuoka, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Bailee Fritz

bfritz@mcw.edu

Principal Investigator:

Michael Straza, MD

More Information

Sponsor

RTOG Foundation, Inc.

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • MOMENTUM-1
  • Meningioma
  • Advanced Intracranial Meningioma
  • SSTR2
  • Radiopharmaceuticals
  • Theranostics
  • Radioligand Therapy
  • Lu-DOTATATE
  • Lutathera

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RTOG Foundation, Inc. on 2026-09-08.