OncoMatch/Clinical Trials/NCT06955169
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment
Is NCT06955169 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies [177Lu]Lu-DOTATATE for intracranial meningioma.
Treatment: [177Lu]Lu-DOTATATE — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: SSTR2 overexpression (uptake at least as high as liver in at least one target 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.
Performance status
WHO 0–1
Prior therapy
Cannot have received: SSTR2-targeted therapy (Somatostatin LAR, short-acting Octreotide)
Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide
Cannot have received: peptide receptor radionuclide therapy
Peptide receptor radionuclide therapy at any time prior to registration.
Cannot have received: cytotoxic chemotherapy
Exception: 28 days (or 5 half-lives, whichever is longer) 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
Cannot have received: nitrosoureas
Exception: 6 weeks prior to step 2 registration
6 weeks from nitrosoureas
Cannot have received: external beam radiation, interstitial brachytherapy or stereotactic radiosurgery
Exception: cumulative radiation dose of > 70 Gy or the last dose of radiotherapy < 24 weeks (6 months) prior to step 2 registration
Prior external beam radiation, interstitial brachytherapy or stereotactic radiosurgery cumulative radiation dose of > 70 Gy or the last dose of radiotherapy < 24 weeks (6 months) prior to step 2 registration
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 8 g/dL
Kidney function
Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min
Liver function
Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)
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; 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
- Baptist MD Anderson Cancer Center · Jacksonville, Florida
- Baptist Health Medical Group Oncology · Miami, Florida
- Piedmont Healthcare · Atlanta, Georgia
- Indiana University · Indianapolis, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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