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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.

Phase 2RecruitingRTOG Foundation, Inc.NCT06955169Data as of May 2026

Treatment: [177Lu]Lu-DOTATATEThis 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.

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Extracted 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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