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177Lu-DOTATATE for Recurrent Meningioma

Study acronym: LUMEN-1
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 12 to 19v8
  2. Study sites: 11 to 12v7
  3. Study sites: 10 to 11v6
  4. Enrollment target: 135 to 136
    • Study sites: 9 to 10
    v5
  5. Study sites: 5 to 9v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 3 to 5v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 6, 2024 to Mar 10, 2025
    • Study sites: 0 to 3
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand. The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area.
Trial Details
NCT Number NCT06326190
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Novartis
Conditions
(from sponsor)		 Recurrent Meningioma
Related terms Meningioma
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov