Clinical trial · Interventional
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT | Drug | — | UNRESOLVED |
| Amino-Acid Solution | Other | — | UNRESOLVED |
| CAPTEM (Capecitabine and Temozolomide) | Drug | — | UNRESOLVED |
| Everolimus | Drug | Everolimus | ALIAS |
| FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Peptide Receptor Radionuclide Therapy (PRRT) Arm
- interventionNames
- Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
- Other: Amino-Acid Solution
- type
- ACTIVE_COMPARATOR
- label
- CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
- interventionNames
- Drug: CAPTEM (Capecitabine and Temozolomide)
- Drug: Everolimus
- Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥ 18 years. * Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI). * Somatostatin receptor-positive (SSTR+) disease. Exclusion Criteria: * Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin). * Prior (Peptide Receptor Radionuclide Therapy) PRRT. * Any major surgery within 4 weeks prior to randomization in the trial. * Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization. * Other known malignancies. * Serious non-malignant disease. * Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments. * Pregnant or breastfeeding women. * Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
References
Publications (0)
Data not yet available