drugset / Trial / NCT04919226
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-12-21
- Primary completion
- 2027-06
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-edotreotide | Peptide | — | — |
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Everolimus | Small molecule | — | — |
| Comparator | Leucovorin | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Comparator | Temozolomide | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |