The phase III clinical trial COMPETE is led as an international, prospective, randomized, controlled, open-label, multicenter (conducted in multiple countries simultaneously) phase III study.
The trial will evaluate the efficacy and safety of the targeted radiopharmaceutical 177Lu-Edotreotide compared with the standard therapy in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET).
The primary objective is to demonstrate the efficacy of PRRT with 177Lu-Edotreotide to prolong median progression-free survival (mPFS) in patients with inoperable, progressive, SSTR+ GEP-NET, compared to Everolimus. Key secondary objectives include the prolongation of duration of disease control (DDC), measured from the time of initial diagnosis of response (SD, PR or CR) until diagnosis of progression, with 177Lu-Edotreotide compared to Everolimus and an increase in objective response rates (ORR), defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, with 177Lu-Edotreotide compared to Everolimus.
The study will be conducted in Europe, North America, South Africa and Australia simultaneously in 12 countries at over 43 sites. The first patient has been enrolled and treated in Australia.
In total, 300 GEP-NET patients will be randomized 2:1 to receive either Targeted Radionuclide Therapy with 177Lu-Edotreotide consisting of a maximum of four cycles (7.5 GBq 177Lu-Edotreotide each), administered as an IV infusion at 3-month intervals for 9 months, or until diagnosis of progression (200 patients), or 10 mg Everolimus daily, administered orally as a tablet until diagnosis of progression (100 patients). Study duration per patient will be 24 months.
The following criteria must be fulfilled:
If you are interested to take part in the COMPETE study, please contact your attending doctor or a participating study center nearby: