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. This means, that during the study new data will be collected (prospective), that patients are randomly allocated to receive either no-carrier-added Lutetium-177-Edotreotide (n.c.a. ¹⁷⁷Lu-Edotreotide) or the current standard of care (randomized) and that results in patients receiving the investigational treatment are compared to a control group receiving the standard therapy (controlled). Additionally, patients and physicians know which drug is being administered (open-label) and the study is conducted at multiple sites in multiple countries simultaneously (multicenter).

The trial will evaluate the efficacy and safety of the targeted radiopharmaceutical n.c.a. ¹⁷⁷Lu-Edotreotide compared to the standard therapy Everolimus in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs). The treatment option for NETs being investigated in this trial is called Targeted Radionuclide Therapy (also known as Peptide Receptor Radionuclide Therapy / PRRT). It is not to be confused with traditional radiation therapy, which irradiates tumors from the outside of the body.

The primary objective is to demonstrate the efficacy of Targeted Radionuclide Therapy with n.c.a. ¹⁷⁷Lu-Edotreotide to prolong median progression-free survival (mPFS) in patients with inoperable, progressive, somatostatin receptor positive (SSTR⁺) GEP-NETs, compared to Everolimus. Key secondary objectives are to assess objective response rates (ORR), defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, after treatment with n.c.a. ¹⁷⁷Lu-Edotreotide compared to Everolimus and to assess overall survival (OS).

The study is currently being conducted in Europe, North America, South Africa and Australia simultaneously in 12 countries at over 43 sites. The first patient was enrolled and treated in Australia.

300 GEP-NETs patients will be randomized 2:1. Neither the patient nor the doctor will be able to decide which group the patients are in. It is two times more likely that the patient will receive Targeted Radionuclide Therapy with n.c.a. ¹⁷⁷Lu-Edotreotide than the standard therapy with Everolimus.

200 Patients: Targeted Radionuclide Therapy with n.c.a. ¹⁷⁷Lu-Edotreotide with a maximum of 4 cycles, administered as an infusion at 3-monthly intervals for 9 months, or until diagnosis of progression

100 Patients: Everolimus, 10 mg daily, administered orally as a tablet
 

Study Duration
24 months / patient

Study Conduction
Europe, North America, South Africa and Australia, min.12 countries and approx. 43 sites

The following criteria must be fulfilled:

• Male or female ≥ 18 years of age 
• Well-differentiated neuroendocrine tumor of gastroenteric or pancreatic origin (GE-NET), tumor grade G1 or G2, unresectable or metastatic 
• Available existing biopsy specimen from primary tumor or metastasis or, if unavailable, willingness to undergo current biopsy for secondary central analysis
• Measurable disease with ≥ 1 lesion of ≥ 1 cm in diameter, and ≥ 2 radiological tumor lesions in total. A maximum of 5 visible target lesions, not more than 2 lesions per organ 
• Somatostatin receptor positive (SSTR⁺) target lesions and non-target lesions 
• Progressive disease 
• Karnofsky performance status (KPS) scale ≥ 70 
• Life expectancy of at least 6 months 
• Glomerular filtration rate (GFR, MDRD) ≥ 60 mL/min/1.73 m²