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177Lu-Edotreotide versus best standard of care in well-differentiated aggressive G2 and G3 GEP-NETs
177Lu-Edotreotide (synonyms: Lutetium (177Lu) Edotreotide; 177Lu-DOTATOC) was first reported in 2005 (Forrer et al., 2005) as an innovative PRRT agent with a favourable safety profile and promising efficacy. 177Lu-Edotreotide is currently under development for the treatment of neuroendocrine tumours (NETs) with a focus on well-differentiated SSTR+, gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs). According to the 2017 World Health Organization (WHO) Grading System, well-differentiated Pancreatic Neuroendocrine Neoplasms are composed of cells showing minimal to moderate atypia, lack necrosis, express general markers of neuroendocrine differentiation and are classified into tumour grades 1, 2 and 3, as defined by Ki-67 Index <3, 3-20 and >20, respectively (Choe et al., 2019).
A prospective, randomised, controlled, open-label, multicentre, Phase III study is currently ongoing to evaluate the efficacy and safety of PRRT with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, SSTR+, GEP-NETs (COMPETE Study).1 The COMPETE study restricts enrolment to patients with a histologically-confirmed diagnosis of well-differentiated NETs of non-functional gastroenteric origin (GE-NET) or both functional and non-functional pancreatic origin (P-NET), tumour grade G1 or G2 (Ki-67 ≤20%), considered unresectable or metastatic.
The current COMPOSE study is designed to demonstrate the efficacy of PRRT with 177Lu-Edotreotide compared to best standard of care (investigator’s choice [among the protocol comparator list]) in patients with a histologically-confirmed diagnosis of well-differentiated aggressive G2 (15 < Ki‑67 ≤20) and Grade 3 (20 < Ki-67 ≤ 55) GEP-NETs, who are eligible to receive either CAPTEM (capecitabine-temozolomide), FOLFOX (folinic acid, fluorouracil and oxaliplatin) or Everolimus (at least one of them). Patients with functional and non-functional GEP-NETs will be enrolled indifferently. In addition, safety and quality of life (QoL) will also be evaluated in the study.
COMPOSE – DP-1111-02
ITM Solucin GmbH, Germany
Well-differentiated aggressive G2 and G3 GEP-NETs
Prospective, randomised (1:1), controlled, open-label, multi-centre, international, Phase III study.
Phase III study
A total of 220 patients will be randomised into the study (see Rationale for Number of Patients below).
Investigateur principal pour la France : Thomas Walter (Lyon)
Centres français: Lyon, Nantes, Toulouse, Bordeaux …
To demonstrate the efficacy of PRRT with 177Lu-Edotreotide in the treatment of aggressive G2 (15 < Ki‑67 ≤ 20) and Grade 3 (20 < Ki-67 ≤ 55) SSTR+ GEP-NETs compared to best standard of care (investigator’s choice [among the protocol comparator list]).