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COMPOSE Clinical Trial Design
COMPOSE (ClinicalTrials.gov Identifier: NCT04919226) is an international, prospective, randomized, controlled, open-label, multicenter phase III clinical study to evaluate the efficacy, safety and impact on quality of life of Targeted Radionuclide Therapy (Peptide Receptor Radionuclide Therapy / PRRT) with no-carrier-added lutetium-177-edotreotide (n.c.a. 177Lu-edotreotide) compared to a standard therapy with either CAPTEM or everolimus or FOLFOX, in patients with well-differentiated advanced grade 2 and grade 3, somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (G2 and G3 GEP-NETs).
N.c.a. 177Lu-edotreotide is a radiolabeled somatostatin analogue that specifically binds to SSTR-expressing tumor cells, e.g. neuroendocrine tumor cells. The standard of care treatment will be determined by the study doctor based on individual risk‑benefit assessment and according to local prescribing information and guidelines.
The primary objective of COMPOSE is to demonstrate the efficacy of Targeted Radionuclide Therapy with n.c.a. 177Lu-edotreotide in the treatment of advanced grade 2 (G2; Ki67 between 15 and 20, both inclusive) and grade 3 (G3; Ki-67 above 20 up to 55, inclusive) SSTR+ GEP-NETs compared to best standard of care treatment with either CAPTEM or everolimus or FOLFOX. Key secondary objectives are to assess objective response rates (ORR) as best outcome, overall survival (OS), safety and impact on quality of life.
The study is being conducted predominantly in Europe, North America, India and Australia, in approximately 10 countries and 40 sites. The full list of all participating centers is provided under Participating Sites.
In 2014, the EMA and in 2015 the FDA granted n.c.a. 177Lu-edotreotide orphan drug designation for the treatment of GEP-NETs. In 2016, a retrospective phase II efficacy and safety study of Targeted Radionuclide Therapy with n.c.a. 177Lu-edotreotide in patients with advanced NETs was performed. The results show a median PFS and an overall survival of 17.4 and 34.2 months, respectively, for all NETs.* These favorable data together with the positive long-term experience from compassionate use underline the high potential of n.c.a. 177Lu-edotreotide. With the ongoing phase III studies COMPETE and COMPOSE, ITM aims to further verify these results and the major potential of n.c.a. 177Lu-edotreotide as a new treatment option for GEP-NETs.
* Baum et al., February 2016, Theranostics Vol. 6(4), pp. 501-510
Company Information
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life.
