177Lu-Edotreotide versus best standard of care in well-differentiated aggressive G2 and G3 GEP-NETs
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient- reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin receptor-positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE)
IRAS ID
1003685
Contact name
Konstantin Zhernosekov
Contact email
Sponsor organisation
ITM Solucin GmbH
Eudract number
2021-001086-20
Research summary
This Phase 3 study will evaluate the e¬fficacy, safety and impact on the quality of life of Targeted Radionuclide Therapy with the radiopharmaceutical, Lutetium-177-Edotreotide, compared to best standard of care therapy in patients with specific advanced Grade 2 and Grade 3 Gastro-Entero-Pancreatic NeuroEndocrine Tumours (GEP-NETs). Lutetium-177-Edotreotide is injected via a vein into the body and binds to a cell-surface protein called a somatostatin receptor. Neuroendocrine tumour cells often have an increased number of somatostatin receptors. The radioisotope is internalised into the tumour cells where it can selectively destroy them, while healthy tissue surrounding the targeted tumour is minimally affected. The average trial duration for each participant will be approximately four years but may vary on an individual patient basis. There will be a 90-day eligibility screening period, a treatment and follow-up period involving regular hospital visits and a 2-year long term follow-up period. The study will be conducted at about 40 specialist centers across 10 countries, including the UK.
In total, 202 patients will be randomly assigned in a 1:1 ratio to receive either 177Lu-edotreotide or best standard of care therapy.
• 101 patients will receive Targeted Radionuclide Therapy with Lutetium-177-Edotreotide with six cycles, administered as an infusion (second infusion at six weeks, then subsequent infusions at two-month intervals). To protect the kidneys, 30-60 minutes before each cycle, an Amino-Acid Solution will be given as an infusion over 4-6 hours.
• 101 patients will receive best standard of care treatment, i.e. either CAPTEM or everolimus or FOLFOX based on your individual benefit-risk assessment and according to local prescribing information and guidelines. Study assessments include physical examinations, blood and urine samples, questionnaires, electrocardiograms and Computed Tomography or Magnetic Resonance Imaging scans to determine disease status.REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0069
Date of REC Opinion
25 Aug 2021
REC opinion
Further Information Favourable Opinion