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Edotreotide lutetium LU-177

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Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT

Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

CAPTEM (Capecitabine and Temozolomide)

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

Amino-Acid Solution

FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Nicolas Schneider, Dr

Amanda Rotger, Dr

Carina Aparici

Bennett Chin

Jonathan Strosberg

Kimberly Perez

Thorvardur Halfdanarson

Vikas Prasad

Nithya Raj, MD

Edward Wolin

Michael Morse

Guillaume Pegna

Namrata Vijayvergia

Scott Paulson, M.D.

Daniel Halperin, MD

Heloisa Soares

David Chan

Michael Michael

Denis Smith

Catherine Ansquer

Thomas Walter

Dierickx Lawrence, MD

Henning Jann

Markus Essler

Marianne Pavel

Ken Herrmann

Sergio Baldari

Nicola Fazio

Giovanni Schinzari

Willemien Menke-van der Houven van Oord

Jaume Capdevila

Alexandre Vega

Gabriela Torres Perez-Solero

Rocio Garcia Carbonero

Paula Fonseca

Virginia Pubul

Angel Segura

Rajaventhan Srirajaskanthan

The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin

PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression.

OS (Overall Survival), defined as the time from randomization until death;

ITM Solucin GmbH

Spots Global Cancer Trial Database for folfox (folinic acid + fluorouracil + oxaliplatin)