Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04919226

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

Sponsor: ITM Solucin GmbH

Conditions Neuroendocrine Tumors

Interventions 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT Amino-Acid Solution CAPTEM (Capecitabine and Temozolomide) Everolimus FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Updated 26 times since 2021 Last updated: Sep 3, 2025 Started: Dec 21, 2021 Primary completion: Jun 30, 2027 Completion: Sep 30, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Neuroendocrine Tumors and is currently ongoing. ITM Solucin GmbH leads this study, which shows 26 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

26 versions recorded

Oct 2025 — Present [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Oct 2025 [monthly]

Active Not Recruiting PHASE3
Jun 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Apr 2025 — Jun 2025 [monthly]

Recruiting PHASE3
Feb 2025 — Apr 2025 [monthly]

Recruiting PHASE3

▶ Show 21 earlier versions

Sep 2024 — Feb 2025 [monthly]

Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE3
May 2024 — Jun 2024 [monthly]

Recruiting PHASE3
Apr 2024 — May 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Apr 2024 [monthly]

Recruiting PHASE3
Oct 2023 — Jan 2024 [monthly]

Recruiting PHASE3
Sep 2023 — Oct 2023 [monthly]

Recruiting PHASE3
Jul 2023 — Sep 2023 [monthly]

Recruiting PHASE3
May 2023 — Jul 2023 [monthly]

Recruiting PHASE3
Apr 2023 — May 2023 [monthly]

Recruiting PHASE3
Mar 2023 — Apr 2023 [monthly]

Recruiting PHASE3
Jan 2023 — Mar 2023 [monthly]

Recruiting PHASE3
Dec 2022 — Jan 2023 [monthly]

Recruiting PHASE3
Sep 2022 — Dec 2022 [monthly]

Recruiting PHASE3
May 2022 — Sep 2022 [monthly]

Recruiting PHASE3
Apr 2022 — May 2022 [monthly]

Recruiting PHASE3
Mar 2022 — Apr 2022 [monthly]

Recruiting PHASE3
Feb 2022 — Mar 2022 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Sep 2021 — Feb 2022 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

ITM Solucin GmbH

Data source: ITM Solucin GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands , Aurora, United States , Bangalore, India , Barcelona, Spain , Berlin, Germany , Bonn, Germany , Boston, United States , Dallas, United States , Durham, United States , Erlangen, Germany and 29 more locations