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

NCT04919226 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2025-09-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT

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

DRUG

CAPTEM (Capecitabine and Temozolomide)

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.

OTHER

Amino-Acid Solution

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

DRUG

Everolimus

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.

DRUG

FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

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.

Sponsors & Collaborators

  • ITM Solucin GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2027-06-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • France
  • Germany
  • India
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919226 on ClinicalTrials.gov