Lutetium 177Lu-Edotreotide Versus Best Standard Of Care In Well-differentiated Aggressive Grade-2 And Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

Study Overview

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

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.

N/A

Neuroendocrine Tumors

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

DP-1111-02CT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-06-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-28
First Submitted that Met QC Criteria 2021-06-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-29
First Posted (ACTUAL) 2021-06-09	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Peptide Receptor Radionuclide Therapy (PRRT) Arm	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. 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.
ACTIVE_COMPARATOR: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)	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. 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Peptide Receptor Radionuclide Therapy (PRRT) Arm

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.

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.

ACTIVE_COMPARATOR: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)

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.

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.

Primary Outcome Measures	Measure Description	Time Frame
Progression-Free Survival	PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression.	Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events.

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival	OS (Overall Survival), defined as the time from randomization until death;	Up to 2 years after disease progression

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients aged ≥ 18 years.
Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
Somatostatin receptor-positive (SSTR+) disease.

Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
Prior (Peptide Receptor Radionuclide Therapy) PRRT.
Any major surgery within 4 weeks prior to randomization in the trial.
Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
Other known malignancies.
Serious non-malignant disease.
Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
Pregnant or breastfeeding women.
Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Resources

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Clinical Trial Record