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

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ClinicalTrials.gov Identifier: NCT04919226

Recruitment Status : Recruiting

First Posted : June 9, 2021

Last Update Posted : April 8, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

ITM Solucin GmbH

Tracking Information

First Submitted Date ^ICMJE

June 1, 2021

First Posted Date ^ICMJE

June 9, 2021

Last Update Posted Date

April 8, 2024

Actual Study Start Date ^ICMJE

December 21, 2021

Estimated Primary Completion Date

June 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-Free Survival [ Time Frame: 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. ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Overall Survival [ Time Frame: Up to 2 years after disease progression ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Neuroendocrine Tumors

Intervention ^ICMJE

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 Name: 177Lu-DOTATOC 177Lu-Edo
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.

Other Name: Arginine-Lysine 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.

Study Arms ^ICMJE

Experimental: Peptide Receptor Radionuclide Therapy (PRRT) Arm
Interventions:
- Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
- Other: Amino-Acid Solution
Active Comparator: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
Interventions:
- Drug: CAPTEM (Capecitabine and Temozolomide)
- Drug: Everolimus
- Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

202

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

September 2027

Estimated Primary Completion Date

June 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Nicolas Schneider, Dr		info-solucin@itm-radiopharma.com
Contact: Amanda Rotger, Dr		info-solucin@itm-radiopharma.com

Listed Location Countries ^ICMJE

Australia, France, Germany, India, Italy, Netherlands, Spain, Sweden, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04919226

Other Study ID Numbers ^ICMJE

DP-1111-02CT

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

ITM Solucin GmbH

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

ITM Solucin GmbH

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

ITM Solucin GmbH

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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