Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)

March 17, 2026 updated by: ITM Solucin GmbH

A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Locations

  • Australia
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus Wien
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
  • Czechia
      • Olomouc, Czechia, 775 20
        • University Hospital Olomouc
      • Prague, Czechia, 150 06
        • University Hospital Motol
  • France
      • Bron, France, 69677
        • Hospices Civils de Lyon
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Clichy, France, 92110
        • HP Hôpital Beaujon
      • Montpellier, France, 34298
        • Institut de Recherche en Cancérologie de Montpellier (IRCM)
      • Nantes, France, 44093
        • CHU de Nantes - Hôtel Dieu
      • Toulouse, France, 31059
        • IUCT-Oncopole
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Erlangen, Germany, 91054
        • Universitatsklinikum Erlangen
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
      • Hamburg, Germany, 20251
        • University Medical Center, Abteilung für Nuklearmedizin
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität
      • Marburg, Germany, 35043
        • Philipps Universität Marburg
      • Munich, Germany, 81675
        • Klinikum rechts der Isar Technische Universität München
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
  • Italy
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20141
        • European Institute of Oncology (EIO)
  • Netherlands
      • Amsterdam, Netherlands, 1100DD
        • Academic Medical Center, University of Amsterdam
  • Poland
      • Gliwice, Poland, 44-100
        • MSC Memorial Cancer Centre
      • Warsaw, Poland, 02-351
        • "Gammed" Izabela Chuchrowksa
  • South Africa
      • Cape Town, South Africa, 7925
        • University Cape Town (UCT), Groote Schuur Hospital
      • Pretoria, South Africa, 0001
        • University of Pretoria & Steve Biko Academic Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Vall d'Hebron University Hospital
      • Barcelona, Spain, 08909
        • ICO Hospitalet, Granvia de l'Hospitalet
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Madrid
      • Madrid, Spain, 28041
        • University Hospital 12 de Octubre
      • Oviedo, Spain, 33011
        • Central University Hospital de Asturias (HUCA)
      • Valencia, Spain, 46026
        • University and Polytechnic Hospital La Fe
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitatsspital Basel
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern
      • Zurich, Switzerland, 8091
        • Universitatsspital Zurich
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free NHS Foundation Trust
      • Manchester, United Kingdom, M20 4BX
        • The Christie Nhs Foundation Trust
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner Health d.b.a. Banner MD Anderson Cancer Center
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Texas
      • Houston, Texas, United States, 77042
        • Excel Diagnostics & Nuclear Oncology Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
  • Measurable disease per RECIST 1.1
  • Somatostatin receptor positive (SSTR+) disease
  • Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)

Exclusion Criteria:

  • Known hypersensitivity to edotreotide or everolimus
  • Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
  • Prior exposure to any peptide receptor radionuclide therapy (PRRT)
  • Prior therapy with mTor inhibitors
  • Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
  • Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
  • Indication for surgical lesion removal with curative potential
  • Planned alternative therapy (for the period of study participation)
  • Serious non-malignant disease
  • Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
  • Pregnant or breast-feeding women
  • Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 177Lu-edotreotide PRRT

177Lu-edotreotide (177Lu-DOTATOC)

A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each.

Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
Drug: 177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Other Names:
  • 177Lu-DOTATOC
  • 177Lu-Edo
Other: Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
Other Names:
  • Arginine-Lysine Solution
Active Comparator: Everolimus

Everolimus (Afinitor ®)

Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
Drug: Everolimus
Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
Other Names:
  • Afinitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From date of randomization until the date of first documented progression or death, assessed up to 30 months,
PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.
From date of randomization until the date of first documented progression or death, assessed up to 30 months,

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 30 months
ORR will be assessed, defined as the proportion of participants achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus.
Up to 30 months
Overall Survival (OS)
Time Frame: Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS)
From the date of randomisation until the date of death up to the up to the end of the 5 year post-study follow-up.
Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ITM Solucin GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ABX CRO
PSI CRO

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITM-LET-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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