Neuroendocrine TumorsPhase 3COMPETENCT03049189
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
A Phase 3 study testing 177Lu-edotreotide PRRT, Everolimus and Amino-Acid Solution in people with Neuroendocrine Tumors, run by ITM Solucin GmbH at 52 sites in 14 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 177Lu-edotreotide PRRT, Everolimus and Amino-Acid Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 52 sitesin 14 countries
- Study dates
- 2 Feb 2017to Nov 2029
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.).
Trial locations and contacts
52 sites in 14 countries.
52 sites in 14 countries
Germany11 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Charité - Universitätsmedizin Berlin
Berlin, 10117
Universitätsklinikum Bonn
Bonn, 53127
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Essen
Essen, 45147
University Medical Center, Abteilung für Nuklearmedizin
Hamburg, 20251
Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität
Magdeburg, 39120
Philipps Universität Marburg
Marburg, 35043
Klinikum rechts der Isar Technische Universität München
Munich, 81675
Universitätsklinikum Ulm
Ulm, 89081
Universitätsklinikum Würzburg
Würzburg, 97080
United States6 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Banner Health d.b.a. Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, 77042
Stanford University
Stanford, California, 94305
Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
France6 sites
Hospices civils de Lyon
Bron, 69677
Centre Jean Perrin
Clermont-Ferrand, 63011
HP Hôpital Beaujon
Clichy, 92110
Institut de Recherche en Cancérologie de Montpellier (IRCM)
Montpellier, 34298
CHU de Nantes - Hôtel Dieu
Nantes, 44093
IUCT-Oncopole
Toulouse, 31059
Spain6 sites
Vall d'Hebron University Hospital
Barcelona, 08035
ICO Hospitalet, Granvia de l'Hospitalet
Barcelona, 08909
MD Anderson Cancer Center Madrid
Madrid, 28033
University Hospital 12 de Octubre
Madrid, 28041
Central University Hospital de Asturias (HUCA)
Oviedo, 33011
University and Polytechnic Hospital La Fe
Valencia, 46026
Australia4 sites
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
Heidelberg, Victoria, 3084
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Italy3 sites
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl
Meldola, 47014
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
European Institute of Oncology (EIO)
Milan, 20141
Switzerland3 sites
Universitätsspital Basel
Basel, 4031
Inselspital, Universitätsspital Bern
Bern, 3010
UniversitätsSpital Zürich
Zurich, 8091
United Kingdom3 sites
Royal Free NHS Foundation Trust
London, NW3 2QG
Kings College Hospital
London, SE5 9RS
The Christie NHS Foundation Trust
Manchester, M20 4BX
Belgium2 sites
Institut Jules Bordet
Brussels, 1000
Universitaire Ziekenhuizen Leuven
Leuven, 3000
Czechia2 sites
University Hospital Olomouc
Olomouc, 775 20
University Hospital Motol
Prague, 150 06
Poland2 sites
MSC Memorial Cancer Centre
Gliwice, 44-100
"Gammed" Izabela Chuchrowksa
Warsaw, 02-351
South Africa2 sites
University Cape Town (UCT), Groote Schuur Hospital
Cape Town, 7925
University of Pretoria & Steve Biko Academic Hospital
Pretoria, 0001
Netherlands1 site
Academic Medical Center, University of Amsterdam
Amsterdam, 1100DD
About this study
Official title: 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).
- Conditions
- Neuroendocrine Tumors
- Being tested
- 177Lu-edotreotide PRRT, Everolimus, Amino-Acid Solution
- Keywords
- non-functional and functional P-NET, non-functional GE-NET
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-edotreotide PRRTDrug
Also called 177Lu-DOTATOC, 177Lu-Edo
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
EverolimusDrug
Also called Afinitor
Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
Amino-Acid SolutionOther
Also called Arginine-Lysine 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
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-edotreotide PRRT | Experimental | 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) Receives: Drug: 177Lu-edotreotide PRRT; Other: Amino-Acid Solution |
| Everolimus | Active comparator | 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) Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: From date of randomization until the date of first documented progression or death, assessed up to 30 months,
Secondary outcomes (2)
Objective Response Rate (ORR)
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.
Measured: Up to 30 months
Overall Survival (OS)
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.
Measured: Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start2 Feb 2017
- Primary completion27 Nov 2024
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITM Solucin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ABX CRO, PSI CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049189
- Sponsor's protocol ID
- ITM-LET-01
- Acronym
- COMPETE
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2017
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Walter T, Jann H, Ansquer C, Deshayes E, Garcia-Carbonero R, Teule A, Baum RP, Verberne HJ, Cwikla JB, Srirajaskanthan R, de Mestier L, Grana CM, Buck A, Horsch D, Pavel M, Dierickx LO, Michael M, Strosberg J, Kollar A, Jimenez-Fonseca P, Rinke A, Del Olmo-Garcia M, Flaus A, Hernando J, Kluge A, Breuninger M, Melnyk S, Zhernosekov K, Capdevila J; COMPETE Investigator Team. [177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial. Lancet. 2026 Jul 18;408(10551):234-247. doi: 10.1016/S0140-6736(26)00604-5. Epub 2026 Jul 2.
PubMed 42392118
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03049189
- Acronym / sponsor ID
- COMPETE / ITM-LET-01
- Conditions
- Neuroendocrine Tumors
- Keywords
- non-functional and functional P-NET, non-functional GE-NET
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 324 participants (actual)
- Lead sponsor
- ITM Solucin GmbHIndustry (pharma, biotech, devices)
- Collaborators
- ABX CRO, PSI CRO
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- Nov 2029 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 6 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 177Lu-edotreotide PRRT | Experimental | Drug: 177Lu-edotreotide PRRT, Other: Amino-Acid Solution177Lu-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) |
| Everolimus | Active comparator | Drug: EverolimusEverolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-edotreotide PRRTAlso: 177Lu-DOTATOC, 177Lu-EdoPRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered. | Drug | 177Lu-edotreotide PRRT |
| EverolimusAlso: AfinitorEverolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability. | Drug | Everolimus |
| Amino-Acid SolutionAlso: Arginine-Lysine SolutionThe 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 | 177Lu-edotreotide PRRT |
Primary outcome
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.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42392118Walter T, Jann H, Ansquer C, Deshayes E, Garcia-Carbonero R, Teule A, Baum RP, Verberne HJ, Cwikla JB, Srirajaskanthan R, de Mestier L, Grana CM, Buck A, Horsch D, Pavel M, Dierickx LO, Michael M, Strosberg J, Kollar A, Jimenez-Fonseca P, Rinke A, Del Olmo-Garcia M, Flaus A, Hernando J, Kluge A, Breuninger M, Melnyk S, Zhernosekov K, Capdevila J; COMPETE Investigator Team. [177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial. Lancet. 2026 Jul 18;408(10551):234-247. doi: 10.1016/S0140-6736(26)00604-5. Epub 2026 Jul 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 177Lu-edotreotide PRRT, Everolimus and Amino-Acid Solution in people with Neuroendocrine Tumors, run by ITM Solucin GmbH at 52 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Germany, United States, France, Spain, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From date of randomization until the date of first documented progression or death, assessed up to 30 months,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.