Neuroendocrine TumorsPhase 3COMPOSENCT04919226
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
A Phase 3 study testing 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide) and Amino-Acid Solution in people with Neuroendocrine Tumors, run by ITM Solucin GmbH at 42 sites in 10 countries.
Trial 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… 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 (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide) and Amino-Acid Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 42 sitesin 10 countries
- Study dates
- 21 Dec 2021to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
42 sites in 10 countries.
42 sites in 10 countries
United States14 sites
University of Colorado Hospital, Nuclear Medicine
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Texas Oncology
Dallas, Texas, 75246
Duke University School of Medicine, Duke Cancer Institute
Durham, North Carolina, 27710
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute
New York, New York, 10128
Stanford Cancer Center
Palo Alto, California, 94305
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Oregon Health and Science University
Portland, Oregon, 97239-3098
Mayo Clinic - Rochester, Department of Oncology
Rochester, Minnesota, 55905
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Washington University Alvin J. Siteman Cancer Center
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Spain7 sites
University Hospital Vall d'Hebron, Department of Medical Oncology
Barcelona, 08035
ICO Hospitalet, Catalan Institute of Oncology
Barcelona, 199-203
University General Hospital Gregorio Maranon
Madrid, 28007
University Hospital 12 de Octubre, Department of Gastroenterology
Madrid, 28041
Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology
Oviedo, 33011
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, 15706
University and Polytechnic Hospital La Fe, Endocrinology
Valencia, 46026
France4 sites
Edouard Herriot Hospital, Medical Oncology Unit
Lyon, 69003
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, Cedex, 44093
Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology
Pessac, Bordeaux, 33604
IUCT Oncopole - Institut Universitaire du Cancer de Toulouse
Toulouse, 31059
Germany4 sites
Charite - University Hospital Berlin
Berlin, 13353
University Hospital Bonn, Department of Nuclear Medicine
Bonn, 53127
University Hospital Erlangen, Department of Internal Medicine I - Endocrinology
Erlangen, 91054
University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine
Essen, 45147
India3 sites
HCG Cancer Centre, Medical Oncology
Bangalore, Karnataka, 560027
Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging
Mumbai, 400012
All India Institute Of Medical Sciences, Nuclear Medicine
New Delhi, National Capital Territory of Delhi, 110029
Italy3 sites
University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine
Messina, 98125
European Institute of Oncology (IEO), IRCCS
Milan, 20141
University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology
Rome, 00168
Australia2 sites
Peter MacCallum Cancer Centre
Melbourne, Victoria, VIC 3000
Royal North Shore Hospital
St Leonards, New South Wales, 2065
China2 sites
Fudan University Shanghai Cancer Center
Shanghai, 200000
Affiliated Hospital of Jiangnan University
Wuxi, 214122
Netherlands2 sites
VU Medical Center (VUMC), Department of Medical Oncology
Amsterdam, 1081-HV
Erasmus University Medical Center Rotterdam
Rotterdam, 3015 GD
About this study
Official title: 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
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
- Neuroendocrine Tumors
- Being tested
- 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide), Amino-Acid Solution, Everolimus, FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
- Keywords
- GastroEnteroPancreatic, non-functional and functional GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NET)
- Medical subject headings
- Neuroendocrine Tumors, Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRTDrug
Also called 177Lu-DOTATOC 177Lu-Edo
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
CAPTEM (Capecitabine and Temozolomide)Drug
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.
Amino-Acid SolutionOther
Also called Arginine-Lysine 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.
EverolimusDrug
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.
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)Drug
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 group | Role | What they receive |
|---|---|---|
| Peptide Receptor Radionuclide Therapy (PRRT) Arm | Experimental | Not described Receives: Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT; Other: Amino-Acid Solution |
| CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) | Active comparator | Not described Receives: Drug: CAPTEM (Capecitabine and Temozolomide); Drug: Everolimus; Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 or death, whichever occurs first.
Measured: 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 outcomes (1)
Overall Survival
OS (Overall Survival), defined as the time from randomization until death;
Measured: Up to 3 years after disease progression, or to a maximum of 5 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start21 Dec 2021
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITM Solucin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919226
- Sponsor's protocol ID
- DP-1111-02CT
- Acronym
- COMPOSE
- Status last verified
- Sep 2025
- First submitted
- 1 Jun 2021
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04919226
- Acronym / sponsor ID
- COMPOSE / DP-1111-02CT
- Conditions
- Neuroendocrine Tumors
- Keywords
- GastroEnteroPancreatic, non-functional and functional GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NET)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 259 participants (actual)
- Lead sponsor
- ITM Solucin GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peptide Receptor Radionuclide Therapy (PRRT) Arm | Experimental | Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, Other: Amino-Acid Solution |
| CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) | Active comparator | Drug: CAPTEM (Capecitabine and Temozolomide), Drug: Everolimus, Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 (Peptide Receptor Radionuclide Therapy) PRRTAlso: 177Lu-DOTATOC 177Lu-EdoPeptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered. | Drug | Peptide Receptor Radionuclide Therapy (PRRT) Arm |
| 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 | CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) |
| Amino-Acid SolutionAlso: Arginine-Lysine SolutionThe Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution. | Other | Peptide Receptor Radionuclide Therapy (PRRT) Arm |
| EverolimusBest 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 | CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) |
| 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. | Drug | CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) |
Primary outcome
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 or death, whichever occurs first.
1 secondary outcome
Overall Survival
Time frame: Up to 3 years after disease progression, or to a maximum of 5 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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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.
42 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, CAPTEM (Capecitabine and Temozolomide) and Amino-Acid Solution in people with Neuroendocrine Tumors, run by ITM Solucin GmbH at 42 sites in 10 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 3 inclusion and 9 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Spain, France, Germany, India and 5 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?
This study is still under way. Results are not available in the source record yet.
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 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.