Neuroendocrine TumorsSALUSNCT03691064
Post-Authorization Long-Term Safety Study of LUTATHERA
An observational study of Neuroendocrine Tumors, run by Advanced Accelerator Applications at 20 sites in 5 countries.
Trial summary
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI). 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?
- LUTATHERA
- How many people
- 1,014 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 28 Nov 2018to 30 Sep 2027
- Phase
- Observational
- 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
Study population: Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.
Who may be able to join
- adult patients (fulfilling the definition of "age of majority" per local regulations),
- with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
- and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).
Who cannot join
- Hypersensitivity to Lutathera (active substance or any of the excipients),
- presence of established or suspected pregnancy or pregnancy not excluded,
- presence of kidney failure with creatinine clearance < 30 mL/min.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United Kingdom10 sites
Novartis Investigative site
Birmingham, B152WB
Novartis Investigative site
Cambridge, CB2 0QC
Novartis Investigative site
Glasgow, G12 OYN
Novartis Investigative site
Liverpool, L7 8XP
Novartis Investigative site
London, NW32QG
Novartis Investigative site
London, SE1 9RT
Novartis Investigative site
London, SE5 9RS
Novartis Investigative site
London, W6 8RF
Novartis Investigative site
Manchester
Novartis Investigative site
Sheffield, S102SJ
United States4 sites
Banner MD Anderson Cancer Center
Phoenix, Arizona, 85006
The Ohio State University Wexner Medical Center
Portland, Ohio, 43210
Oregon Health & Sciences University Hospital
Portland, Oregon, 97339
Virginia Mason in Seattle
Seattle, Washington, 98101
France3 sites
Novartis Investigative site
Clichy
Novartis Investigative site
Lyon
Novartis Investigative site
Villejuif
Spain2 sites
Novartis Investigative site
Majadahonda, Madrid, 28222
Novartis Investigative site
Santiago de Compostela, La Corunya, 15706
Portugal1 site
Novartis Investigative site
Coimbra, Coimbra District, 3000-075
About this study
Official title: International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Read the detailed description
To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.
- Conditions
- Neuroendocrine Tumors
- Being tested
- LUTATHERA
- Keywords
- Gastroenteropancreatic neuroendocrine tumours
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUTATHERADrug
Also called Lu 177 dotatate
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| LUTATHERA | Treated per labeled LUTATHERA dosing regimen. Receives: Drug: LUTATHERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary cancers: incidence of secondary cancers
incidence of secondary cancers
Measured: up to 7 years follow-up
Secondary outcomes (5)
safety profile: incidence of adverse events
incidence of adverse events
Measured: up to 7 years follow-up
mortality
mortality (all cause)
Measured: up to 7 years follow-up
LUTATHERA dose per administration
average dose per administration
Measured: completion of treatment phase (approximately 2 years total)
LUTATHERA total dose
average total dose administered
Measured: completion of treatment phase (approximately 2 years total)
LUTATHERA number of administrations
average number of LUTATHERA doses
Measured: completion of treatment phase (approximately 2 years total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start28 Nov 2018
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Advanced Accelerator Applications
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691064
- Sponsor's protocol ID
- A-LUT-T-E02-402
- Other IDs
- CAAA601A12402, EUPAS25735
- Acronym
- SALUS
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT03691064
- Acronym / sponsor ID
- SALUS / A-LUT-T-E02-402
- Conditions
- Neuroendocrine Tumors
- Keywords
- Gastroenteropancreatic neuroendocrine tumours
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Oct 2018 (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.
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Detailed description
To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUTATHERA | – | Drug: LUTATHERATreated per labeled LUTATHERA dosing regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.
Key inclusion criteria (3 listed)
- adult patients (fulfilling the definition of "age of majority" per local regulations),
- with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
- and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).
Key exclusion criteria (3 listed)
- Hypersensitivity to Lutathera (active substance or any of the excipients),
- presence of established or suspected pregnancy or pregnancy not excluded,
- presence of kidney failure with creatinine clearance < 30 mL/min.
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 |
|---|---|---|
| LUTATHERAAlso: Lu 177 dotatateLabeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses. | Drug | LUTATHERA |
Primary outcome
secondary cancers: incidence of secondary cancers
Time frame: up to 7 years follow-up
incidence of secondary cancers
5 secondary outcomes
safety profile: incidence of adverse events
Time frame: up to 7 years follow-up
mortality
Time frame: up to 7 years follow-up
LUTATHERA dose per administration
Time frame: completion of treatment phase (approximately 2 years total)
LUTATHERA total dose
Time frame: completion of treatment phase (approximately 2 years total)
LUTATHERA number of administrations
Time frame: completion of treatment phase (approximately 2 years total)
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 23 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Advanced Accelerator Applications
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Advanced Accelerator Applications at 20 sites in 5 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 3 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, United States, France, Spain, Portugal. 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.
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?
secondary cancers: incidence of secondary cancers (time frame: up to 7 years follow-up). 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 23 Dec 2025.