- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07653126
A Study of Peptide Receptor Radionuclide Therapy (PRRT) Use in Neuroendocrine Tumor (NET) Patients in Germany (LUNET-2)
June 12, 2026 updated by: Novartis Pharmaceuticals
Use of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumour (NET) Patients in Germany - A Retrospective Evaluation in German Centers for NET (LUNET-2 Study)
The aim of this study was to assess patient characteristics and treatment patterns of gastro-enteropancreatic neuroendocrine tumor (GEP-NET) patients who received PRRT in German routine care.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
117
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
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Essen, Germany
- Novartis Investigative Site
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Heidelberg, Germany
- Novartis Investigative Site
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München, Germany
- Novartis Investigative Site
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Rostock, Germany
- Novartis Investigative Site
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Stuttgart, Germany
- Novartis Investigative Site
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Tübingen, Germany
- Novartis Investigative Site
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Würzburg, Germany
- Novartis Investigative Site
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult GEP-NET patients in Germany who received their first cycle of primary PRRT between 01 July 2020 and 30 June 2021.
Description
Inclusion criteria:
- Patients with a confirmed diagnosis of GEP-NET (any localization of the primary tumor including cancer of unknown primary origin [CUP], any Grade).
- Patients with a first cycle of primary PRRT of home-brew 177Lu-DOTATATE/DOTATOC or Lutathera® between 01 July 2020 and 30 June 2021.
Exclusion criteria:
- Received a combination of PRRT with chemotherapy.
- Received a combination of PRRT with a radionuclide other than lutetium-177 (e.g., yttrium-90).
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
Cohorts and Interventions
Group / Cohort |
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PRRT Cohort
Adult GEP-NET patients who received PRRT in German routine care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Baseline Demographics
Time Frame: Baseline
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Baseline
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Number of Patients by Tumor Status
Time Frame: Baseline
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Baseline
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Duration Between Initial Diagnosis and Initiation of Primary PRRT
Time Frame: Baseline
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Baseline
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Number of Patients by PRRT Line of Therapy
Time Frame: Approximately 1 year
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Approximately 1 year
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Number of Patients by Type of PRRT Received
Time Frame: Approximately 1 year
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Approximately 1 year
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PRRT Dosage
Time Frame: Approximately 1 year
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Approximately 1 year
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Number of Patients by Treatment Interval
Time Frame: Approximately 1 year
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Approximately 1 year
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Number of Patients by Co-medication
Time Frame: Approximately 1 year
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Approximately 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
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)
April 3, 2023
Primary Completion (Actual)
September 29, 2023
Study Completion (Actual)
September 29, 2023
Study Registration Dates
First Submitted
June 12, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 17, 2026
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAA601A1DE01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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