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Lutathera under the microscope: how does it perform in real patients?

NCT ID NCT04727723

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 164 adults with advanced, progressive neuroendocrine tumors of the gut or pancreas who were treated with Lutathera (a radioactive drug) in normal hospital settings. Researchers measured how long patients lived without their cancer getting worse and how many tumors shrank. The goal is to see if Lutathera works as well in everyday practice as it did in earlier clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lutathera (177Lu-oxodotreotide)
What this could lead to
If results are positive, this could confirm that Lutathera works well in everyday clinical practice for controlling advanced GEP-NETs, potentially improving treatment guidelines.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. The study is also completed, meaning findings are already known and may not lead to new breakthroughs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

164 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study plans to enroll patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs.

Ages

18 to 100 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent must be obtained prior to any data collection. * Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET). * Aged ≥18 years. * Patients must be naïve to treatment with Lutathera® at enrolment. Exclusion Criteria: * Participation in a current or prior investigational study within 30 days preceding enrolment or within 5 half-lives of the investigational product, whichever is longer.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine neoplasm digestive system neuroendocrine tumor, grade 1/2 neuroendocrine neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroenteropancreatic neuroendocrine tumor

Contacts and locations

Locations

  • Novartis Investigative Site

    Alessandria, Italy

  • Novartis Investigative Site

    Bologna, Italy

  • Novartis Investigative Site

    Brescia, Italy

  • Novartis Investigative Site

    Cona, Italy

  • Novartis Investigative Site

    Florence, Italy

  • Novartis Investigative Site

    Latina, Italy

  • Novartis Investigative Site

    Meldola, Italy

  • Novartis Investigative Site

    Messina, Italy

  • Novartis Investigative Site

    Milan, Italy

  • Novartis Investigative Site

    Naples, Italy

  • Novartis Investigative Site

    Negrar, Italy

  • Novartis Investigative Site

    Padova, Italy

  • Novartis Investigative Site

    Pisa, Italy

  • Novartis Investigative Site

    Reggio Emilia, Italy

  • Novartis Investigative Site

    Rionero in Volture, Italy

  • Novartis Investigative Site

    Roma, Italy

  • Novartis Investigative Site

    Rozzano, Italy

  • Novartis Investigative Site

    Torino, Italy

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