Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Promising drug combo shows hope for slowing rare gut tumors

NCT ID NCT03972488

Disease control Sponsor: Advanced Accelerator Applications 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding Lutathera to standard octreotide treatment can delay tumor growth in people with advanced neuroendocrine tumors of the stomach, intestines, or pancreas. The trial involved 226 patients with fast-growing tumors (grades 2 and 3) who had not received prior treatment. Results focus on how long the cancer stays under control and tumor shrinkage rates.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

226 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Oct 2027

An estimate. End dates often move.

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, well differentiated Grade 2 or Grade 3 gastroenteropancreatic neuroendocrine (GEP-NET) tumor diagnosed within 6 months prior to screening. * Ki67 index ≥10 and ≤ 55% * Patients ≥ 15 years of age and a body weight of \> 40 kg at screening * Expression of somatostatin receptors on all target lesions documented by CT/MRI scans, assessed by any of the following somatostatin receptor imaging (SRI) modalities within 3 months prior to randomization: \[68Ga\]-DOTA-TOC (e.g. Somakit-TOC®) PET/CT (or MRI when applicable based on target lesions) imaging, \[68Ga\]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging (e.g. NETSPOT®), Somatostatin Receptor scintigraphy (SRS) with \[111In\]-pentetreotide (Octreoscan® SPECT/CT), SRS with \[99mTc\]-Tektrotyd, \[64Cu\]-DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging. * The tumor uptake observed in the target lesions must be \> normal liver uptake. * Karnofsky Performance Score (KPS) ≥ 60 * Presence of at least 1 measurable site of disease * Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities Exclusion Criteria: * Creatinine clearance \< 40 mL/min calculated by the Cockroft Gault method * Hb concentration \< 5.0 mmol/L (\<8.0 g/dL); WBC \< 2x10E9/L (2000/mm3); platelets \< 75x10E9/L (75x10E3/mm3) * Total bilirubin \> 3 x ULN * Serum albumin \< 3.0 g/dL unless prothrombin time is within the normal range * Pregnancy or lactation * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study treatment period (including cross-over and re-treatment, if applicable) and for 7 months after study drug discontinuation * Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study. * Documented RECIST progression to previous treatments for the current GEP-NET at any time prior to randomization * Patients for whom in the opinion of the investigator other therapeutic options (eg chemo-, targeted therapy) are considered more appropriate than therapy offered in the study, based on patient and disease characteristics * Any previous therapy with Interferons, Everolimus (mTOR-inhibitors), chemotherapy or other systemic therapies for GEP-NET administered for more than 1 month or within 12 weeks prior to randomization in the study. * Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET * Any surgery within 12 weeks prior to randomization in the study * Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to screening in the study. Patients with a history of brain metastases must have a head CT or MRI with contrast to document stable disease prior to randomization in the study. * Uncontrolled congestive heart failure (NYHA II, III, IV). Patients with history of congestive heart failure who do not violate this exclusion criterion will undergo an evaluation of their cardiac ejection fraction prior to randomization via echocardiography. The results from an earlier assessment (not exceeding 30 days prior to randomization) may substitute the evaluation at the discretion of the Investigator, if no clinical worsening is noted. The patient's measured cardiac ejection fraction in these patients must be ≥40% before randomization. * QTcF \> 470 msec for females and QTcF \> 450 msec for males or congenital long QT syndrome * Uncontrolled diabetes mellitus as defined by hemoglobin A1c value \> 7.5% * Hyperkaleamia \> 6.0 mmol/L (CTCAE Grade 3) which is not corrected prior to study enrolment * Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of Lutathera, or any patient receiving treatment with SSAs (e.g. octreotide long-acting), which cannot be interrupted for at least 6 weeks before the administration of Lutathera. * Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study. * Prior external beam radiation therapy to more than 25% of the bone marrow. * Current spontaneous urinary incontinence * Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years * Patient with known incompatibility to CT Scans with IV contrast due to allergic reaction or renal insufficiency. If such a patient can be imaged with MRI, then the patient would not be excluded. * Hypersensitivity to any somatostatin analogues, the IMPs active substance or to any of the excipients. * Patients who have participated in any therapeutic clinical study/received any investigational agent within the last 30 days

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Gastro-enteropancreatic neuroendocrine tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Gastro-enteropancreatic neuroendocrine tumor

Contacts and locations

Locations

  • A.O.di Bologna Policl.S.Orsola

    Bologna, Italy

  • Arcispedale Santa Maria Nuova, Reggio Emilia - Oncology

    Reggio Emilia, Italy

  • Asan Medical Center - Oncology

    Seoul, South Korea

  • Azienda Ospedaliera Sant'Andrea - Università La Sapienza U.O.C. Mal App. Digerente e - Oncology

    Roma, Italy

  • BC Cancer Agency

    Vancouver, Canada

  • Bristol Haematology and Oncology Centre

    Bristol, United Kingdom

  • CHU Paris Nord-Val de Seine

    Clichy, France

  • CHU-Hôtel Dieu Service de Médecine Nucléaire

    Nantes, France

  • Centre Hospitalier Universitaire de Quebec

    Québec, Canada

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • Fondazione Irccs Istituto Nazionale Tumori

    Milan, Italy

  • Guys And St Thomas Hospital

    London, United Kingdom

  • Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot

    Lyon, France

  • Hospital General Universitario Gregorio Marañón

    Madrid, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Hospital Universitario Vall d'Hebrón

    Barcelona, Spain

  • IRCCS fondazione Pascale - Oncology

    Naples, Italy

  • Ieo, Irccs

    Milan, Italy

  • Institut Gustave Roussy

    Villejuif, France

  • Institut du Cancer de Montpellier - Oncology

    Montpellier, France

  • Istituto Oncologico Romagnolo

    Meldola, Italy

  • Kings College Hospital - Oncology

    London, United Kingdom

  • London Health Sciences Centre, University of Western Ontario - Oncology

    London, Canada

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic - Oncology

    Rochester, Minnesota, 55905, United States

  • Royal Free Hospital, London

    London, United Kingdom

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Seoul National University Hospital - Department of Internal Medicine

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System - Medical Oncology

    Seoul, South Korea

  • Sunnybrook Health Sciences Centre

    Toronto, Canada

  • UMC Utrecht - Oncology

    Utrecht, Netherlands

  • USF - H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • University of Genova - Oncology

    Genova, Italy

  • University of Iowa Hospitals and Clinics - Oncology

    Iowa City, Iowa, 52242, United States

  • University of Kentucky UK Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • Universitätsklinikum Erlangen

    Erlangen, Germany

  • Universitätsklinikum Essen - Klinik für Nuklearmedizin

    Essen, Germany

  • Weston Park Hospital

    Sheffield, United Kingdom

  • Yale Cancer Center

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.