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New hope for neuroendocrine tumors: zanzalintinib takes on everolimus

NCT ID NCT06943755

Disease control Sponsor: Exelixis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 9 times

Summary

This study compares a new drug, zanzalintinib, to the current standard drug everolimus in people with advanced neuroendocrine tumors that have already been treated. The goal is to see which drug better slows tumor growth. About 440 participants will be randomly assigned to one of the two treatments.

What this could mean

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

Active substance
zanzalintinib
What this could lead to
If it works, this could offer a new treatment option for people with advanced neuroendocrine tumors that have stopped responding to other therapies.
What could go wrong
This is an early-to-mid-stage trial, so results are not guaranteed. The new drug may not be more effective than the existing drug everolimus, and side effects are possible.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 440 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2029

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.

Key Inclusion Criteria: * Histologically confirmed, locally advanced/unresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin. * Allowed prior lines of therapy, based on the site of NET and functional status. * Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) within 12 months before randomization. * Measurable disease according to RECIST 1.1 as determined by the Investigator. * Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue. Key Exclusion Criteria: * Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN). * Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor. * Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization. * Systemic radionuclide therapy within 6 weeks before randomization. * Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Adenoma, Islet Cell Neoplasm Metastasis neuroendocrine neoplasm pancreatic neuroendocrine tumor

As listed by the trial registrant

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

Extra-pancreatic neuroendocrine tumor (epnet) Pancreatic neuroendocrine tumor (PNET)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    125 sites in 17 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32804, United States

  • Amsterdam UMC

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Asan Medical Center

    RECRUITING

    Seoul, 5505, South Korea

  • Associação Hospitalar Moinhos de Vento

    RECRUITING

    Porto Alegre, 90560-032, Brazil

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    RECRUITING

    Palermo, 90127, Italy

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    RECRUITING

    Roma, 00161, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    RECRUITING

    Orbassano to, 10043, Italy

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    RECRUITING

    Roma, 00189, Italy

  • CHRU Strasbourg Hôpital Hautepierre

    RECRUITING

    Strasbourg, 67200, France

  • CHU Beaujon

    RECRUITING

    Clichy, 92110, France

  • CHU de Montpellier Hôpital Saint Eloi

    RECRUITING

    Montpellier, 34295, France

  • Cedars-Sinai Medical Center

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Centre Eugéne Marquis

    RECRUITING

    Rennes, 35042, France

  • Centre Hospitalier Universitaire (CHU) Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Claude Huriez

    RECRUITING

    Lille, 59037, France

  • Centre Hospitalier Universitaire Nantes

    RECRUITING

    Nantes, 44093, France

  • Centre Hospitalier Universitaire de Caen Normandie

    RECRUITING

    Caen, 14033, France

  • Cliniques Universitaires Saint-Luc (UCLouvain)

    RECRUITING

    Woluwe-Saint-Lambert, 1200, Belgium

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • ENETS Center of Excellence, University Hospital Essen

    RECRUITING

    Essen, 45157, Germany

  • East Jefferson General Hospital

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Evangelische Lungenklinik

    RECRUITING

    Berlin, 13125, Germany

  • FDI Clinical Research

    WITHDRAWN

    San Juan, 00927, Puerto Rico

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Froedtert Hospital and the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • FutureMeds Wrocław

    RECRUITING

    Wroclaw, 53-673, Poland

  • GenesisCare North Shore

    RECRUITING

    St Leonards, 2065, Australia

  • Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Guy's and St Thomas' NHS Foundation Trust

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Henry Ford Cancer- Detroit

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Henry-Joyce Cancer Clinic

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Het Netherlands Kanker Institut (NKI)/ Antoni van Leeuwenhoek

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Hospices Civils de Lyon

    RECRUITING

    Lyon, 69003, France

  • Hospital Clínico Universitario de Santiago de Compostela

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

  • Hospital General Universitario J.M Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, 33011, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Vall D'Hebron

    RECRUITING

    Barcelona, 8029, Spain

  • Hospital Universitario Vigen Del Rocío

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Humanitas Mirasole S.p.A.

    RECRUITING

    Milan, 20089, Italy

  • Humanity and Health Clinical Trial Centre

    RECRUITING

    Hong Kong, China

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Hôpital Timone

    RECRUITING

    Marseille, 13005, France

  • Icahan School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Institut Jules Bordet

    RECRUITING

    Brussels, 1070, Belgium

  • Instituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS - Fondazione Pascale

    RECRUITING

    Naples, 80131, Italy

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST s.r.l.

    RECRUITING

    Meldola, 47014, Italy

  • Kaiser Permanente Medical Center

    RECRUITING

    Vallejo, California, 94589, United States

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 2841, South Korea

  • Maastricht Universitair Medisch Centrum

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Maxima Medisch Centrum

    RECRUITING

    Veldhoven, 5504 DB, Netherlands

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic - Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Medical University of Graz

    RECRUITING

    Graz, 8036, Austria

  • Medical University of Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Monash Health

    RECRUITING

    Clayton, 3168, Australia

  • NHS Greater Glasgow and Clyde

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    RECRUITING

    Warsaw, 02-034, Poland

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Oddział w Gliwicach

    RECRUITING

    Gliwice, 44-102, Poland

  • Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97210, United States

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Pan American Center for Oncology Trials, LLC

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Paracelsus Medical University Hospital Salzburg

    RECRUITING

    Salzburg, 5020, Austria

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, 3000, Australia

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, China

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, China

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, 4029, Australia

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie

    RECRUITING

    Krakow, 30-688, Poland

  • Samsung Medical Center

    RECRUITING

    Seoul, 6351, South Korea

  • Sanford Roger Maris Cancer Center

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 3080, South Korea

  • Severence Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 3722, South Korea

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, S10 2SJ, United Kingdom

  • Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Stanford Cancer Center

    RECRUITING

    Palo Alto, California, 94305, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, M4N 3M5, Canada

  • Swansea Bay University Health Board

    RECRUITING

    Swansea, SA2 8QA, United Kingdom

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75264, United States

  • The Cancer and Hematology Centers

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • The Clatterbridge Cancer Centre

    RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43221, United States

  • The Ottawa Hospital Cancer Center

    RECRUITING

    Ottawa, K1H 8L6, Canada

  • The Queen Elizabeth Hospital

    RECRUITING

    Woodville South, 5011, Australia

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • The University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • The University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • UCLA Health - Santa Monica Cancer Care

    RECRUITING

    Santa Monica, California, 90404, United States

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospital Würzburg

    RECRUITING

    Würzburg, 97080, Germany

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Kentucky Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Comprehensive Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Tennessee Medical Center

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Universitätsklinik Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg

    RECRUITING

    Marburg, 35043, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsmedizin Mainz der Johannes Gutenberg-Universität Mainz

    RECRUITING

    Mainz, 44131, Germany

  • Velindre Cancer Center

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Verspeeten Family Cancer Center - London Health Sciences Centre

    RECRUITING

    London, N6A 5W9, Canada

  • Virginia Cancer Specialists - Fairfax Office

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Śląskiego Uniwersytet Medyczny w Katowicach

    RECRUITING

    Katowice, 40-514, Poland