RecruitingPhase 2Phase 3NCT06943755

Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors

Sponsor

Exelixis

Enrollment

440 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Neuroendocrine Tumor (pNET)Extra-Pancreatic Neuroendocrine Tumor (epNET)

Summary

The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing zanzalintinib (a new oral targeted drug) with everolimus (a standard drug) in patients with advanced neuroendocrine tumors (NETs) — slow-growing tumors that start in hormone-producing cells — that have progressed on prior treatment. **You may be eligible if...** - You have confirmed advanced or metastatic well-differentiated neuroendocrine tumors (Grade 1, 2, or 3) from the pancreas or other sites - Your cancer progressed on imaging within the past 12 months - You have measurable disease on scans - You have received prior lines of treatment appropriate for your tumor type **You may NOT be eligible if...** - You have neuroendocrine carcinoma (a more aggressive type, including small cell lung cancer) - You have medullary thyroid cancer, pheochromocytoma, Merkel cell carcinoma, or mixed neuroendocrine tumors - You have previously received a VEGFR-targeting drug or everolimus - You have active brain metastases or serious organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanzalintinib

Administered as specified in the treatment arm.

DRUGEverolimus

Administered as specified in the treatment arm.

Locations(126)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

Cedars-Sinai Medical Center

Beverly Hills, California, United States

Norris Comprehensive Cancer Center

Los Angeles, California, United States

Stanford Cancer Center

Palo Alto, California, United States

UCLA Health - Santa Monica Cancer Care

Santa Monica, California, United States

Kaiser Permanente Medical Center

Vallejo, California, United States

Georgetown University

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

Mayo Clinic - Florida

Jacksonville, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Cancer- Detroit

Detroit, Michigan, United States

The Cancer and Hematology Centers

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Siteman Cancer Center

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Icahan School of Medicine at Mount Sinai

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

Texas Oncology- Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Monash Health

Clayton, Australia

Royal Brisbane and Women's Hospital

Herston, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

GenesisCare North Shore

St Leonards, Australia

The Queen Elizabeth Hospital

Woodville South, Australia

Medical University of Graz

Graz, Austria

Paracelsus Medical University Hospital Salzburg

Salzburg, Austria

Medical University of Vienna

Vienna, Austria

Institut Jules Bordet

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Cliniques Universitaires Saint-Luc (UCLouvain)

Woluwe-Saint-Lambert, Belgium

Associação Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Verspeeten Family Cancer Center - London Health Sciences Centre

London, Canada

The Ottawa Hospital Cancer Center

Ottawa, Canada

Sunnybrook Health Sciences Centre

Toronto, Canada

Humanity and Health Clinical Trial Centre

Hong Kong, China

Prince of Wales Hospital

Hong Kong, China

Queen Mary Hospital

Hong Kong, China

Centre Hospitalier Universitaire de Caen Normandie

Caen, France

CHU Beaujon

Clichy, France

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

Lille, France

Hospices Civils de Lyon

Lyon, France

Hôpital Timone

Marseille, France

CHU de Montpellier Hôpital Saint Eloi

Montpellier, France

Centre Hospitalier Universitaire Nantes

Nantes, France

Centre Eugéne Marquis

Rennes, France

CHRU Strasbourg Hôpital Hautepierre

Strasbourg, France

Centre Hospitalier Universitaire (CHU) Toulouse

Toulouse, France

Gustave Roussy

Villejuif, France

Evangelische Lungenklinik

Berlin, Germany

Universitätsklinik Erlangen

Erlangen, Germany

ENETS Center of Excellence, University Hospital Essen

Essen, Germany

Universitätsmedizin Mainz der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg

Marburg, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

University Hospital Würzburg

Würzburg, Germany

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

Bologna, Italy

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

Meldola, Italy

Humanitas Mirasole S.p.A.

Milan, Italy

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

Instituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori IRCCS - Fondazione Pascale

Naples, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano to, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, Italy

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, Italy

Het Netherlands Kanker Institut (NKI)/ Antoni van Leeuwenhoek

Amsterdam, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands

Maxima Medisch Centrum

Veldhoven, Netherlands

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

Gliwice, Poland

Śląskiego Uniwersytet Medyczny w Katowicach

Katowice, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie

Krakow, Poland

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

Warsaw, Poland

FutureMeds Wrocław

Wroclaw, Poland

Pan American Center for Oncology Trials, LLC

San Juan, Puerto Rico

FDI Clinical Research

San Juan, Puerto Rico

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severence Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Vall D'Hebron

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital General Universitario J.M Morales Meseguer

Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitario Vigen Del Rocío

Seville, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Taipei Veterans General Hospital

Taipei, Taiwan

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Velindre Cancer Center

Cardiff, United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

The Clatterbridge Cancer Centre

Liverpool, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Swansea Bay University Health Board

Swansea, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06943755