RecruitingRecruiting
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
NCT06943755 · Exelixis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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 criteria
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.
Study design
Enrollment target: 440 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-21
Estimated completion: 2029-06-30
Last updated: 2026-07-09
Interventions
Drug: ZanzalintinibDrug: Everolimus
Primary outcomes
- • Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) (Up to 48 months)
Sponsor
Exelixis · industry
Contacts & investigators
ContactExelixis Clinical Trials · contact · druginfo@exelixis.com · 1-888-EXELIXIS (888-393-5494)
ContactBackup or International · contact · 650-837-7400
InvestigatorMedical Director · study_director, Exelixis
All locations (97)
The University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Mayo Clinic HospitalRecruiting
Phoenix, Arizona, United States
The University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
Cedars-Sinai Medical CenterRecruiting
Beverly Hills, California, United States
Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Stanford Cancer CenterRecruiting
Palo Alto, California, United States
UCLA Health - Santa Monica Cancer CareRecruiting
Santa Monica, California, United States
Kaiser Permanente Medical CenterRecruiting
Vallejo, California, United States
Georgetown UniversityRecruiting
Washington D.C., District of Columbia, United States
Mayo Clinic - FloridaRecruiting
Jacksonville, Florida, United States
AdventHealth OrlandoRecruiting
Orlando, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
University of Kentucky Markey Cancer CenterRecruiting
Lexington, Kentucky, United States
East Jefferson General HospitalRecruiting
Metairie, Louisiana, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford Caner- DetroitRecruiting
Detroit, Michigan, United States
The Cancer and Hematology CentersRecruiting
Grand Rapids, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
University of New Mexico Comprehensive Cancer CenterRecruiting
Albuquerque, New Mexico, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Icahan School of Medicine at Mount SinaiRecruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Sanford Roger Maris Cancer CenterRecruiting
Fargo, North Dakota, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
University of Tennessee Medical CenterRecruiting
Knoxville, Tennessee, United States
Henry-Joyce Cancer ClinicRecruiting
Nashville, Tennessee, United States
Texas Oncology- Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
Huntsman Cancer Institute, University of UtahRecruiting
Salt Lake City, Utah, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Virginia Cancer Specialists - Fairfax OfficeRecruiting
Fairfax, Virginia, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Froedtert Hospital and the Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Monash HealthRecruiting
Clayton, Australia
Royal Brisbane and Women's HospitalRecruiting
Herston, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Australia
GenesisCare North ShoreRecruiting
St Leonards, Australia
The Queen Elizabeth HospitalRecruiting
Woodville South, Australia
Medical University of GrazRecruiting
Graz, Austria
Paracelsus Medical University Hospital SalzburgRecruiting
Salzburg, Austria
Cliniques Universitaires Saint-Luc (UCLouvain)Recruiting
Woluwe-Saint-Lambert, Belgium
Verspeeten Family Cancer Center - London Health Sciences CentreRecruiting
London, Canada
The Ottawa Hospital Cancer CenterRecruiting
Ottawa, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Canada
Humanity and Health Clinical Trial CentreRecruiting
Hong Kong, China
Prince of Wales HospitalRecruiting
Hong Kong, China
Queen Mary HospitalRecruiting
Hong Kong, China
CHU de Montpellier Hôpital Saint EloiRecruiting
Montpellier, France
Gustave RoussyRecruiting
Villejuif, France
Evangelische LungenklinikRecruiting
Berlin, Germany
Universitätsklinikum Gießen und Marburg GmbH, Standort MarburgRecruiting
Marburg, Germany
Universitätsklinikum TübingenRecruiting
Tübingen, Germany
University Hospital WürzburgRecruiting
Würzburg, Germany
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST s.r.l.Recruiting
Meldola, Italy
Instituto Europeo di OncologiaRecruiting
Milan, Italy
Istituto Nazionale Tumori IRCCS - Fondazione PascaleRecruiting
Naples, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo GiacconeRecruiting
Palermo, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto IRecruiting
Roma, Italy
Het Netherlands Kanker Institut (NKI)/ Antoni van LeeuwenhoekRecruiting
Amsterdam, Netherlands
Maastricht Universitair Medisch CentrumRecruiting
Maastricht, Netherlands
Maxima Medisch CentrumRecruiting
Veldhoven, Netherlands
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Oddział w GliwicachRecruiting
Gliwice, Poland
Śląskiego Uniwersytet Medyczny w KatowicachRecruiting
Katowice, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwesytecki w KrakowieRecruiting
Krakow, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut BadawczyRecruiting
Warsaw, Poland
FutureMeds WrocławRecruiting
Wroclaw, Poland
Pan American Center for Oncology Trials, LLCRecruiting
San Juan, Puerto Rico
FDI Clinical ResesarchWithdrawn
San Juan, Puerto Rico
Korea University Anam HospitalRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severence Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hospital Universitario Vall D'HebronRecruiting
Barcelona, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital General Universitario J.M Morales MeseguerRecruiting
Murcia, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Spain
Hospital Universitario Marqués de ValdecillaRecruiting
Santander, Spain
Hospital Clínico Universitario de Santiago de CompostelaRecruiting
Santiago de Compostela, Spain
Hospital Universitario Vigen Del RocíoRecruiting
Seville, Spain
Hospital Universitario y Politécnico La FeRecruiting
Valencia, Spain
Hospital Universitario Miguel ServetRecruiting
Zaragoza, Spain
The Clatterbridge Cancer CentreRecruiting
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation TrustRecruiting
London, United Kingdom
King's College Hospital NHS Foundation TrustRecruiting
London, United Kingdom
Oxford University Hospitals NHS Foundation TrustRecruiting
Oxford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
Sheffield, United Kingdom
Swansea Bay University Health BoardRecruiting
Swansea, United Kingdom