NCT06943755From ClinicalTrials.govRecruiting

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

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

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Exelixis
Enrolment target: 440
Started: 21 July 2025
Main results due: 30 June 2029
Study sites: 131
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(131)

The University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, United States
Recruiting
The University of Arizona Cancer Center
Tucson, Arizona, United States
Recruiting
Cedars-Sinai Medical Center
Beverly Hills, California, United States
Recruiting
Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
Stanford Cancer Center
Palo Alto, California, United States
Recruiting
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, United States
Recruiting
Kaiser Permanente Medical Center
Vallejo, California, United States
Recruiting
Georgetown University
Washington D.C., District of Columbia, United States
Recruiting
Mayo Clinic - Florida
Jacksonville, Florida, United States
Recruiting
AdventHealth Orlando
Orlando, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Recruiting
East Jefferson General Hospital
Metairie, Louisiana, United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Henry Ford Cancer- Detroit
Detroit, Michigan, United States
Recruiting
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Recruiting
Siteman Cancer Center
St Louis, Missouri, United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Recruiting
Icahan School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruiting
Oregon Health and Science University
Portland, Oregon, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Recruiting
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Recruiting
University of Virginia
Charlottesville, Virginia, United States
Recruiting
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, United States
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Recruiting
Monash Health
Clayton, Australia
Recruiting
Royal Brisbane and Women's Hospital
Herston, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Australia
Recruiting
Fiona Stanley Hospital
Murdoch, Australia
Recruiting
GenesisCare North Shore
St Leonards, Australia
Recruiting
The Queen Elizabeth Hospital
Woodville South, Australia
Recruiting
Medical University of Graz
Graz, Austria
Recruiting
Paracelsus Medical University Hospital Salzburg
Salzburg, Austria
Recruiting
Medical University of Vienna
Vienna, Austria
Recruiting
Institut Jules Bordet
Brussels, Belgium
Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
Recruiting
UZ Leuven
Leuven, Belgium
Recruiting
Cliniques Universitaires Saint-Luc (UCLouvain)
Woluwe-Saint-Lambert, Belgium
Recruiting
Associação Hospitalar Moinhos de Vento
Porto Alegre, Brazil
Recruiting
Verspeeten Family Cancer Center - London Health Sciences Centre
London, Canada
Recruiting
The Ottawa Hospital Cancer Center
Ottawa, Canada
Recruiting
Sunnybrook Health Sciences Centre
Toronto, Canada
Recruiting
Humanity and Health Clinical Trial Centre
Hong Kong, China
Recruiting
Prince of Wales Hospital
Hong Kong, China
Recruiting
Queen Mary Hospital
Hong Kong, China
Recruiting

Showing 60 of 131 sites — filter to narrow it down. 130 of the 131 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06943755. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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