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Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
NCT06943755 · Exelixis
In plain English
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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
Last updated: 2026-04-17
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 (80)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Vallejo, California, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Lexington, Kentucky, United States
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Metairie, Louisiana, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Fargo, North Dakota, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Saint Leonards, New South Wales, Australia
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Woodville South, South Australia, Australia
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Clayton, Victoria, Australia
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Clayton, Victoria, Australia
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Herston, Australia
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Graz, Austria
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Ottawa, Canada
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Toronto, Canada
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Hong Kong, China
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Berlin, Germany
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Tübingen, Germany
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Würzburg, Germany
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China, Hong Kong
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Naples, Naples, Italy
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Roma, Italy
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Warsaw, Masovian Voivodeship, Poland
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Katowice, Poland
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Warsaw, Poland
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Gliwice, Ślaskie, Poland
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San Juan, Puerto Rico
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San Juan, Puerto Rico
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Santiago de Compostela, A Coruña, Spain
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Oviedo, Principality of Asturias, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Murcia, Spain
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Santander, Spain
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Seville, Spain
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Valencia, Spain
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Zaragoza, Spain
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London, England, United Kingdom
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Oxford, England, United Kingdom
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Liverpool, United Kingdom
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Sheffield, United Kingdom