Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
NCT ID: NCT06943755
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
440 participants
INTERVENTIONAL
2025-07-21
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Zanzalintinib
Participants will receive zanzalintinib oral tablets once daily.
Zanzalintinib
Administered as specified in the treatment arm.
Everolimus
Participants will receive everolimus oral tablets once daily.
Everolimus
Administered as specified in the treatment arm.
Interventions
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Zanzalintinib
Administered as specified in the treatment arm.
Everolimus
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Exelixis
Locations
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Exelixis Clinical Site #18
Beverly Hills, California, United States
Exelixis Clinical Site #16
Los Angeles, California, United States
Exelixis Clinical Site #12
Santa Monica, California, United States
Exelixis Clinical Site #19
Washington D.C., District of Columbia, United States
Exelixis Clinical Site #11
Tampa, Florida, United States
Exelixis Clinical Site #9
Lexington, Kentucky, United States
Exelixis Clinical Site #8
Boston, Massachusetts, United States
Exelixis Clinical Site #1
Grand Rapids, Michigan, United States
Exelixis Clinical Site #5
St Louis, Missouri, United States
Exelixis Clinical Site #14
Albuquerque, New Mexico, United States
Exelixis Clinical Site #7
New York, New York, United States
Exelixis Clinical Site #17
Chapel Hill, North Carolina, United States
Exelixis Clinical Site #6
Durham, North Carolina, United States
Exelixis Clinical Site #20
Philadelphia, Pennsylvania, United States
Exelixis Clinical Site #10
Grapevine, Texas, United States
Exelixis Clinical Site #15
Salt Lake City, Utah, United States
Exelixis Clinical Site #3
Charlottesville, Virginia, United States
Exelixis Clinical Site #13
Fairfax, Virginia, United States
Exelixis Clinical Site #2
San Juan, , Puerto Rico
Exelixis Clinical Site # 4
San Juan, , Puerto Rico
Countries
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Central Contacts
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Backup or International
Role: CONTACT
Other Identifiers
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2025-521043-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
XL092-311
Identifier Type: -
Identifier Source: org_study_id