Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06943755.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Approved
Name Not AvailableCalifornia
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Jenna Lee Davis
Phone: 310-633-8400
Email: JLDavis@mednet.ucla.edu
Los Angeles General Medical Center
Status: Active
Contact: Charlean Ketchens
Phone: 323-865-3035
Email: ketchens_c@med.usc.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Charlean Ketchens
Phone: 323-865-3035
Email: ketchens_c@med.usc.edu
Newport Beach
USC Norris Oncology/Hematology-Newport Beach
Status: Active
Contact: Charlean Ketchens
Phone: 323-865-3035
Email: ketchens_c@med.usc.edu
Florida
Jacksonville
Mayo Clinic in Florida
Status: Approved
Name Not AvailableTampa
Moffitt Cancer Center
Status: Active
Name Not AvailableKentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableMinnesota
Rochester
Mayo Clinic in Rochester
Status: Approved
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNew Mexico
Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not AvailableNew York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not AvailableNorth Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not AvailableDurham
Duke University Medical Center
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailablePennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableUtah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not AvailableVirginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not AvailableTrial PhasePhase II/III
Trial Typetreatment
Lead OrganizationExelixis Inc
- Primary IDXL092-311
- Secondary IDsNCI-2025-04266, 2025-521043-20-00
- ClinicalTrials.gov IDNCT06943755