Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• The University of Alabama at Birmingham, Birmingham, Alabama, United States
• Mayo Clinic Hospital, Phoenix, Arizona, United States
• The University of Arizona Cancer Center, Tucson, Arizona, United States
• Cedars-Sinai Medical Center, Beverly Hills, California, United States
• Norris Comprehensive Cancer Center, Los Angeles, California, United States
• Stanford Cancer Center, Palo Alto, California, United States
• UCLA Health - Santa Monica Cancer Care, Santa Monica, California, United States
• Kaiser Permanente Medical Center, Vallejo, California, United States
• Georgetown University, Washington D.C., District of Columbia, United States
• Mayo Clinic - Florida, Jacksonville, Florida, United States
• AdventHealth Orlando, Orlando, Florida, United States
• Moffitt Cancer Center, Tampa, Florida, United States

+ 85 more sites.

Who to contact

Exelixis Clinical Trials · 1-888-EXELIXIS (888-393-5494) · druginfo@exelixis.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06943755.