Zanzalintinib versus everolimus for advanced or metastatic pancreatic and extra‑pancreatic neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with well‑differentiated Grade 1–3 pancreatic or extra‑pancreatic neuroendocrine tumors that have progressed after prior therapy will be enrolled. Participants must have measurable disease by RECIST 1.1 and documented radiographic progression within 12 months, and tumor tissue (archival or fresh biopsy) is required when feasible. Enrolled participants will receive either zanzalintinib or everolimus and will be followed with imaging and clinical assessments to compare outcomes between the two treatments. The trial spans phase 2/3 to determine whether the newer agent provides improved disease control compared with the established mTOR inhibitor.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

+85 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Exelixis Clinical Trials
• Email: druginfo@exelixis.com
• Phone: 1-888-EXELIXIS (888-393-5494)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.