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

Launched by EXELIXIS · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments, zanzalintinib and everolimus, for patients with advanced neuroendocrine tumors (NETs) that cannot be surgically removed. These tumors can originate in the pancreas (pancreatic neuroendocrine tumors, or pNET) or in other areas of the body (extra-pancreatic neuroendocrine tumors, or epNET). The goal is to see which treatment is more effective for patients who have already received other treatments and have tumors that are still growing.

To be eligible for the trial, participants should have confirmed advanced NETs that are well-differentiated and can be measured through imaging tests like CT or MRI. They must have had previous treatments and experienced disease progression within the last year. Patients with certain types of neuroendocrine cancers, or those who have recently received specific therapies, may not qualify. This trial is still in the planning stages and has not started recruiting participants yet. If you or a loved one is interested in participating, it’s important to discuss this study with your healthcare provider to understand more about what to expect and whether it’s a good option.

Gender

ALL

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.