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Zanzalintinib Versus Everolimus for Neuroendocrine Tumors

This study is comparing two medicines, zanzalintinib and everolimus, to see which is more effective for people with advanced neuroendocrine tumors that started in the pancreas (pNET) or elsewhere (epNET). These tumors are well-differentiated and have progressed after previous treatments. Zanzalintinib works by blocking certain signals in cancer cells (ERK, KINASE INHIBITOR, MTOR, TYROSINE KINASE, VEGF, VEGFR). You may be able to join if you are 18 or older, have a confirmed diagnosis of these types of neuroendocrine tumors, and your disease has worsened. The main goal is to see how long people live without their cancer growing (Progression-Free Survival) for up to 48 months. The current status of this study is unclear.

Study design
This study is comparing two different drugs. It plans to enroll 440 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome will be measured for up to 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06943755

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Exelixis
~440 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:ZanzalintinibEverolimus

At a glance

Recruiting sites
125 of 126 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Measured over Up to 48 months

Conditions

Pancreatic Neuroendocrine Tumor (pNET)
Extra-Pancreatic Neuroendocrine Tumor (epNET)

Explore related trials

Digestive System Neuroendocrine TumorNeuroendocrine TumorPancreatic Neuroendocrine Tumor

NCT06943755

Where you'd take part

This study runs at 126 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Orlando

    Orlando, Floridano site contact published

    Recruiting

  • Amsterdam UMC

    Amsterdam, Netherlandsno site contact published

    Recruiting

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Recruiting

  • Associação Hospitalar Moinhos de Vento

    Porto Alegre, Brazilno site contact published

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Italyno site contact published

    Recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

    Bologna, Italyno site contact published

    Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Roma, Italyno site contact published

    Recruiting

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano to, Italyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Exelixis

Who to contact

Exelixis Clinical Trials
[email protected]
1-888-EXELIXIS (888-393-5494)
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)Up to 48 months