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RecruitingLast updated: 26 March 2026

STELLAR-311: A trial is comparing effectiveness of two different targeted therapies for people with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Neuroendocrine tumours Neuroendocrine tumours

Age

People18+

Trial acronym

STELLAR-311

Clinical summary

Summary

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.

Eligible participants will be randomly allocated to one of two groups. 

  • Experimental arm - Participants will receive Zanzalintinib (also known as XL092) oral tablets once daily.
  • Active comparator arm - Participants will receive Everolimus (also known as Afinitor) oral tablets once daily.

Conditions

This trial is treating people with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors of pancreatic origin or extra-pancreatic origin.

Eligibility

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You are able to swallow medication by mouth.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Exelixis

Scientific Title

A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors

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