UPCC 13225: 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 (STELLAR-311)

Study of Investigational Medication vs Everolimus for Advanced Neuroendocrine Tumors

Enrolling By Invitation
18 years or above
All
Phase 2/3
440 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
  • Age: 18 years or above
  • Gender: All

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.

This study investigates neuroendocrine tumors. It focuses on participants who have previously received treatment for tumors that cannot be removed by surgery or have spread to other parts of the body.

This study evaluates the effectiveness of an investigational medication compared to everolimus. It examines how well the treatments work and their safety for participants.

  • Who can participate: Adults with advanced neuroendocrine tumors that have progressed despite prior treatment may join. Participants need measurable disease and must provide tumor samples if available.
  • Study details: Participants will receive either the investigational medication or everolimus. The study includes monitoring of treatment effects.
Updated on 22 Jul 2026. Study ID: 25-1604
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator