Clinical Trial 23713

• Overview

  Study 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

  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.

  Objective:

  Primary Objective - To evaluate PFS by BICR of zanzalintinib versus everolimus Secondary: - To evaluate ORR by BICR of zanzalintinib versus everolimus - To evaluate OS of zanzalintinib versus everolimus - To evaluate DOR by BICR of zanzalintinib versus everolimus - To evaluate PFS, ORR, and DOR by Investigator review of zanzalintinib versus everolimus - To evaluate DCR of zanzalintinib versus everolimus as assessed by BICR and by Investigator - To evaluate HRQoL, disease-related symptoms, and other domains of zanzalintinib versus everolimus as assessed by EORTC QLQ-C30 and EORTC QLQ-GI.NET21 questionnaire instruments in participants with epNET and pNET - To evaluate safety and tolerability of zanzalintinib compared to everolimus

• Treatments

  Therapies:

  Tyrosine Kinase Inhibitor; mTOR inhibitor

  Medications:

  Zanubrutinib (); Zanzalintinib (); everolimus (RAD001)

• Inclusion 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.

• Exclusion Criteria

  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.
  • Other protocol defined Inclusion/Exclusion criteria may apply.

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