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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanzalintinib — DRUG
  Administered as specified in the treatment arm.
• Everolimus — DRUG
  Administered as specified in the treatment arm.

Study Details

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.

Key Dates

Start date

Jul 21, 2025

Status verified

Apr 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

440 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Zanzalintinib
  Participants will receive zanzalintinib oral tablets once daily.
• Active Comparator: Everolimus
  Participants will receive everolimus oral tablets once daily.

Primary Outcome Measure

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

Central Contacts

• Exelixis Clinical Trials
  1-888-EXELIXIS (888-393-5494)
  [email protected]
• Backup or International
  650-837-7400

Locations (39)

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