Phase 23 Study Comparing Zanzalintinib and Everolimus in Adults with Advanced or Metastatic Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the effectiveness of two drugs, zanzalintinib and everolimus, in participants with previously treated, unresectable, locally advanced, or metastatic neuroendocrine tumors. This study includes participants with pancreatic or extra-pancreatic neuroendocrine tumors that have shown disease progression after prior treatments. The trial is a Phase 23, randomized, open-label study aiming to compare these treatments to better understand their impact on this condition. Participants will be randomly assigned to receive either everolimus or zanzalintinib as oral tablets taken once daily. The study follows a sequential model where participants receive one of the two study drugs, and treatment continues as per protocol. There is no placebo group, and the study is designed to monitor and compare the treatments over an extended period. During the study, participants will be regularly assessed through imaging tests like CT or MRI scans to measure tumor progression using RECIST 1.1 criteria. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and disease control rates up to 48-60 months. Participant-reported quality of life and symptoms will also be evaluated using specific questionnaires. Safety will be monitored by tracking adverse events throughout the study duration.

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