What is the Purpose of this Study?
Primary Objective: To evaluate progression-free survival (PFS) by blinded independent central review (BICR) of zanzalintinib versus everolimus Secondary Objectives: To evaluate objective response rate (ORR) by BICR of zanzalintinib versus everolimus To evaluate overall survival (OS) of zanzalintinib versus everolimus To evaluate duration of response (DOR) by BICR of zanzalintinib versus everolimus To evaluate PFS, ORR, and DOR by Investigator review of zanzalintinib versus everolimus To evaluate disease control rate (DCR) of zanzalintinib versus everolimus as assessed by BICR and by Investigator To evaluate health-related quality of life (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
Eligibility
- * 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.
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi
More about this Clinical Trial
What is the full name of this clinical trial?
XL092-311: 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