STELLAR 311

Actively Recruiting

Phase 2/3 Randomized, Open-Label Study of Zanzalintinib (XL092) vs Everolimus in Previously Treated Advanced or Metastatic Neuroendocrine Tumors

ZANZALINTINIB IS NOT APPROVED FOR THE USE UNDER INVESTIGATION IN THIS TRIAL. SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED.

Study Overview
Key Eligibility Criteria
Key Endpoints
Participating Sites

Study Overview

For the phase 2 stage of the trial, approximately 120 eligible patients with unresectable, locally advanced or metastatic NET will be randomized in a 1:1 ratio to either zanzalintinib or everolimus. If the phase 2 analysis supports trial continuation to phase 3, an additional 320 patients will be randomized for a total of approximately 440 patients in this trial. The primary objective of the trial is to evaluate PFS by BICR of zanzalintinib vs everolimus.

Chart explaining phase 3, randomized, open-label study of zanzalintinib with atezolizumab vs regorafenib in patients with MSS/MSI-low mCRC

Stratification Factors

Primary tumor site: pNET vs epNET
Prior PRRT: yes vs no
Tumor grade: Grade 1 or typical carcinoid vs Grades 2 or 3 or atypical carcinoid

Key Eligibility Criteria

Histologically confirmed, unresectable, locally advanced or metastatic, well-differentiated Grades 1, 2, or 3 pNET or epNET
Documented radiographic disease progression
Measurable disease
Functional or nonfunctional tumors
Somatostatin receptor positive or negative disease
Up to one prior line of systemic anticancer treatment
- Prior treatment with SSA not counted as a line of prior therapy
No prior treatment with a VEGFR-targeting TKI or an mTOR inhibitor

Key Endpoints

Primary Endpoint

PFS by BICR

Secondary Endpoints

OS
ORR, DOR, and DCR by BICR
PFS, ORR, DOR, and DCR by investigator
HRQoL and disease-related symptoms by EORTC QLQ-C30/QLQ-GI.NET21

Exploratory Endpoint

HRQoL by EQ-5D-5L

BICR, blinded independent central review; DCR, disease control rate; DOR, duration of response; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; EORTC QLQ-GI.NET21, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Gastrointestinal Neuroendocrine Tumours 21; epNET, extra-pancreatic neuroendocrine tumor; EQ-5D-5L, EuroQoL five-dimension, five-level health questionnaire instrument; HRQoL, health-related quality of life; mTOR, mammalian target of rapamycin; NET, neuroendocrine tumor; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; pNET, pancreatic neuroendocrine tumor; PRRT, peptide receptor radionuclide therapy; qd, once daily; SSA, somatostatin analogue; TKI, tyrosine kinase inhibitor; VEGFR, vascular endothelial growth factor receptor.

Participating Sites

STELLAR-311 will be conducted in North America, South America, Europe, and Asia Pacific. Call 1-888-393-5494 (toll-free) or 1-303-389-1847 for specific location and site information and to confirm whether sites near you are still enrolling new patients.

Currently open or planned clinical site cities:

Trial sites may stop enrolling patients at any time. Please check back if you do not see a trial site located near you.

To learn more about this trial, go to clinicaltrials.gov and search for NCT06943755, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free),
1-303-389-1847, or medinfo@exelixis.com.