STELLAR-311: a randomized phase II/III study of zanzalintinib versus everolimus in advanced neuroendocrine tumors
7 affiliations
- 1Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA
- 2Medical Oncology, Moffitt Cancer Center, Tampa, FL, USA
- 3Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
- 4Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada
- 5Statistics, Exelixis, Inc., Alameda, CA, USA
- 6Clinical Development, Exelixis, Inc ., Alameda, CA, USA
- 7Medical Oncology Department, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Abstract
Patients with advanced neuroendocrine tumors (NETs) experience poor outcomes despite the use of available therapies, including molecularly targeted agents. Zanzalintinib is a novel, small-molecule inhibitor of multiple kinases, including the TAM kinases (TYRO3, AXL, MER), MET, and vascular endothelial growth factor receptors, which play important roles in oncogenic processes. Zanzalintinib has shown encouraging antitumor activity and a consistent safety profile across multiple solid tumor types in clinical trials. STELLAR-311 is a global, randomized, open-label, phase II/III trial evaluating the efficacy and safety of zanzalintinib versus everolimus in patients with advanced NETs. Adults aged ≥18 years with locally advanced/unresectable or metastatic, well-differentiated grade 1–3 NETs of pancreatic (pNET) or extra-pancreatic (epNET; gastrointestinal tract, lung, thymus, or other) origin will be enrolled. Patients with pNETs or nonfunctional epNETs can be untreated or have received up to one prior line of therapy (excluding somatostatin analogs); patients with functional epNETs must have received one prior line of therapy. The primary endpoint is progression-free survival (PFS), by blinded independent central review (BICR). Secondary endpoints include overall survival; investigator-assessed PFS; BICR- and investigator-assessed objective response rate, duration of response, and disease control rate; safety; and quality of life.
Clinical trial registration www.clinicaltrials.gov identifier is NCT06943755.
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BibTeX
@article{chan2026stellar311,
title = {{STELLAR-311: a randomized phase II/III study of zanzalintinib versus everolimus in advanced neuroendocrine tumors}},
author = {Jennifer A. Chan and Jonathan R. Strosberg and Changhoon Yoo and Simron Singh and Huang Huang and Manika Goel and Christian Scheffold and Jaume Capdevila},
journal = {Future Oncology},
year = {2026},
month = sep,
doi = {10.1080/14796694.2026.2733790},
url = {https://doi.org/10.1080/14796694.2026.2733790},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - STELLAR-311: a randomized phase II/III study of zanzalintinib versus everolimus in advanced neuroendocrine tumors
AU - Jennifer A. Chan
AU - Jonathan R. Strosberg
AU - Changhoon Yoo
AU - Simron Singh
AU - Huang Huang
AU - Manika Goel
AU - Christian Scheffold
AU - Jaume Capdevila
PY - 2026
DA - 2026/09/28
JO - Future Oncology
DO - 10.1080/14796694.2026.2733790
UR - https://doi.org/10.1080/14796694.2026.2733790
AB - Patients with advanced neuroendocrine tumors (NETs) experience poor outcomes despite the use of available therapies, including molecularly targeted agents. Zanzalintinib is a novel, small-molecule inhibitor of multiple kinases, including the TAM kinases (TYRO3, AXL, MER), MET, and vascular endothelial growth factor receptors, which play important roles in oncogenic processes. Zanzalintinib has shown encouraging antitumor activity and a consistent safety profile across multiple solid tumor types in clinical trials. STELLAR-311 is a global, randomized, open-label, phase II/III trial evaluating the efficacy and safety of zanzalintinib versus everolimus in patients with advanced NETs. Adults aged ≥18 years with locally advanced/unresectable or metastatic, well-differentiated grade 1–3 NETs of pancreatic (pNET) or extra-pancreatic (epNET; gastrointestinal tract, lung, thymus, or other) origin will be enrolled. Patients with pNETs or nonfunctional epNETs can be untreated or have received up to one prior line of therapy (excluding somatostatin analogs); patients with functional epNETs must have received one prior line of therapy. The primary endpoint is progression-free survival (PFS), by blinded independent central review (BICR). Secondary endpoints include overall survival; investigator-assessed PFS; BICR- and investigator-assessed objective response rate, duration of response, and disease control rate; safety; and quality of life. Clinical trial registration www.clinicaltrials.gov identifier is NCT06943755.
SN - 1479-6694
SN - 1744-8301
ER -