Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
STELLAR-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
3 other identifiers
interventional
440
14 countries
114
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
Typical duration for phase_2
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
July 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
August 7, 2026
July 1, 2026
3.9 years
April 17, 2025
August 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Up to 48 months
Secondary Outcomes (8)
PFS Per RECIST 1.1 as Assessed by Investigator
Up to 48 months
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator
Up to 48 months
Overall Survival (OS)
Up to 60 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator
Up to 48 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator
Up to 48 months
- +3 more secondary outcomes
Study Arms (2)
Everolimus
ACTIVE COMPARATORParticipants will receive everolimus oral tablets once daily.
Zanzalintinib
EXPERIMENTALParticipants will receive zanzalintinib oral tablets once daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue.
You may not qualify if:
- Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).
- Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.
- Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.
- Systemic radionuclide therapy within 6 weeks before randomization.
- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exelixislead
Study Sites (120)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Cedars-Sinai Medical Center
Beverly Hills, California, 90211, United States
Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Stanford Cancer Center
Palo Alto, California, 94305, United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, 90404, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
AdventHealth Orlando
Orlando, Florida, 32804, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Cancer- Detroit
Detroit, Michigan, 48202, United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49546, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Siteman Cancer Center
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Icahan School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43221, United States
Oregon Health and Science University
Portland, Oregon, 97210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75264, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Monash Health
Clayton, 3168, Australia
Royal Brisbane and Women's Hospital
Herston, 4029, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
GenesisCare North Shore
St Leonards, 2065, Australia
The Queen Elizabeth Hospital
Woodville South, 5011, Australia
Medical University of Graz
Graz, 8036, Austria
Paracelsus Medical University Hospital Salzburg
Salzburg, 5020, Austria
Medical University of Vienna
Vienna, 1090, Austria
Institut Jules Bordet
Brussels, 1070, Belgium
UZ Leuven
Leuven, 3000, Belgium
Cliniques Universitaires Saint-Luc (UCLouvain)
Woluwe-Saint-Lambert, 1200, Belgium
Verspeeten Family Cancer Center - London Health Sciences Centre
London, N6A 5W9, Canada
The Ottawa Hospital Cancer Center
Ottawa, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, M4N 3M5, Canada
Humanity and Health Clinical Trial Centre
Hong Kong, China
Prince of Wales Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Centre Hospitalier Universitaire de Caen Normandie
Caen, 14033, France
CHU Beaujon
Clichy, 92110, France
Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Claude Huriez
Lille, 59037, France
Hospices Civils de Lyon
Lyon, 69003, France
Hôpital Timone
Marseille, 13005, France
CHU de Montpellier Hôpital Saint Eloi
Montpellier, 34295, France
Centre Hospitalier Universitaire Nantes
Nantes, 44093, France
Centre Eugéne Marquis
Rennes, 35042, France
CHRU Strasbourg Hôpital Hautepierre
Strasbourg, 67200, France
Centre Hospitalier Universitaire (CHU) Toulouse
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94800, France
Evangelische Lungenklinik
Berlin, 13125, Germany
Universitätsklinik Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg
Marburg, 35043, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
University Hospital Würzburg
Würzburg, 97080, Germany
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, 40138, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST s.r.l.
Meldola, 47014, Italy
Humanitas Mirasole S.p.A.
Milan, 20089, Italy
Instituto Europeo di Oncologia
Milan, 20141, Italy
Istituto Nazionale Tumori IRCCS - Fondazione Pascale
Naples, 80131, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano to, 10043, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, 00161, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, 00189, Italy
Het Netherlands Kanker Institut (NKI)/ Antoni van Leeuwenhoek
Amsterdam, 1066 CX, Netherlands
Amsterdam UMC
Amsterdam, 1081 HV, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX, Netherlands
Maxima Medisch Centrum
Veldhoven, 5504 DB, Netherlands
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Oddział w Gliwicach
Gliwice, 44-102, Poland
Śląskiego Uniwersytet Medyczny w Katowicach
Katowice, 40-514, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie
Krakow, 30-688, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, 02-034, Poland
FutureMeds Wrocław
Wroclaw, 53-673, Poland
Pan American Center for Oncology Trials, LLC
San Juan, 00909, Puerto Rico
FDI Clinical Resesarch
San Juan, 00927, Puerto Rico
Korea University Anam Hospital
Seoul, 2841, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Severence Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Hospital Universitario Vall D'Hebron
Barcelona, 8029, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital General Universitario J.M Morales Meseguer
Murcia, 30008, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Universitario Vigen Del Rocío
Seville, 41013, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW, United Kingdom
Velindre Cancer Center
Cardiff, CF14 2TL, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, L7 8YA, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SJ, United Kingdom
Swansea Bay University Health Board
Swansea, SA2 8QA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Exelixis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 24, 2025
Study Start
July 21, 2025
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
August 7, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share