Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors (STELLAR-311)

April 15, 2026 updated by: Exelixis

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Exelixis Clinical Trials
  • Phone Number: 1-888-EXELIXIS (888-393-5494)
  • Email: druginfo@exelixis.com

Study Contact Backup

  • Name: Backup or International
  • Phone Number: 650-837-7400

Study Locations

  • Australia
      • Herston, Australia, 4029
        • Recruiting
        • Exelixis Clinical Site #55
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Exelixis Clinical Site #40
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Recruiting
        • Exelixis Clinical Site #67
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Exelixis Clinical Site #51
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Exelixis Clinical Site #68
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Exelixis Clinical Site #48
  • Canada
      • Ottawa, Canada, K1H8L6
        • Recruiting
        • Exelixis Clinical Site #61
      • Toronto, Canada, M4N3M5
        • Recruiting
        • Exelixis Clinical Site #49
  • China
      • Hong Kong, China
        • Recruiting
        • Exelixis Clinical Site #63
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Exelixis Clinical Site 58
      • Tübingen, Germany, 72076
        • Recruiting
        • Exelixis Clinical Site #52
      • Würzburg, Germany, 97080
        • Recruiting
        • Exelixis Clinical Site #75
  • Hong Kong
      • China, Hong Kong
        • Recruiting
        • Exelixis Clinical Site #77
  • Italy
      • Roma, Italy, 00185
        • Recruiting
        • Exelixis Clinical Site #70
    • Naples
      • Naples, Naples, Italy, 80131
        • Recruiting
        • Exelixis Clinical Site #78
  • Poland
      • Katowice, Poland, 40-514
        • Recruiting
        • Exelixis Clinical Site #45
      • Warsaw, Poland, 53-673
        • Recruiting
        • Exelixis Clinical Site #37
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-034
        • Recruiting
        • Exelixis Clinical Site #69
    • Ślaskie
      • Gliwice, Ślaskie, Poland, 44-102
        • Recruiting
        • Exelixis Clinical Site #72
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Exelixis Clinical Site #2
      • San Juan, Puerto Rico, 00927
        • Withdrawn
        • Exelixis Clinical Site # 4
  • South Korea
      • Seoul, South Korea, 02841
        • Recruiting
        • Exelixis Clinical Site #30
      • Seoul, South Korea, 03722
        • Recruiting
        • Exelixis Clinical Site #32
      • Seoul, South Korea, 06351
        • Recruiting
        • Exelixis Clinical Site #26
      • Seoul, South Korea, 03080
        • Recruiting
        • Exelixis Clinical Site #46
      • Seoul, South Korea, 05505
        • Recruiting
        • Exelixis Clinical Site #41
  • Spain
      • Barcelona, Spain, 08029
        • Recruiting
        • Exelixis Clinical Site #76
      • Madrid, Spain, 28046
        • Recruiting
        • Exelixis Clinical Site #44
      • Madrid, Spain, 28034
        • Recruiting
        • Exelixis Clinical Site #56
      • Madrid, Spain, 28041
        • Recruiting
        • Exelixis Clinical Site #73
      • Murcia, Spain, 30008
        • Recruiting
        • Exelixis Clinical Site #66
      • Santander, Spain, 39008
        • Recruiting
        • Exelixis Clinical Site #60
      • Seville, Spain, 41013
        • Recruiting
        • Exelixis Clinical Site #62
      • Valencia, Spain, 46026
        • Recruiting
        • Exelixis Clinical Site #64
      • Zaragoza, Spain, 50009
        • Recruiting
        • Exelixis Clinical Site #79
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Recruiting
        • Exelixis Clinical Site #74
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Exelixis Clinical Site #80
  • United Kingdom
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • Exelixis Clinical Site #50
      • Sheffield, United Kingdom, S10 2SJ
        • Recruiting
        • Exelixis Clinical Site #33
    • England
      • London, England, United Kingdom, SE5 9RS
        • Recruiting
        • Exelixis Clinical Site #22
      • Oxford, England, United Kingdom, OX3 7LE
        • Recruiting
        • Exelixis Clinical Site #71
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Exelixis Clinical Site #43
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Exelixis Clinical Site #36
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • Exelixis Clinical Site #42
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Exelixis Clinical Site #18
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Exelixis Clinical Site #16
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Exelixis Clinical Site #54
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Exelixis Clinical Site #12
      • Vallejo, California, United States, 94589
        • Recruiting
        • Exelixis Clinical Site #29
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Exelixis Clinical Site #19
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Exelixis Clinical Site #35
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Exelixis Clinical Site #11
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • Exelixis Clinical Site #9
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Exelixis Clinical Site #23
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Exelixis Clinical Site #8
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Exelixis Clinical Site #47
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Exelixis Clinical Site #1
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Exelixis Clinical Site #38
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Exelixis Clinical Site #5
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Exelixis Clinical Site #25
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • Exelixis Clinical Site #14
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Exelixis Clinical Site #59
      • New York, New York, United States, 10029
        • Recruiting
        • Exelixis Clinical Site #7
      • Rochester, New York, United States, 14642
        • Recruiting
        • Exelixis Clinical Site #53
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Exelixis Clinical Site #17
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Exelixis Clinical Site #6
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Exelixis Clinical Site #57
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Exelixis Clinical Site #39
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Exelixis Clinical Site #28
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Exelixis Clinical Site #27
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Exelixis Clinical Site #20
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Exelixis Clinical Site #21
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • Exelixis Clinical Site #24
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Exelixis Clinical Site #65
    • Texas
      • Dallas, Texas, United States, 75264
        • Recruiting
        • Exelixis Clinical Site #10
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Exelixis Clinical Site #15
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • Exelixis Clinical Site #3
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Exelixis Clinical Site #13
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Exelixis Clinical Site #34
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Exelixis Clinical Site #31

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zanzalintinib
Participants will receive zanzalintinib oral tablets once daily.
Drug: Zanzalintinib
Administered as specified in the treatment arm.
Other Names:
  • XL092
Active Comparator: Everolimus
Participants will receive everolimus oral tablets once daily.
Drug: Everolimus
Administered as specified in the treatment arm.
Other Names:
  • Afinitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to 48 months
Up to 48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 60 months
Up to 60 months
PFS Per RECIST 1.1 as Assessed by Investigator
Time Frame: Up to 48 months
Up to 48 months
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator
Time Frame: Up to 48 months
Up to 48 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator
Time Frame: Up to 48 months
Up to 48 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator
Time Frame: Up to 48 months
Up to 48 months
Change From Baseline in Participant-Reported Global Health Status (GHS) and Disease-Related Symptoms as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score
Time Frame: Up to 48 months
Up to 48 months
Change From Baseline in Participant-Reported GHS and Disease-Related Symptoms as Assessed by EORTC Gastrointestinal Neuroendocrine Tumor module (QLQ-GI.NET21) Score
Time Frame: Up to 48 months
Up to 48 months
Number of Participants With Adverse Events
Time Frame: Up to 48 months
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Investigators

  • Study Director: Medical Director, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL092-311
  • 2025-521043-20-00 (Ctis)
  • 1011801 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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