RecruitingPhase 2Phase 3NCT06943755

Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

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

Sponsor

Exelixis

Enrollment

440 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Neuroendocrine Tumor (pNET)Extra-Pancreatic Neuroendocrine Tumor (epNET)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing zanzalintinib (a new oral targeted drug) with everolimus (a standard drug) in patients with advanced neuroendocrine tumors (NETs) — slow-growing tumors that start in hormone-producing cells — that have progressed on prior treatment. **You may be eligible if...** - You have confirmed advanced or metastatic well-differentiated neuroendocrine tumors (Grade 1, 2, or 3) from the pancreas or other sites - Your cancer progressed on imaging within the past 12 months - You have measurable disease on scans - You have received prior lines of treatment appropriate for your tumor type **You may NOT be eligible if...** - You have neuroendocrine carcinoma (a more aggressive type, including small cell lung cancer) - You have medullary thyroid cancer, pheochromocytoma, Merkel cell carcinoma, or mixed neuroendocrine tumors - You have previously received a VEGFR-targeting drug or everolimus - You have active brain metastases or serious organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanzalintinib

Administered as specified in the treatment arm.

DRUGEverolimus

Administered as specified in the treatment arm.

Locations(80)

Exelixis Clinical Site #43

Birmingham, Alabama, United States

Exelixis Clinical Site #36

Phoenix, Arizona, United States

Exelixis Clinical Site #42

Tucson, Arizona, United States

Exelixis Clinical Site #18

Beverly Hills, California, United States

Exelixis Clinical Site #16

Los Angeles, California, United States

Exelixis Clinical Site #54

Palo Alto, California, United States

Exelixis Clinical Site #12

Santa Monica, California, United States

Exelixis Clinical Site #29

Vallejo, California, United States

Exelixis Clinical Site #19

Washington D.C., District of Columbia, United States

Exelixis Clinical Site #35

Jacksonville, Florida, United States

Exelixis Clinical Site #11

Tampa, Florida, United States

Exelixis Clinical Site #9

Lexington, Kentucky, United States

Exelixis Clinical Site #23

Metairie, Louisiana, United States

Exelixis Clinical Site #8

Boston, Massachusetts, United States

Exelixis Clinical Site #47

Detroit, Michigan, United States

Exelixis Clinical Site #1

Grand Rapids, Michigan, United States

Exelixis Clinical Site #38

Rochester, Minnesota, United States

Exelixis Clinical Site #5

St Louis, Missouri, United States

Exelixis Clinical Site #25

Omaha, Nebraska, United States

Exelixis Clinical Site #14

Albuquerque, New Mexico, United States

Exelixis Clinical Site #59

Buffalo, New York, United States

Exelixis Clinical Site #7

New York, New York, United States

Exelixis Clinical Site #53

Rochester, New York, United States

Exelixis Clinical Site #17

Chapel Hill, North Carolina, United States

Exelixis Clinical Site #6

Durham, North Carolina, United States

Exelixis Clinical Site #57

Fargo, North Dakota, United States

Exelixis Clinical Site #39

Cleveland, Ohio, United States

Exelixis Clinical Site #28

Columbus, Ohio, United States

Exelixis Clinical Site #27

Portland, Oregon, United States

Exelixis Clinical Site #20

Philadelphia, Pennsylvania, United States

Exelixis Clinical Site #21

Pittsburgh, Pennsylvania, United States

Exelixis Clinical Site #24

Knoxville, Tennessee, United States

Exelixis Clinical Site #65

Nashville, Tennessee, United States

Exelixis Clinical Site #10

Dallas, Texas, United States

Exelixis Clinical Site #15

Salt Lake City, Utah, United States

Exelixis Clinical Site #3

Charlottesville, Virginia, United States

Exelixis Clinical Site #13

Fairfax, Virginia, United States

Exelixis Clinical Site #34

Seattle, Washington, United States

Exelixis Clinical Site #31

Milwaukee, Wisconsin, United States

Exelixis Clinical Site #40

Saint Leonards, New South Wales, Australia

Exelixis Clinical Site #67

Woodville South, South Australia, Australia

Exelixis Clinical Site #51

Clayton, Victoria, Australia

Exelixis Clinical Site #68

Clayton, Victoria, Australia

Exelixis Clinical Site #55

Herston, Australia

Exelixis Clinical Site #48

Graz, Austria

Exelixis Clinical Site #61

Ottawa, Canada

Exelixis Clinical Site #49

Toronto, Canada

Exelixis Clinical Site #63

Hong Kong, China

Exelixis Clinical Site 58

Berlin, Germany

Exelixis Clinical Site #52

Tübingen, Germany

Exelixis Clinical Site #75

Würzburg, Germany

Exelixis Clinical Site #77

China, Hong Kong

Exelixis Clinical Site #78

Naples, Naples, Italy

Exelixis Clinical Site #70

Roma, Italy

Exelixis Clinical Site #69

Warsaw, Masovian Voivodeship, Poland

Exelixis Clinical Site #45

Katowice, Poland

Exelixis Clinical Site #37

Warsaw, Poland

Exelixis Clinical Site #72

Gliwice, Ślaskie, Poland

Exelixis Clinical Site #2

San Juan, Puerto Rico

Exelixis Clinical Site # 4

San Juan, Puerto Rico

Exelixis Clinical Site #30

Seoul, South Korea

Exelixis Clinical Site #46

Seoul, South Korea

Exelixis Clinical Site #32

Seoul, South Korea

Exelixis Clinical Site #41

Seoul, South Korea

Exelixis Clinical Site #26

Seoul, South Korea

Exelixis Clinical Site #74

Santiago de Compostela, A Coruña, Spain

Exelixis Clinical Site #80

Oviedo, Principality of Asturias, Spain

Exelixis Clinical Site #76

Barcelona, Spain

Exelixis Clinical Site #56

Madrid, Spain

Exelixis Clinical Site #73

Madrid, Spain

Exelixis Clinical Site #44

Madrid, Spain

Exelixis Clinical Site #66

Murcia, Spain

Exelixis Clinical Site #60

Santander, Spain

Exelixis Clinical Site #62

Seville, Spain

Exelixis Clinical Site #64

Valencia, Spain

Exelixis Clinical Site #79

Zaragoza, Spain

Exelixis Clinical Site #22

London, England, United Kingdom

Exelixis Clinical Site #71

Oxford, England, United Kingdom

Exelixis Clinical Site #50

Liverpool, United Kingdom

Exelixis Clinical Site #33

Sheffield, United Kingdom

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NCT06943755