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Recruiting NCT06943755

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

Phase II / Phase III Interventional Pancreatic Neuroendocrine Tumor (pNET) Extra-Pancreatic Neuroendocrine Tumor (epNET)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zanzalintinib, Everolimus.
Who it may be relevant to
Registry conditions: Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Belgium, Canada +10
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Zanzalintinib
    Administered as specified in the treatment arm.
  • Drug Everolimus
    Administered as specified in the treatment arm.

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • PFS Per RECIST 1.1 as Assessed by Investigator [Time frame: Up to 48 months]
  • Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator [Time frame: Up to 48 months]
  • Overall Survival (OS) [Time frame: Up to 60 months]
  • Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator [Time frame: Up to 48 months]
  • Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator [Time frame: 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]
  • 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]
  • Number of Participants With Adverse Events [Time frame: Up to 48 months]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 40 centers
  • The University of Alabama at Birmingham — Birmingham
  • Mayo Clinic Hospital — Phoenix
  • The University of Arizona Cancer Center — Tucson
  • Cedars-Sinai Medical Center — Beverly Hills
  • Norris Comprehensive Cancer Center — Los Angeles
  • Stanford Cancer Center — Palo Alto
  • UCLA Health - Santa Monica Cancer Care — Santa Monica
  • Kaiser Permanente Medical Center — Vallejo
  • … and 32 more centers
Spain · 12 centers

Center list to be confirmed — check the primary protocol.

France · 11 centers
  • Centre Hospitalier Universitaire de Caen Normandie — Caen
  • CHU Beaujon — Clichy
  • Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Claude Huriez — Lille
  • Hospices Civils de Lyon — Lyon
  • Hôpital Timone — Marseille
  • CHU de Montpellier Hôpital Saint Eloi — Montpellier
  • Centre Hospitalier Universitaire Nantes — Nantes
  • Centre Eugéne Marquis — Rennes
  • … and 3 more centers
Italy · 9 centers
  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Caratte — Bologna
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST s.r.l. — Meldola
  • Humanitas Mirasole S.p.A. — Milan
  • Instituto Europeo di Oncologia — Milan
  • Istituto Nazionale Tumori IRCCS - Fondazione Pascale — Naples
  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga — Orbassano to
  • … and 3 more centers
United Kingdom · 9 centers

Center list to be confirmed — check the primary protocol.

Australia · 6 centers
  • Monash Health — Clayton
  • Royal Brisbane and Women's Hospital — Herston
  • Peter MacCallum Cancer Centre — Melbourne
  • Fiona Stanley Hospital — Murdoch
  • GenesisCare North Shore — St Leonards
  • The Queen Elizabeth Hospital — Woodville South
Germany · 5 centers
  • Evangelische Lungenklinik — Berlin
  • Universitätsklinik Erlangen — Erlangen
  • Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg — Marburg
  • Universitätsklinikum Tübingen — Tübingen
  • University Hospital Würzburg — Würzburg
Poland · 5 centers

Center list to be confirmed — check the primary protocol.

South Korea · 5 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 4 centers

Center list to be confirmed — check the primary protocol.

Austria · 3 centers
  • Medical University of Graz — Graz
  • Paracelsus Medical University Hospital Salzburg — Salzburg
  • Medical University of Vienna — Vienna
Belgium · 3 centers
  • Institut Jules Bordet — Brussels
  • UZ Leuven — Leuven
  • Cliniques Universitaires Saint-Luc (UCLouvain) — Woluwe-Saint-Lambert
Canada · 3 centers
  • Verspeeten Family Cancer Center - London Health Sciences Centre — London
  • The Ottawa Hospital Cancer Center — Ottawa
  • Sunnybrook Health Sciences Centre — Toronto
China · 3 centers
  • Humanity and Health Clinical Trial Centre — Hong Kong
  • Prince of Wales Hospital — Hong Kong
  • Queen Mary Hospital — Hong Kong
Puerto Rico · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06943755 · XL092-311 · 2025-521043-20-00 · 1011801

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗