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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to 48 months]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 40 центров

• 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
• … и ещё 32 центра

Испания · 12 центров

Список центров уточняется — проверьте первичный протокол.

Франция · 11 центров

• 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
• … и ещё 3 центра

Италия · 9 центров

• 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
• … и ещё 3 центра

Великобритания · 9 центров

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Австралия · 6 центров

• 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

Германия · 5 центров

• Evangelische Lungenklinik — Berlin
• Universitätsklinik Erlangen — Erlangen
• Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg — Marburg
• Universitätsklinikum Tübingen — Tübingen
• University Hospital Würzburg — Würzburg

Польша · 5 центров

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South Korea · 5 центров

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Нидерланды · 4 центра

Список центров уточняется — проверьте первичный протокол.

Австрия · 3 центра

• Medical University of Graz — Graz
• Paracelsus Medical University Hospital Salzburg — Salzburg
• Medical University of Vienna — Vienna

Бельгия · 3 центра

• Institut Jules Bordet — Brussels
• UZ Leuven — Leuven
• Cliniques Universitaires Saint-Luc (UCLouvain) — Woluwe-Saint-Lambert

Канада · 3 центра

• Verspeeten Family Cancer Center - London Health Sciences Centre — London
• The Ottawa Hospital Cancer Center — Ottawa
• Sunnybrook Health Sciences Centre — Toronto

Китай · 3 центра

• Humanity and Health Clinical Trial Centre — Гонконг
• Prince of Wales Hospital — Гонконг
• Queen Mary Hospital — Гонконг

Пуэрто-Рико · 2 центра

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Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗