A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Telisotuzumab Adizutecan, Standard of Care, Osimertinib.
- Кому может быть актуально
- Состояния в реестре: Non-Small Cell Lung Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австралия, Австрия, Бельгия, Китай +14
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
Обзор
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Вмешательства
- Препарат Telisotuzumab Adizutecan
Intravenous (IV) Infusion - Препарат Standard of Care
Standard of Care - Препарат Osimertinib
Oral
Первичные конечные точки
- Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR) [Срок оценки: Up to Approximately 69 Months]
- Phase 3: Progression-Free Survival (PFS) as assessed by the BICR [Срок оценки: Up to Approximately 69 Months]
Вторичные конечные точки (8)
- Phase 2 and 3: Overall Survival (OS) [Срок оценки: Up to Approximately 69 Months]
- Phase 2: PFS as assessed by the BICR [Срок оценки: Up to Approximately 69 Months]
- Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1 [Срок оценки: Up to Approximately 69 Months]
- Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1 [Срок оценки: Up to Approximately 69 Months]
- Phase 3: OR Assessed by the BICR [Срок оценки: Up to Approximately 69 Months]
- Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) [Срок оценки: Up to Week 12]
- Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13) [Срок оценки: Up to Week 12]
- Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30 [Срок оценки: Up to Week 12]
Критерии участия
Критерии включения
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
- Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable.
- Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
Критерии исключения
- Tumor(s) have adenosquamous or squamous histology or sarcomatoid features.
- Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
- Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable.
- Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids.
- Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
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 · 15 центров
- Highlands Oncology Group - Springdale /ID# 277132 — Springdale
- City of Hope National Medical Center /ID# 277005 — Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928 — Irvine
- Cancer Specialists of North Florida /ID# 277332 — Jacksonville
- Cancer Care Centers of Brevard- Rockledge /ID# 277853 — Rockledge
- Moffitt Cancer Center /ID# 276785 — Tampa
- Parkview Research Center /ID# 277651 — Fort Wayne
- HealthPartners Cancer Research Center /ID# 277339 — Saint Louis Park
- … и ещё 7 центров
Италия · 8 центров
- Istituto Europeo Di Oncologia /ID# 276788 — Milan
- AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338 — Fano
- Centro Di Riferimento Oncologico /ID# 276923 — Aviano
- IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 27729 — Rome
- Ospedale Isola Tiberina - Gemelli Isola /ID# 277117 — Rome
- Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119 — Candiolo
- AOU Policlinico G. Rodolico - San Marco /ID# 277265 — Catania
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280 — Verona
Испания · 8 центров
Список центров уточняется — проверьте первичный протокол.
Тайвань · 8 центров
Список центров уточняется — проверьте первичный протокол.
Австралия · 7 центров
- Canberra Hospital /ID# 277166 — Garran
- St George Hospital - Kogarah /ID# 277168 — Kogarah
- Mater Hospital Brisbane /ID# 276985 — South Brisbane
- Icon Cancer Centre Hobart /ID# 277549 — Hobart
- St Vincent's Hospital Melbourne /ID# 277002 — Fitzroy
- Sunshine Hospital /ID# 276894 — St Albans
- One Clinical Research - Nedlands /ID# 277598 — Nedlands
Turkey (Türkiye) · 7 центров
Список центров уточняется — проверьте первичный протокол.
Германия · 6 центров
- Universitaetsklinikum Heidelberg /ID# 277275 — Heidelberg
- Universitaetsklinikum Wuerzburg /ID# 277213 — Würzburg
- Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873 — Marburg
- Universitaetsklinikum Koeln /ID# 276862 — Cologne
- Universitätsklinikum Jena /ID# 277281 — Jena
- Universitaetsklinikum Hamburg-Eppendorf /ID# 276869 — Hamburg
Португалия · 6 центров
- Unidade Local de Saude do Alto Ave, EPE /ID# 277249 — Guimarães
- Unidade Local de Saude de Loures-Odivelas /ID# 277223 — Loures
- Unidade Local de Saude de Matosinhos EPE /ID# 277228 — Senhora da Hora
- Unidade Local de Saude de Braga, EPE /ID# 277217 — Braga
- Unidade Local de Saude de Santo Antonio /ID# 277216 — Porto
- Hospital Cuf Porto /ID# 277225 — Porto
South Korea · 6 центров
- National Cancer Center /ID# 277353 — Goyang-si
- … и ещё 5 центров
Бельгия · 5 центров
- Institut Jules Bordet /ID# 277283 — Anderlecht
- Grand Hopital de Charleroi - Les Viviers /ID# 277282 — Charleroi
- Groupe Sante CHC - Clinique du MontLegia /ID# 278951 — Liège
- Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202 — Hasselt
- Universitair Ziekenhuis Leuven /ID# 276874 — Leuven
Израиль · 5 центров
- Meir Medical Center /ID# 277289 — Kefar Sava
- Rabin Medical Center /ID# 276748 — Petah Tikva
- Yitzhak Shamir Medical Center /ID# 276750 — Ẕerifin
- The Chaim Sheba Medical Center /ID# 276745 — Ramat Gan
- Rambam Health Care Campus- Haifa /ID# 276746 — Haifa
Польша · 5 центров
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 2770 — Poznan
- Pratia MCM Krakow /ID# 277118 — Krakow
- Provita Centrum Medyczne /ID# 277494 — Warsaw
- Uniwersyteckie Centrum Kliniczne /ID# 277210 — Gdansk
- Gyncentrum Sp. z o.o. /ID# 277522 — Sosnowiec
Сербия · 5 центров
- University Clinical Center Serbia /ID# 277051 — Belgrade
- Clinical Hospital Center - Bežanijska Kosa /ID# 277052 — Belgrade
- University Clinical Center Nis /ID# 277200 — Niš
- Institute For Pulmonary Diseases Of Vojvodina /ID# 277047 — Kamenitz
- University Clinical Center Kragujevac /ID# 277162 — Kragujevac
Китай · 4 центра
- Guangdong Provincial People's Hospital /ID# 277631 — Гуанчжоу
- The First affiliated hospital of Nanchang University (Xianghu campus) /ID# 277491 — Nanchang
- Shanghai Pulmonary Hospital /ID# 277488 — Шанхай
- Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638 — Ürümqi
Франция · 4 центра
- CHU Brest - Hopital de la Cavale Blanche /ID# 277883 — Brest
- CHU de Lille - Institut Coeur Poumon /ID# 276868 — Lille
- Hopital Arnaud de Villeneuve /ID# 276872 — Montpellier
- Institut Curie /ID# 277623 — Paris
Япония · 4 центра
- Hokkaido University Hospital /ID# 277240 — Sapporo
- Kitasato University Hospital /ID# 277241 — Sagamihara-shi
- National Cancer Center Hospital /ID# 277093 — Chuo-Ku
- Wakayama Medical University Hospital /ID# 277238 — Wakayama
Нидерланды · 4 центра
- Radboudumc /ID# 277639 — Nijmegen
- Leids Universitair Medisch Centrum /ID# 277270 — Leiden
- Erasmus Medisch Centrum /ID# 276989 — Rotterdam
- Universitair Medisch Centrum Utrecht /ID# 277114 — Utrecht
Великобритания · 2 центра
Список центров уточняется — проверьте первичный протокол.
Австрия · 1 центр
- Klinik Floridsdorf /ID# 276679 — Vienna
Идентификаторы
NCT: NCT07155187 · M25-713 · 2025-521124-29