Исследование Dato-DXd Plus Pembrolizumab по сравнению с монотерапией пембролизумабом в терапии первой линии у субъектов с распространенным или метастатическим НМРЛ без действенных геномных изменений (TROPION-Lung08)
Рандомизированное открытое исследование фазы 3 комбинации Dato-DXd плюс пембролизумаб в сравнении с монотерапией пембролизумабом у ранее не получавших лечения субъектов с прогрессирующим или метастатическим PD-L1 с высоким (TPS ≥50%) немелкоклеточным раком легкого без действенных геномных изменений (TROPION) -Легкое08)
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) by BICR or Overall Survival (OS) for participants with advanced or metastatic NSCLC with non-squamous histology without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC.
Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and Follow-up Period.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Camperdown, Австралия, 2050
- Chris Obrien Lifehouse
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Woodville South, Австралия, 5011
- The Queen Elizabeth Hospital
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Victoria
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Heidelberg, Victoria, Австралия, 3084
- Austin Hospital
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Mount Waverley, Victoria, Австралия, 3149
- Peninsula and South Eastern Haematology and Oncology Group
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Klagenfurt, Австрия
- Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
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Vienna, Австрия, 1090
- Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
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Buenos Aires, Аргентина
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
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Ciudad Autonoma de Buenos Aire, Аргентина, 1125
- Fundacion CENIT para la investigación en Neurociencias
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Mar del Plata, Аргентина, B7602CBM
- Hospital Privado de la Comunidad
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Pergamino, Аргентина, 2700
- Centro de Investigación Pergamino S. A.
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Rosario, Аргентина, S2001
- Sanatorio Parque
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Rosario, Аргентина, S2000
- Instituto de Oncología de Rosario
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Rosario, Аргентина, S2002
- Sanatorio Británico de Rosario
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San Juan, Аргентина, 5400
- CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
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Viedma, Аргентина, 8500
- Clinica Viedma SA
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Aalst, Бельгия, 9300
- Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
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Charleroi, Бельгия, 6000
- Grand Hopital de Charleroi - Hopital Saint Joseph
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Ghent, Бельгия, 9000
- Az Maria Middelares - Campus Maria Middelares
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Sint-Niklaas, Бельгия, 9100
- AZ Nikolaas
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Caxias do Sul, Бразилия, 95020-972
- Instituto de Pesquisas em Saúde - IPS
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Curitiba, Бразилия, 81520-060
- Hospital Erasto Gaertner
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Ijuí, Бразилия, 98700-000
- Oncosite - Centro de Pesquisa Clinica Oncologia
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Itajaí, Бразилия, 88301-220
- Clínica de Neoplasias Litoral
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Pelotas, Бразилия, 96020-080
- UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
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Porto Alegre, Бразилия, 90050-170
- Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Бразилия, 20231-050
- Instituto Nacional de Câncer - INCA
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Santo André, Бразилия, 09060-870
- Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
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São Paulo, Бразилия, 01236-030
- Instituto de Ensino e Pesquisas Sao Lucas
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Taubaté, Бразилия
- Instituto do Cancer Brasil - Unidade Taubate
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Budapest, Венгрия, 1083
- Semmelweis University Department of Pulmonology
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Farkasgyepű, Венгрия, 8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
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KecskemĂŠt, Венгрия, 6000
- Bkmk Hospital
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Székesfehérvár, Венгрия, 8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Törökbálint, Венгрия, 2045
- Pulmonology Hospital Torokbalint
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Berlin, Германия, 13125
- Evangelische Lungenklinik Berlin
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Esslingen am Neckar, Германия, 73730
- Klinikum Esslingen GmbH
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Großhansdorf, Германия, 22927
- LungenClinic Grosshansdorf
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München, Германия, 80336
- Klinikum der Universitaet Muenchen
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Hong Kong, Гонконг
- Queen Elizabeth Hospital
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Hong Kong, Гонконг, 99999
- Prince of Wales Hospital / The Chinese University of Hong Kong 99999
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Pok Fu Lam, Гонконг, 999077
- Queen Mary Hospital
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Athens, Греция, 11527
- Sotiria General Hosptial of Chest Diseases
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Ioannina, Греция, 45500
- University Hospital of Ioannina Uhi
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Neo Faliro, Греция, 18547
- Metropolitan Hospital
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Piraeus, Греция, 18547
- Metropolitan Hospital
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Thessaloniki, Греция, 54622
- Bioclinic Thessaloniki
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Thessaloniki, Греция, 55236
- St. Luke's Hospital
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Athens
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Neo Faliro, Athens, Греция, 14564
- Metropolitan Hospital
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Barcelona, Испания, 08036
- Hospital Clinic i Provincial de Barcelona
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Barcelona, Испания, 8035
- Hospital Universitari Vall D'Hebron
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Lleida, Испания, 25198
- Hospital Universitario Arnau de Vilanova - Lleida
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Madrid, Испания, 28040
- Hospital Clinico San Carlos
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Madrid, Испания, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Испания, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Málaga, Испания, 29010
- Hospital Regional Universitario Malaga
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Ourense, Испания, 32005
- CHUO
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Seville, Испания, 41009
- Hospital Universitario Virgen Macarena
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Seville, Испания, 41014
- Hospital Universitario de Valme
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Valencia, Испания, 46026
- Hospital Universitari i Politècnic La Fe
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Zaragoza, Испания, 50009
- Hospital Universitario Miguel Servet
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Bari, Италия, 70124
- IRCCS Istituto Oncologico Giovanni Paolo II
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Chieti, Италия, 66100
- UOC Oncologia
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Lucca, Италия, 55100
- Ospedale San Luca
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Milan, Италия, 20132
- IRCCS Ospedale San Raffaele
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Milan, Италия, 20141
- Irccs Istituto Europeo Di Oncologia
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Naples, Италия, 80131
- Azienda Ospedaliera dei Colli
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Perugia, Италия, 06132
- A.O. Perugia Santa Maria della Misericordia
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Rome, Италия, 133
- Policlinico Tor Vergata
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Rome, Италия, 144
- Ifo Regina Elena
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Varese, Италия, 21100
- Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
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Montreal, Канада, H4A 3J2
- McGill University Health Centre
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Beijing, Китай, 100142
- Peking University Cancer Hospital
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Beijing, Китай, 100044
- Peking University Peoples Hospital
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Cangzhou, Китай, 610001
- Cangzhou People's Hospital
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Changsha, Китай, 410013
- Hunan Cancer Hospital
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Chongqing, Китай, 400042
- Army Medical Center of PLA
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Guangzhou, Китай, 510095
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University
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Haikou, Китай, 570208
- Haikou People's Hospital
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Hanghzou, Китай, 310003
- The First Affiliated Hospital of College of Medicine Zhejiang University
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Harbin, Китай, 150081
- Harbin Medical University Cancer Hospital
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Hohhot, Китай, 10050
- Inner Mongolia Medical University- the Affiliated Hospital
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Jiamusi, Китай, 154007
- Jiamusi Tumor and Tuberculosis Hospital
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Kunming, Китай, 650118
- Yunnan Cancer Hospital
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Linyi, Китай, 276000
- Linyi Cancer Hospital
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Nanchang, Китай, 330006
- The First Affiliated Hospital of Nanchang University
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Nanjing, Китай, 210029
- Jiangsu Province Hospital
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Neijiang, Китай, 641000
- The Second People's Hospital of Neijiang
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Shanghai, Китай, 200433
- Shanghai Pulmonary Hospital
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Shanghai Shi, Китай, 200032
- Fudan University Shanghai Cancer Center
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Shenyang, Китай, 110001
- The First Hospital of China Medical University
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Shenyang, Китай, 110801
- Liaoning Cancer Hospital& Institute
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Tianjin, Китай, 300052
- Tianjin Medical University General Hospital
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Wuhan, Китай, 430079
- Hubei Cancer Hospital
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Wuhan, Китай, 430022
- Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
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Xi'an, Китай, 710061
- The First Affiliate Hospitalof Xi'An Jiaotong University
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Xiamen, Китай, 361001
- The First Affiliated Hospital Xiamen University
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Xiangyang, Китай, 441000
- Xiangyang Central Hospital- 5 Lumen Avenue
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Ürümqi, Китай, 830000
- Xinjiang Tumor Hospital
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Guangxi
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Nanning, Guangxi, Китай, 530021
- Guangxi Medical University Affiliated Tumor Hospital
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Henan
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Zhengzhou, Henan, Китай, 450008
- Henan Cancer Hospital
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Jilin
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Changchun, Jilin, Китай, 130012
- Jilin Cancer Hospital
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Sichuan
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Chengdu, Sichuan, Китай, 610049
- Sichuan Cancer Hospital
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Cuauhtémoc, Мексика, 06100
- Cryptex Investigacion Clinica Sa de Cv
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Guadalajara, Мексика, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Monterrey, Мексика, 64460
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
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Oaxaca City, Мексика, 68020
- Centro de Investigacion Clinica de Oaxaca (CICLO)
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San Luis Potosí City, Мексика, 78209
- Oncologico Potosino
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's-Hertogenbosch, Нидерланды, 5223 GZ
- Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
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Amsterdam, Нидерланды, 1081 HZ
- Amsterdam Umc, Location Vumc
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Leiden, Нидерланды, 2333 ZA
- Leiden University Medical Center
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Gelderland
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Arnhem, Gelderland, Нидерланды, 6815 AD
- Rijnstate Ziekenhuis
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Bialystok, Польша, 15-450
- II Klinika Chorob Pluc I Gruzlicy
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Lublin, Польша, 20-064
- MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
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Iodzkie
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Lodz, Iodzkie, Польша, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Польша, 81-519
- Szpitale Pomorskie Sp. z o.o.
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Польша, 70-784
- Dom Lekarski SA
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Lisbon, Португалия, 1400-038
- Centro Clinico Champalimau
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Porto, Португалия, 4100-180
- Hospital CUF Porto
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Porto, Португалия, 4099-001
- Centro Hospitalar e Universitário do Porto
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Porto, Португалия, 4200-072
- Instituto Portuguas de Oncologia do Porto Francisco Gentil
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Porto, Португалия, 4200-319
- Centro Hospitalar Universitário de São João
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Craiova, Румыния, 200094
- Onco Clinic Consult SA
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Craiova, Румыния, 200542
- Centrul de Oncologie Sf Nectarie S.R.L.
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Suceava, Румыния, 720214
- Sc Sigmedical Services Srl
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Timișoara, Румыния, 300166
- Oncocenter-Oncologie Clinica SRL
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Timișoara, Румыния, 300239
- SC Oncomed SRL
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Birmingham, Соединенное Королевство, B9 5SS
- Birmingham Heartlands Hospital
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Nottingham, Соединенное Королевство, NG5 1PB
- Nottingham University Hospitals
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Arizona
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Chandler, Arizona, Соединенные Штаты, 85224
- Ironwood Cancer and Research Center
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California
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Los Angeles, California, Соединенные Штаты, 90095
- UCLA HemOnc - Clinical Research Unit
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Santa Barbara, California, Соединенные Штаты, 93105
- Ridley-Tree Cancer Center
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Whittier, California, Соединенные Штаты, 90603
- The Oncology Institute of Hope and Innovation
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Whittier, California, Соединенные Штаты, 90602
- PIH Health Whittier Hospital
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Colorado
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Colorado Springs, Colorado, Соединенные Штаты, 80909
- Uch-Mhs D/B/A Memorial Health System
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21205
- Johns Hopkins University
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Bethesda, Maryland, Соединенные Штаты, 20817
- American Oncology Partners of Maryland
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Соединенные Штаты, 02115
- Dana-Farber Cancer Institute
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Foxborough, Massachusetts, Соединенные Штаты, 02035
- Dana Farber Cancer Institute - Foxborough
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South Weymouth, Massachusetts, Соединенные Штаты, 02190
- DFCI - South Shore Hospital
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New Hampshire
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Lebanon, New Hampshire, Соединенные Штаты, 03766
- Dartmouth Hitchcock Medical Center
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New Jersey
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East Brunswick, New Jersey, Соединенные Штаты, 08816
- Astera Cancer Care
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Freehold, New Jersey, Соединенные Штаты, 07728
- Regional Cancer Care Associates LLC
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New Brunswick, New Jersey, Соединенные Штаты, 08901
- Cooperman Barnabas Medical Center
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Paramus, New Jersey, Соединенные Штаты, 07652
- The Valley Hospital
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New York
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The Bronx, New York, Соединенные Штаты, 10461
- Montefiore Medical Center
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Texas
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Irving, Texas, Соединенные Штаты, 75063
- Arizona Oncology NAHOA
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Irving, Texas, Соединенные Штаты, 75063
- Cancer Care Center of Brevard
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Irving, Texas, Соединенные Штаты, 75063
- Illinois Cancer Specialists
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Irving, Texas, Соединенные Штаты, 75063
- Maryland Oncology Hematology
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Irving, Texas, Соединенные Штаты, 75063
- Southern Cancer Center
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Irving, Texas, Соединенные Штаты, 75063
- Texas Oncology - Northeast Texas
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Irving, Texas, Соединенные Штаты, 75063
- Texas Oncology Gulf Coast
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Irving, Texas, Соединенные Штаты, 75063
- Texas Oncology McAllen
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San Antonio, Texas, Соединенные Штаты, 78229
- University of Texas Health Science Center San Antonio
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84106
- Utah Cancer Specialists
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Washington
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Lacey, Washington, Соединенные Штаты, 98503
- Providence Regional Cancer System
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Seattle, Washington, Соединенные Штаты, 98108
- VA Puget Sound Health Care System - VAPSHCS
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Medical College of Wisconsin
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Bangkok, Таиланд, 10700
- Siriraj Hospital
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Bangkok, Таиланд, 10330
- Faculty of Medicine Chulalongkorn University
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Changwat Khon Kaen
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Muaeng, Changwat Khon Kaen, Таиланд, 40002
- Srinagarind Hospital
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Таиланд, 90110
- Prince of Songkla University PSU - Faculty of Medicine
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Kaohsiung City, Тайвань, 824
- E-Da Hospital
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Kaohsiung City, Тайвань, 833
- Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
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Taichung, Тайвань, 40705
- Taichung Veterans General Hospital
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Taichung, Тайвань, 40201
- Chung Shan Medical University Hospital
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Tainan, Тайвань, 704
- National Cheng Kung University Hospital Nckuh
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Taipei, Тайвань, 100
- National Taiwan University Hospital
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Taipei, Тайвань, 11217
- Taipei Veterans General Hospital
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Taipei, Тайвань, 112
- Koo Foundation Sun Yat-Sen Cancer Center
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Taoyuan, Тайвань, 333
- Chang Gung Memorial Hospital LinKou
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Adana, Турция (Туркие), 1130
- Adana Acibadem Hospital
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Antalya, Турция (Туркие), 7070
- Akdeniz University Hospital
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Bornova-İzmir, Турция (Туркие), 35100
- Ege University
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Istanbul, Турция (Туркие), 34772
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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Seyhan /Adana, Турция (Туркие), 1140
- Medical Park Seyhan Hospital
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Çankaya, Турция (Туркие), 06520
- Memorial Ankara Hospital Ankara
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Avignon, Франция, 84000
- Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
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Bordeaux, Франция, 33076
- Institut Bergonie
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Bordeaux, Франция, 33075
- Bordeaux University Hospital - Hopital Saint Andre
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Lille, Франция, 59000
- Centre Hospitalier Universitaire de Lille
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Lyon, Франция, 69008
- Centre Leon Berard
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Marseille, Франция, 13273
- Institut Paoli-Calmettes
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Marseille, Франция, 13015
- APHM - Hopital Nord
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Montpellier, Франция, 34295
- Centre Hospitalier Universitaire de Montpellier
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Nantes, Франция, 44093
- CHU de Nantes
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Nantes, Франция, 44277
- Hopital prive du Confluent
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Paris, Франция, 75970
- AP-HP - Hopital Tenon
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Poitiers, Франция, 86000
- CHU de Poitier Pole Regional de Cancerologie
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Suresnes, Франция, 92150
- Hopital FOCH
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Santiago, Чили, 7500000
- Oncovida
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Santiago, Чили, 7500921
- Fundación Arturo Pérez López
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Santiago, Чили, 7501010
- Orlandi Oncología
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Viña del Mar, Чили, 254-0488
- Centro de Investigaciones Clinicas Vina Del Mar
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Чили, 7500653
- Centro de Estudios Clínicos SAGA
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Baden, Швейцария, 5404
- Kantonsspital Baden
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Basel, Швейцария, 4031
- University Hospital Basel
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Liestal, Швейцария, A4410
- Kantonsspital Baselland
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Sankt Gallen, Швейцария
- Kantonsspital St. Gallen
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Daegu, Южная Корея, 42119
- Kyungpook National University Chilgok Hospital
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Goyang-si, Южная Корея, 10408
- National Cancer Center
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Seoul, Южная Корея, 6351
- Samsung Medical Center
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Seoul, Южная Корея, 6591
- The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
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Songpa-gu, Южная Корея, 5505
- Asan Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Южная Корея, 13620
- Seoul National University Bundang Hospital
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Gyeongsangnam-do
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Jinju, Gyeongsangnam-do, Южная Корея, 52727
- Gyeongsang National University Hospital
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North Chungcheong
-
Cheongju-si, North Chungcheong, Южная Корея, 28644
- Chungbuk National University Hospital
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Kofu, Япония
- Yamanashi Prefectural Central Hospital
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Kyoto, Япония, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Osaka, Япония, 560-8552
- Osaka Toneyama Medical Center
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Sapporo, Япония, 006-8555
- Teine Keijinkai Hospital
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Aomori
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Aomori, Aomori, Япония, 030-8553
- Aomori Prefectural Central Hospital
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Chiba
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Kashiwa-shi, Chiba, Япония, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Япония, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Япония, 812-8582
- Kyushu University Hospital
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Fukuoka, Fukuoka, Япония, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Kurume-shi, Fukuoka, Япония, 830-0011
- Kurume University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Япония, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Япония, 241-8515
- Kanagawa Cancer Center
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Kumamoto
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Kumamoto, Kumamoto, Япония, 861- 4193
- Saiseikai Kumamoto Hospital
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Mie-ken
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Matsusaka-shi, Mie-ken, Япония, 515-8544
- Matsusaka Municipal Hospital
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Miyagi
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Sendai, Miyagi, Япония, 980-0873
- Sendai Kousei Hospital
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Niigata
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Niigata, Niigata, Япония, 961-8566
- Niigata Cancer Center Hospital
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Osaka
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Hirakata-shi, Osaka, Япония, 573-1191
- Kansai Medical University Hospital
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Osaka, Osaka, Япония, 541-8567
- Osaka International Cancer Institute
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Sakai-shi, Osaka, Япония, 591-8555
- NHO Kinki-Chuo Chest Medical Center
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Tochigi
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Shimotsuga-gun, Tochigi, Япония, 321-0293
- Dokkyo Medical University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Япония, 113-8431
- Juntendo University Hospital
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Bunkyō-Ku, Tokyo, Япония, 113-8677
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Toyko
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Kōtoku, Toyko, Япония, 135-8550
- The Cancer Institute Hospital of JFCR
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Ōta-ku, Toyko, Япония, 143-8541
- Toho University Omori Medical Center
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Yamaguchi
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Iwakuni-shi, Yamaguchi, Япония, 740-8510
- NHO Iwakuni Clinical Center
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Ube-shi, Yamaguchi, Япония, 755-0241
- Yamaguchi-Ube Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.
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Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
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Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
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Histologically documented non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0):
- Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study.
- Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations (AGAs) based on analysis of tumor tissue. If test results for EGFR, ALK, and ROS1 are not available, subjects are required to undergo testing performed locally for these genomic alterations.
- No known AGAs in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies in the first-line setting. (Testing for genomic alterations besides EGFR, ALK, and ROS1 is not required prior to randomization). Subjects whose tumors harbor KRAS mutations are eligible for the study.
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Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
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Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
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Has an adequate treatment washout period before Cycle 1 Day 1.
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Measurable disease based on local imaging assessment using RECIST Version 1.1.
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Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
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Has a life expectancy of at least 3 months.
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Adequate bone marrow function within 7 days before randomization.
Exclusion Criteria:
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Has received prior systemic treatment for advanced or metastatic NSCLC.
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Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadjuvant setting:
- Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
- TROP2-targeted therapy.
- Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
- Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
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Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases and who are asymptomatic may participate provided they are radiologically stable.
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Has received prior radiotherapy < 4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.
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History of another primary malignancy (beyond NSCLC) except for:
- Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
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Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
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Clinically severe pulmonary compromise, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.
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Uncontrolled or significant cardiovascular disease, including:
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 ms regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
- Myocardial infarction within 6 months prior to randomization.
- Uncontrolled angina pectoris within 6 months prior to randomization.
- LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
- New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
- Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.
Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
- Clinically significant corneal disease.
- Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
- Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
- Has known human immunodeficiency virus (HIV) infection that is not well controlled.
- Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.
- Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Had an allogeneic tissue/solid organ transplant.
- Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)
Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd. |
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Другие имена:
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Другие имена:
|
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Активный компаратор: Pembrolizumb
Participants will be randomized to receive 200 mg pembrolizumab. |
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Временное ограничение: From randomization until disease progression or death (whichever occurs first), up to approximately 46 months
|
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. |
From randomization until disease progression or death (whichever occurs first), up to approximately 46 months
|
|
Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Временное ограничение: From randomization until date of death due to any cause, up to approximately 72 months
|
Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
From randomization until date of death due to any cause, up to approximately 72 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
Временное ограничение: From randomization until disease progression or death (whichever occurs first), up to approximately 72 months
|
PFS is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. |
From randomization until disease progression or death (whichever occurs first), up to approximately 72 months
|
|
OS in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
Временное ограничение: From randomization until date of death due to any cause, up to approximately 72 months
|
Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
From randomization until date of death due to any cause, up to approximately 72 months
|
|
OS in All Randomized Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+) Participants
Временное ограничение: From randomization until date of death due to any cause, up to approximately 72 months
|
Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
From randomization until date of death due to any cause, up to approximately 72 months
|
|
OS in All Randomized Participants
Временное ограничение: From randomization until date of death due to any cause, up to approximately 72 months
|
Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
From randomization until date of death due to any cause, up to approximately 72 months
|
|
PFS Based on BICR in All Randomized Participants With Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
Временное ограничение: From randomization until disease progression or death (whichever occurs first), up to approximately 46 months
|
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR per RECIST Version 1.1. |
From randomization until disease progression or death (whichever occurs first), up to approximately 46 months
|
|
PFS Based on BICR in All Randomized Participants
Временное ограничение: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months
|
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR per RECIST Version 1.1. |
From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months
|
|
PFS Based on Investigator in Participants With Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+
Временное ограничение: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months
|
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by Investigator per RECIST Version 1.1. |
From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months
|
|
Progression-free Survival 2 (PFS2) in Participants With Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+
Временное ограничение: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months
|
PFS2 is defined as the time from date of randomization to the first documented disease progression on next-line therapy or death due to any cause, whichever occurs first. |
From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months
|
|
ORR by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+
Временное ограничение: From randomization to first confirmed response, up to approximately 72 months
|
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR and by the Investigator per RECIST Version 1.1. |
From randomization to first confirmed response, up to approximately 72 months
|
|
Duration of Response by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+
Временное ограничение: From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 72 months
|
Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1. |
From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 72 months
|
|
Time to Response by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+
Временное ограничение: From randomization to date of first objective response (CR or PR), up to approximately 72 months
|
Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1. |
From randomization to date of first objective response (CR or PR), up to approximately 72 months
|
|
Disease Control Rate by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+
Временное ограничение: From randomization until disease progression or death (whichever occurs first), up to approximately 72 months
|
Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1. |
From randomization until disease progression or death (whichever occurs first), up to approximately 72 months
|
|
Time to Deterioration in Participants with Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+
Временное ограничение: From randomization to first confirmed clinically meaningful symptom deterioration, up to 72 months
|
Time to Deterioration (TTD) is defined as the time from randomization to first onset of a ≥10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent ≥10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a ≥10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13). |
From randomization to first confirmed clinically meaningful symptom deterioration, up to 72 months
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE) with Non-Squamous Histology, and Separately for All Randomized Participants
Временное ограничение: Up to 72 months
|
A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment. |
Up to 72 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA for Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Временное ограничение: Baseline and up to 72 months
|
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. |
Baseline and up to 72 months
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Global Clinical Leader, Daiichi Sankyo
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- DS1062-A-U304
- 2021-002555-10 (Номер EudraCT)
- KEYNOTE-C73 (Другой идентификатор: Merck)
- MK3475-C73 (Другой идентификатор: Merck)
- 2023-507933-12-00 (Ктис)
- 2023 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Сроки обмена IPD
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Критерии совместного доступа к IPD
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .