Dato-DXd 加 Pembrolizumab 与单独 Pembrolizumab 一线治疗无可操作基因组改变的晚期或转移性 NSCLC 受试者的研究 (TROPION-Lung08)
Dato-DXd 加 Pembrolizumab 与 Pembrolizumab 单独治疗初治晚期或转移性 PD-L1 高 (TPS ≥50%) 无可操作基因组改变的非小细胞肺癌受试者的随机、开放标签、3 期试验 (TROPION -肺08)
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).
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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-
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Beijing、中国、100142
- Peking University Cancer Hospital
-
Beijing、中国、100044
- Peking University Peoples Hospital
-
Cangzhou、中国、610001
- Cangzhou People's Hospital
-
Changsha、中国、410013
- Hunan Cancer Hospital
-
Chongqing、中国、400042
- Army Medical Center of PLA
-
Guangzhou、中国、510095
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University
-
Haikou、中国、570208
- Haikou People's Hospital
-
Hanghzou、中国、310003
- The First Affiliated Hospital of College of Medicine Zhejiang University
-
Harbin、中国、150081
- Harbin Medical University Cancer Hospital
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Hohhot、中国、10050
- Inner Mongolia Medical University- the Affiliated Hospital
-
Jiamusi、中国、154007
- Jiamusi Tumor and Tuberculosis Hospital
-
Kunming、中国、650118
- Yunnan Cancer Hospital
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Linyi、中国、276000
- Linyi Cancer Hospital
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Nanchang、中国、330006
- The First Affiliated Hospital of Nanchang University
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Nanjing、中国、210029
- Jiangsu Province Hospital
-
Neijiang、中国、641000
- The Second People's Hospital of Neijiang
-
Shanghai、中国、200433
- Shanghai Pulmonary Hospital
-
Shanghai Shi、中国、200032
- Fudan University Shanghai Cancer Center
-
Shenyang、中国、110001
- The First Hospital of China Medical University
-
Shenyang、中国、110801
- Liaoning Cancer Hospital& Institute
-
Tianjin、中国、300052
- Tianjin Medical University General Hospital
-
Wuhan、中国、430079
- Hubei Cancer Hospital
-
Wuhan、中国、430022
- Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
-
Xi'an、中国、710061
- The First Affiliate Hospitalof Xi'An Jiaotong University
-
Xiamen、中国、361001
- The First Affiliated Hospital Xiamen University
-
Xiangyang、中国、441000
- Xiangyang Central Hospital- 5 Lumen Avenue
-
Ürümqi、中国、830000
- Xinjiang Tumor Hospital
-
-
Guangxi
-
Nanning、Guangxi、中国、530021
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Henan
-
Zhengzhou、Henan、中国、450008
- Henan Cancer Hospital
-
-
Jilin
-
Changchun、Jilin、中国、130012
- Jilin Cancer Hospital
-
-
Sichuan
-
Chengdu、Sichuan、中国、610049
- Sichuan Cancer Hospital
-
-
-
-
-
Montreal、加拿大、H4A 3J2
- McGill University Health Centre
-
-
-
-
-
Budapest、匈牙利、1083
- Semmelweis University Department of Pulmonology
-
Farkasgyepű、匈牙利、8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
-
KecskemĂŠt、匈牙利、6000
- Bkmk Hospital
-
Székesfehérvár、匈牙利、8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
-
Törökbálint、匈牙利、2045
- Pulmonology Hospital Torokbalint
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-
-
-
-
Kaohsiung City、台湾、824
- E-Da Hospital
-
Kaohsiung City、台湾、833
- Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
-
Taichung、台湾、40705
- Taichung Veterans General Hospital
-
Taichung、台湾、40201
- Chung Shan Medical University Hospital
-
Tainan、台湾、704
- National Cheng Kung University Hospital Nckuh
-
Taipei、台湾、100
- National Taiwan University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital
-
Taipei、台湾、112
- Koo Foundation Sun Yat-Sen Cancer Center
-
Taoyuan、台湾、333
- Chang Gung Memorial Hospital LinKou
-
-
-
-
-
Adana、土耳其（türkiye）、1130
- Adana Acibadem Hospital
-
Antalya、土耳其（türkiye）、7070
- Akdeniz University Hospital
-
Bornova-İzmir、土耳其（türkiye）、35100
- Ege University
-
Istanbul、土耳其（türkiye）、34772
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Seyhan /Adana、土耳其（türkiye）、1140
- Medical Park Seyhan Hospital
-
Çankaya、土耳其（türkiye）、06520
- Memorial Ankara Hospital Ankara
-
-
-
-
-
Cuauhtémoc、墨西哥、06100
- Cryptex Investigacion Clinica Sa de Cv
-
Guadalajara、墨西哥、44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
-
Monterrey、墨西哥、64460
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
-
Oaxaca City、墨西哥、68020
- Centro de Investigacion Clinica de Oaxaca (CICLO)
-
San Luis Potosí City、墨西哥、78209
- Oncologico Potosino
-
-
-
-
-
Klagenfurt、奥地利
- Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
-
Vienna、奥地利、1090
- Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
-
-
-
-
-
Caxias do Sul、巴西、95020-972
- Instituto de Pesquisas em Saúde - IPS
-
Curitiba、巴西、81520-060
- Hospital Erasto Gaertner
-
Ijuí、巴西、98700-000
- Oncosite - Centro de Pesquisa Clinica Oncologia
-
Itajaí、巴西、88301-220
- Clínica de Neoplasias Litoral
-
Pelotas、巴西、96020-080
- UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
-
Porto Alegre、巴西、90050-170
- Santa Casa de Misericordia de Porto Alegre
-
Rio de Janeiro、巴西、20231-050
- Instituto Nacional de Câncer - INCA
-
Santo André、巴西、09060-870
- Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
-
São Paulo、巴西、01236-030
- Instituto de Ensino e Pesquisas Sao Lucas
-
Taubaté、巴西
- Instituto do Cancer Brasil - Unidade Taubate
-
-
-
-
-
Athens、希腊、11527
- Sotiria General Hosptial of Chest Diseases
-
Ioannina、希腊、45500
- University Hospital of Ioannina Uhi
-
Neo Faliro、希腊、18547
- Metropolitan Hospital
-
Piraeus、希腊、18547
- Metropolitan Hospital
-
Thessaloniki、希腊、54622
- Bioclinic Thessaloniki
-
Thessaloniki、希腊、55236
- St. Luke's Hospital
-
-
Athens
-
Neo Faliro、Athens、希腊、14564
- Metropolitan Hospital
-
-
-
-
-
Berlin、德国、13125
- Evangelische Lungenklinik Berlin
-
Esslingen am Neckar、德国、73730
- Klinikum Esslingen GmbH
-
Großhansdorf、德国、22927
- LungenClinic Grosshansdorf
-
München、德国、80336
- Klinikum der Universitaet Muenchen
-
-
-
-
-
Bari、意大利、70124
- IRCCS Istituto Oncologico Giovanni Paolo II
-
Chieti、意大利、66100
- UOC Oncologia
-
Lucca、意大利、55100
- Ospedale San Luca
-
Milan、意大利、20132
- IRCCS Ospedale San Raffaele
-
Milan、意大利、20141
- Irccs Istituto Europeo Di Oncologia
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Naples、意大利、80131
- Azienda Ospedaliera dei Colli
-
Perugia、意大利、06132
- A.O. Perugia Santa Maria della Misericordia
-
Rome、意大利、133
- Policlinico Tor Vergata
-
Rome、意大利、144
- Ifo Regina Elena
-
Varese、意大利、21100
- Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
-
-
-
-
-
Kofu、日本
- Yamanashi Prefectural Central Hospital
-
Kyoto、日本、602-8566
- University Hospital Kyoto Prefectural University of Medicine
-
Osaka、日本、560-8552
- Osaka Toneyama Medical Center
-
Sapporo、日本、006-8555
- Teine Keijinkai Hospital
-
-
Aomori
-
Aomori、Aomori、日本、030-8553
- Aomori Prefectural Central Hospital
-
-
Chiba
-
Kashiwa-shi、Chiba、日本、277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama、Ehime、日本、791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka、Fukuoka、日本、812-8582
- Kyushu University Hospital
-
Fukuoka、Fukuoka、日本、811-1395
- National Hospital Organization Kyushu Cancer Center
-
Kurume-shi、Fukuoka、日本、830-0011
- Kurume University Hospital
-
-
Ishikawa-ken
-
Kanazawa、Ishikawa-ken、日本、920-8641
- Kanazawa University Hospital
-
-
Kanagawa
-
Yokohama、Kanagawa、日本、241-8515
- Kanagawa Cancer Center
-
-
Kumamoto
-
Kumamoto、Kumamoto、日本、861- 4193
- Saiseikai Kumamoto Hospital
-
-
Mie-ken
-
Matsusaka-shi、Mie-ken、日本、515-8544
- Matsusaka Municipal Hospital
-
-
Miyagi
-
Sendai、Miyagi、日本、980-0873
- Sendai Kousei Hospital
-
-
Niigata
-
Niigata、Niigata、日本、961-8566
- Niigata Cancer Center Hospital
-
-
Osaka
-
Hirakata-shi、Osaka、日本、573-1191
- Kansai Medical University Hospital
-
Osaka、Osaka、日本、541-8567
- Osaka International Cancer Institute
-
Sakai-shi、Osaka、日本、591-8555
- NHO Kinki-Chuo Chest Medical Center
-
-
Tochigi
-
Shimotsuga-gun、Tochigi、日本、321-0293
- Dokkyo Medical University Hospital
-
-
Tokyo
-
Bunkyo-ku、Tokyo、日本、113-8431
- Juntendo University Hospital
-
Bunkyō-Ku、Tokyo、日本、113-8677
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
-
-
Toyko
-
Kōtoku、Toyko、日本、135-8550
- The Cancer Institute Hospital of JFCR
-
Ōta-ku、Toyko、日本、143-8541
- Toho University Omori Medical Center
-
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Yamaguchi
-
Iwakuni-shi、Yamaguchi、日本、740-8510
- NHO Iwakuni Clinical Center
-
Ube-shi、Yamaguchi、日本、755-0241
- Yamaguchi-Ube Medical Center
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-
-
-
-
Santiago、智利、7500000
- Oncovida
-
Santiago、智利、7500921
- Fundación Arturo Pérez López
-
Santiago、智利、7501010
- Orlandi Oncología
-
Viña del Mar、智利、254-0488
- Centro de Investigaciones Clinicas Vina Del Mar
-
-
Santiago Metropolitan
-
Santiago、Santiago Metropolitan、智利、7500653
- Centro de Estudios Clínicos SAGA
-
-
-
-
-
Aalst、比利时、9300
- Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
-
Charleroi、比利时、6000
- Grand Hopital de Charleroi - Hopital Saint Joseph
-
Ghent、比利时、9000
- Az Maria Middelares - Campus Maria Middelares
-
Sint-Niklaas、比利时、9100
- AZ Nikolaas
-
-
-
-
-
Avignon、法国、84000
- Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
-
Bordeaux、法国、33076
- Institut Bergonie
-
Bordeaux、法国、33075
- Bordeaux University Hospital - Hopital Saint Andre
-
Lille、法国、59000
- Centre Hospitalier Universitaire de Lille
-
Lyon、法国、69008
- Centre Leon Berard
-
Marseille、法国、13273
- Institut Paoli-Calmettes
-
Marseille、法国、13015
- APHM - Hopital Nord
-
Montpellier、法国、34295
- Centre Hospitalier Universitaire de Montpellier
-
Nantes、法国、44093
- CHU de Nantes
-
Nantes、法国、44277
- Hopital prive du Confluent
-
Paris、法国、75970
- AP-HP - Hopital Tenon
-
Poitiers、法国、86000
- CHU de Poitier Pole Regional de Cancerologie
-
Suresnes、法国、92150
- Hopital FOCH
-
-
-
-
-
Bialystok、波兰、15-450
- II Klinika Chorob Pluc I Gruzlicy
-
Lublin、波兰、20-064
- MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
-
-
Iodzkie
-
Lodz、Iodzkie、波兰、93-338
- Instytut Centrum Zdrowia Matki Polki
-
-
Pomeranian Voivodeship
-
Gdynia、Pomeranian Voivodeship、波兰、81-519
- Szpitale Pomorskie Sp. z o.o.
-
-
West Pomeranian Voivodeship
-
Szczecin、West Pomeranian Voivodeship、波兰、70-784
- Dom Lekarski SA
-
-
-
-
-
Bangkok、泰国、10700
- Siriraj Hospital
-
Bangkok、泰国、10330
- Faculty of Medicine Chulalongkorn University
-
-
Changwat Khon Kaen
-
Muaeng、Changwat Khon Kaen、泰国、40002
- Srinagarind Hospital
-
-
Changwat Songkhla
-
Hat Yai、Changwat Songkhla、泰国、90110
- Prince of Songkla University PSU - Faculty of Medicine
-
-
-
-
-
Camperdown、澳大利亚、2050
- Chris Obrien Lifehouse
-
Woodville South、澳大利亚、5011
- The Queen Elizabeth Hospital
-
-
Victoria
-
Heidelberg、Victoria、澳大利亚、3084
- Austin Hospital
-
Mount Waverley、Victoria、澳大利亚、3149
- Peninsula and South Eastern Haematology and Oncology Group
-
-
-
-
-
Baden、瑞士、5404
- Kantonsspital Baden
-
Basel、瑞士、4031
- University Hospital Basel
-
Liestal、瑞士、A4410
- Kantonsspital Baselland
-
Sankt Gallen、瑞士
- Kantonsspital St. Gallen
-
-
-
-
-
Craiova、罗马尼亚、200094
- Onco Clinic Consult SA
-
Craiova、罗马尼亚、200542
- Centrul de Oncologie Sf Nectarie S.R.L.
-
Suceava、罗马尼亚、720214
- Sc Sigmedical Services Srl
-
Timișoara、罗马尼亚、300166
- Oncocenter-Oncologie Clinica SRL
-
Timișoara、罗马尼亚、300239
- SC Oncomed SRL
-
-
-
-
Arizona
-
Chandler、Arizona、美国、85224
- Ironwood Cancer and Research Center
-
-
California
-
Los Angeles、California、美国、90095
- UCLA HemOnc - Clinical Research Unit
-
Santa Barbara、California、美国、93105
- Ridley-Tree Cancer Center
-
Whittier、California、美国、90603
- The Oncology Institute of Hope and Innovation
-
Whittier、California、美国、90602
- PIH Health Whittier Hospital
-
-
Colorado
-
Colorado Springs、Colorado、美国、80909
- Uch-Mhs D/B/A Memorial Health System
-
-
Maryland
-
Baltimore、Maryland、美国、21205
- Johns Hopkins University
-
Bethesda、Maryland、美国、20817
- American Oncology Partners of Maryland
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
-
Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
-
Foxborough、Massachusetts、美国、02035
- Dana Farber Cancer Institute - Foxborough
-
South Weymouth、Massachusetts、美国、02190
- DFCI - South Shore Hospital
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03766
- Dartmouth Hitchcock Medical Center
-
-
New Jersey
-
East Brunswick、New Jersey、美国、08816
- Astera Cancer Care
-
Freehold、New Jersey、美国、07728
- Regional Cancer Care Associates LLC
-
New Brunswick、New Jersey、美国、08901
- Cooperman Barnabas Medical Center
-
Paramus、New Jersey、美国、07652
- The Valley Hospital
-
-
New York
-
The Bronx、New York、美国、10461
- Montefiore Medical Center
-
-
Texas
-
Irving、Texas、美国、75063
- Arizona Oncology NAHOA
-
Irving、Texas、美国、75063
- Cancer Care Center of Brevard
-
Irving、Texas、美国、75063
- Illinois Cancer Specialists
-
Irving、Texas、美国、75063
- Maryland Oncology Hematology
-
Irving、Texas、美国、75063
- Southern Cancer Center
-
Irving、Texas、美国、75063
- Texas Oncology - Northeast Texas
-
Irving、Texas、美国、75063
- Texas Oncology Gulf Coast
-
Irving、Texas、美国、75063
- Texas Oncology McAllen
-
San Antonio、Texas、美国、78229
- University of Texas Health Science Center San Antonio
-
-
Utah
-
Salt Lake City、Utah、美国、84106
- Utah Cancer Specialists
-
-
Washington
-
Lacey、Washington、美国、98503
- Providence Regional Cancer System
-
Seattle、Washington、美国、98108
- VA Puget Sound Health Care System - VAPSHCS
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin
-
-
-
-
-
Birmingham、英国、B9 5SS
- Birmingham Heartlands Hospital
-
Nottingham、英国、NG5 1PB
- Nottingham University Hospitals
-
-
-
-
-
's-Hertogenbosch、荷兰、5223 GZ
- Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
-
Amsterdam、荷兰、1081 HZ
- Amsterdam Umc, Location Vumc
-
Leiden、荷兰、2333 ZA
- Leiden University Medical Center
-
-
Gelderland
-
Arnhem、Gelderland、荷兰、6815 AD
- Rijnstate Ziekenhuis
-
-
-
-
-
Lisbon、葡萄牙、1400-038
- Centro Clinico Champalimau
-
Porto、葡萄牙、4100-180
- Hospital CUF Porto
-
Porto、葡萄牙、4099-001
- Centro Hospitalar e Universitário do Porto
-
Porto、葡萄牙、4200-072
- Instituto Portuguas de Oncologia do Porto Francisco Gentil
-
Porto、葡萄牙、4200-319
- Centro Hospitalar Universitário de São João
-
-
-
-
-
Barcelona、西班牙、08036
- Hospital Clinic i Provincial de Barcelona
-
Barcelona、西班牙、8035
- Hospital Universitari Vall D'Hebron
-
Lleida、西班牙、25198
- Hospital Universitario Arnau de Vilanova - Lleida
-
Madrid、西班牙、28040
- Hospital Clinico San Carlos
-
Madrid、西班牙、28007
- Hospital General Universitario Gregorio Marañon
-
Madrid、西班牙、28040
- Hospital Universitario Fundacion Jimenez Diaz
-
Málaga、西班牙、29010
- Hospital Regional Universitario Malaga
-
Ourense、西班牙、32005
- CHUO
-
Seville、西班牙、41009
- Hospital Universitario Virgen Macarena
-
Seville、西班牙、41014
- Hospital Universitario de Valme
-
Valencia、西班牙、46026
- Hospital Universitari i Politècnic La Fe
-
Zaragoza、西班牙、50009
- Hospital Universitario Miguel Servet
-
-
-
-
-
Buenos Aires、阿根廷
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
-
Ciudad Autonoma de Buenos Aire、阿根廷、1125
- Fundacion CENIT para la investigación en Neurociencias
-
Mar del Plata、阿根廷、B7602CBM
- Hospital Privado de la Comunidad
-
Pergamino、阿根廷、2700
- Centro de Investigación Pergamino S. A.
-
Rosario、阿根廷、S2001
- Sanatorio Parque
-
Rosario、阿根廷、S2000
- Instituto de Oncología de Rosario
-
Rosario、阿根廷、S2002
- Sanatorio Británico de Rosario
-
San Juan、阿根廷、5400
- CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
-
Viedma、阿根廷、8500
- Clinica Viedma SA
-
-
-
-
-
Daegu、韩国、42119
- Kyungpook National University Chilgok Hospital
-
Goyang-si、韩国、10408
- National Cancer Center
-
Seoul、韩国、6351
- Samsung Medical Center
-
Seoul、韩国、6591
- The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
-
Songpa-gu、韩国、5505
- Asan Medical Center
-
-
Gyeonggi-do
-
Seongnam-si、Gyeonggi-do、韩国、13620
- Seoul National University Bundang Hospital
-
-
Gyeongsangnam-do
-
Jinju、Gyeongsangnam-do、韩国、52727
- Gyeongsang National University Hospital
-
-
North Chungcheong
-
Cheongju-si、North Chungcheong、韩国、28644
- Chungbuk National University Hospital
-
-
-
-
-
Hong Kong、香港
- Queen Elizabeth Hospital
-
Hong Kong、香港、99999
- Prince of Wales Hospital / The Chinese University of Hong Kong 99999
-
Pok Fu Lam、香港、999077
- Queen Mary Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.
-
Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
-
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
-
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.
-
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.
-
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).
-
Has an adequate treatment washout period before Cycle 1 Day 1.
-
Measurable disease based on local imaging assessment using RECIST Version 1.1.
-
Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
-
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
-
Has a life expectancy of at least 3 months.
-
Adequate bone marrow function within 7 days before randomization.
Exclusion Criteria:
-
Has received prior systemic treatment for advanced or metastatic NSCLC.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
其他名称：
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
其他名称：
|
|
有源比较器：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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
大体时间：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+)
大体时间：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
大体时间：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
大体时间：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+)
大体时间：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
大体时间：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+
大体时间：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+
大体时间：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+
大体时间：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+
大体时间：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+
大体时间：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+
大体时间：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+
大体时间：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
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间：Baseline and up to 72 months
|
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. |
Baseline and up to 72 months
|
合作者和调查者
调查人员
- 研究主任：Global Clinical Leader、Daiichi Sankyo
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- DS1062-A-U304
- 2021-002555-10 (EudraCT编号)
- KEYNOTE-C73 (其他标识符：Merck)
- MK3475-C73 (其他标识符：Merck)
- 2023-507933-12-00 (克蒂斯)
- 2023 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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/
IPD 共享时间框架
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.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.