実行可能なゲノム変化を伴わない進行性または転移性 NSCLC 患者の第一選択治療における Dato-DXd とペムブロリズマブとペムブロリズマブ単独の比較に関する研究 (TROPION-Lung08)
進行性または転移性 PD-L1 高値 (TPS ≥50%) の未治療の非小細胞肺がん患者を対象とした、Dato-DXd とペムブロリズマブの併用 vs ペムブロリズマブ単独の無作為化非盲検第 3 相試験 (TROPION) -Lung08)
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).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Arizona
-
Chandler、Arizona、アメリカ、85224
- Ironwood Cancer and Research Center
-
-
California
-
Los Angeles、California、アメリカ、90095
- UCLA HemOnc - Clinical Research Unit
-
Santa Barbara、California、アメリカ、93105
- Ridley-Tree Cancer Center
-
Whittier、California、アメリカ、90603
- The Oncology Institute of Hope and Innovation
-
Whittier、California、アメリカ、90602
- PIH Health Whittier Hospital
-
-
Colorado
-
Colorado Springs、Colorado、アメリカ、80909
- Uch-Mhs D/B/A Memorial Health System
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21205
- Johns Hopkins University
-
Bethesda、Maryland、アメリカ、20817
- American Oncology Partners of Maryland
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center
-
Boston、Massachusetts、アメリカ、02115
- Dana-Farber Cancer Institute
-
Foxborough、Massachusetts、アメリカ、02035
- Dana Farber Cancer Institute - Foxborough
-
South Weymouth、Massachusetts、アメリカ、02190
- DFCI - South Shore Hospital
-
-
New Hampshire
-
Lebanon、New Hampshire、アメリカ、03766
- Dartmouth Hitchcock Medical Center
-
-
New Jersey
-
East Brunswick、New Jersey、アメリカ、08816
- Astera Cancer Care
-
Freehold、New Jersey、アメリカ、07728
- Regional Cancer Care Associates LLC
-
New Brunswick、New Jersey、アメリカ、08901
- Cooperman Barnabas Medical Center
-
Paramus、New Jersey、アメリカ、07652
- The Valley Hospital
-
-
New York
-
The Bronx、New York、アメリカ、10461
- Montefiore Medical Center
-
-
Texas
-
Irving、Texas、アメリカ、75063
- Arizona Oncology NAHOA
-
Irving、Texas、アメリカ、75063
- Cancer Care Center of Brevard
-
Irving、Texas、アメリカ、75063
- Illinois Cancer Specialists
-
Irving、Texas、アメリカ、75063
- Maryland Oncology Hematology
-
Irving、Texas、アメリカ、75063
- Southern Cancer Center
-
Irving、Texas、アメリカ、75063
- Texas Oncology - Northeast Texas
-
Irving、Texas、アメリカ、75063
- Texas Oncology Gulf Coast
-
Irving、Texas、アメリカ、75063
- Texas Oncology McAllen
-
San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center San Antonio
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84106
- Utah Cancer Specialists
-
-
Washington
-
Lacey、Washington、アメリカ、98503
- Providence Regional Cancer System
-
Seattle、Washington、アメリカ、98108
- VA Puget Sound Health Care System - VAPSHCS
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin
-
-
-
-
-
Buenos Aires、アルゼンチン
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
-
Ciudad Autonoma de Buenos Aire、アルゼンチン、1125
- Fundacion CENIT para la investigación en Neurociencias
-
Mar del Plata、アルゼンチン、B7602CBM
- Hospital Privado de la Comunidad
-
Pergamino、アルゼンチン、2700
- Centro de Investigación Pergamino S. A.
-
Rosario、アルゼンチン、S2001
- Sanatorio Parque
-
Rosario、アルゼンチン、S2000
- Instituto de Oncología de Rosario
-
Rosario、アルゼンチン、S2002
- Sanatorio Británico de Rosario
-
San Juan、アルゼンチン、5400
- CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
-
Viedma、アルゼンチン、8500
- Clinica Viedma SA
-
-
-
-
-
Birmingham、イギリス、B9 5SS
- Birmingham Heartlands Hospital
-
Nottingham、イギリス、NG5 1PB
- Nottingham University Hospitals
-
-
-
-
-
Bari、イタリア、70124
- IRCCS Istituto Oncologico Giovanni Paolo II
-
Chieti、イタリア、66100
- UOC Oncologia
-
Lucca、イタリア、55100
- Ospedale San Luca
-
Milan、イタリア、20132
- IRCCS Ospedale San Raffaele
-
Milan、イタリア、20141
- Irccs Istituto Europeo Di Oncologia
-
Naples、イタリア、80131
- Azienda Ospedaliera dei Colli
-
Perugia、イタリア、06132
- A.O. Perugia Santa Maria della Misericordia
-
Rome、イタリア、133
- Policlinico Tor Vergata
-
Rome、イタリア、144
- Ifo Regina Elena
-
Varese、イタリア、21100
- Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
-
-
-
-
-
's-Hertogenbosch、オランダ、5223 GZ
- Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
-
Amsterdam、オランダ、1081 HZ
- Amsterdam Umc, Location Vumc
-
Leiden、オランダ、2333 ZA
- Leiden University Medical Center
-
-
Gelderland
-
Arnhem、Gelderland、オランダ、6815 AD
- Rijnstate Ziekenhuis
-
-
-
-
-
Camperdown、オーストラリア、2050
- Chris Obrien Lifehouse
-
Woodville South、オーストラリア、5011
- The Queen Elizabeth Hospital
-
-
Victoria
-
Heidelberg、Victoria、オーストラリア、3084
- Austin Hospital
-
Mount Waverley、Victoria、オーストラリア、3149
- Peninsula and South Eastern Haematology and Oncology Group
-
-
-
-
-
Klagenfurt、オーストリア
- Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
-
Vienna、オーストリア、1090
- Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
-
-
-
-
-
Montreal、カナダ、H4A 3J2
- McGill University Health Centre
-
-
-
-
-
Athens、ギリシャ、11527
- Sotiria General Hosptial of Chest Diseases
-
Ioannina、ギリシャ、45500
- University Hospital of Ioannina Uhi
-
Neo Faliro、ギリシャ、18547
- Metropolitan Hospital
-
Piraeus、ギリシャ、18547
- Metropolitan Hospital
-
Thessaloniki、ギリシャ、54622
- Bioclinic Thessaloniki
-
Thessaloniki、ギリシャ、55236
- St. Luke's Hospital
-
-
Athens
-
Neo Faliro、Athens、ギリシャ、14564
- Metropolitan Hospital
-
-
-
-
-
Baden、スイス、5404
- Kantonsspital Baden
-
Basel、スイス、4031
- University Hospital Basel
-
Liestal、スイス、A4410
- Kantonsspital Baselland
-
Sankt Gallen、スイス
- Kantonsspital St. Gallen
-
-
-
-
-
Barcelona、スペイン、08036
- Hospital Clinic i Provincial de Barcelona
-
Barcelona、スペイン、8035
- Hospital Universitari Vall D'Hebron
-
Lleida、スペイン、25198
- Hospital Universitario Arnau de Vilanova - Lleida
-
Madrid、スペイン、28040
- Hospital Clinico San Carlos
-
Madrid、スペイン、28007
- Hospital General Universitario Gregorio Marañon
-
Madrid、スペイン、28040
- Hospital Universitario Fundacion Jimenez Diaz
-
Málaga、スペイン、29010
- Hospital Regional Universitario Malaga
-
Ourense、スペイン、32005
- CHUO
-
Seville、スペイン、41009
- Hospital Universitario Virgen Macarena
-
Seville、スペイン、41014
- Hospital Universitario de Valme
-
Valencia、スペイン、46026
- Hospital Universitari i Politècnic La Fe
-
Zaragoza、スペイン、50009
- Hospital Universitario Miguel Servet
-
-
-
-
-
Bangkok、タイ、10700
- Siriraj Hospital
-
Bangkok、タイ、10330
- Faculty of Medicine Chulalongkorn University
-
-
Changwat Khon Kaen
-
Muaeng、Changwat Khon Kaen、タイ、40002
- Srinagarind Hospital
-
-
Changwat Songkhla
-
Hat Yai、Changwat Songkhla、タイ、90110
- Prince of Songkla University PSU - Faculty of Medicine
-
-
-
-
-
Santiago、チリ、7500000
- Oncovida
-
Santiago、チリ、7500921
- Fundación Arturo Pérez López
-
Santiago、チリ、7501010
- Orlandi Oncología
-
Viña del Mar、チリ、254-0488
- Centro de Investigaciones Clinicas Vina Del Mar
-
-
Santiago Metropolitan
-
Santiago、Santiago Metropolitan、チリ、7500653
- Centro de Estudios Clínicos SAGA
-
-
-
-
-
Adana、トルコ（Türkiye）、1130
- Adana Acibadem Hospital
-
Antalya、トルコ（Türkiye）、7070
- Akdeniz University Hospital
-
Bornova-İzmir、トルコ（Türkiye）、35100
- Ege University
-
Istanbul、トルコ（Türkiye）、34772
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Seyhan /Adana、トルコ（Türkiye）、1140
- Medical Park Seyhan Hospital
-
Çankaya、トルコ（Türkiye）、06520
- Memorial Ankara Hospital Ankara
-
-
-
-
-
Berlin、ドイツ、13125
- Evangelische Lungenklinik Berlin
-
Esslingen am Neckar、ドイツ、73730
- Klinikum Esslingen GmbH
-
Großhansdorf、ドイツ、22927
- LungenClinic Grosshansdorf
-
München、ドイツ、80336
- Klinikum der Universitaet Muenchen
-
-
-
-
-
Budapest、ハンガリー、1083
- Semmelweis University Department of Pulmonology
-
Farkasgyepű、ハンガリー、8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
-
KecskemĂŠt、ハンガリー、6000
- Bkmk Hospital
-
Székesfehérvár、ハンガリー、8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
-
Törökbálint、ハンガリー、2045
- Pulmonology Hospital Torokbalint
-
-
-
-
-
Avignon、フランス、84000
- Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
-
Bordeaux、フランス、33076
- Institut Bergonie
-
Bordeaux、フランス、33075
- Bordeaux University Hospital - Hopital Saint Andre
-
Lille、フランス、59000
- Centre Hospitalier Universitaire de Lille
-
Lyon、フランス、69008
- Centre Leon Berard
-
Marseille、フランス、13273
- Institut Paoli-Calmettes
-
Marseille、フランス、13015
- APHM - Hopital Nord
-
Montpellier、フランス、34295
- Centre Hospitalier Universitaire de Montpellier
-
Nantes、フランス、44093
- CHU de Nantes
-
Nantes、フランス、44277
- Hopital prive du Confluent
-
Paris、フランス、75970
- AP-HP - Hopital Tenon
-
Poitiers、フランス、86000
- CHU de Poitier Pole Regional de Cancerologie
-
Suresnes、フランス、92150
- Hopital FOCH
-
-
-
-
-
Caxias do Sul、ブラジル、95020-972
- Instituto de Pesquisas em Saúde - IPS
-
Curitiba、ブラジル、81520-060
- Hospital Erasto Gaertner
-
Ijuí、ブラジル、98700-000
- Oncosite - Centro de Pesquisa Clinica Oncologia
-
Itajaí、ブラジル、88301-220
- Clínica de Neoplasias Litoral
-
Pelotas、ブラジル、96020-080
- UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
-
Porto Alegre、ブラジル、90050-170
- Santa Casa de Misericordia de Porto Alegre
-
Rio de Janeiro、ブラジル、20231-050
- Instituto Nacional de Câncer - INCA
-
Santo André、ブラジル、09060-870
- Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
-
São Paulo、ブラジル、01236-030
- Instituto de Ensino e Pesquisas Sao Lucas
-
Taubaté、ブラジル
- Instituto do Cancer Brasil - Unidade Taubate
-
-
-
-
-
Aalst、ベルギー、9300
- Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
-
Charleroi、ベルギー、6000
- Grand Hopital de Charleroi - Hopital Saint Joseph
-
Ghent、ベルギー、9000
- Az Maria Middelares - Campus Maria Middelares
-
Sint-Niklaas、ベルギー、9100
- AZ Nikolaas
-
-
-
-
-
Lisbon、ポルトガル、1400-038
- Centro Clinico Champalimau
-
Porto、ポルトガル、4100-180
- Hospital CUF Porto
-
Porto、ポルトガル、4099-001
- Centro Hospitalar e Universitário do Porto
-
Porto、ポルトガル、4200-072
- Instituto Portuguas de Oncologia do Porto Francisco Gentil
-
Porto、ポルトガル、4200-319
- Centro Hospitalar Universitário de São João
-
-
-
-
-
Bialystok、ポーランド、15-450
- II Klinika Chorob Pluc I Gruzlicy
-
Lublin、ポーランド、20-064
- MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
-
-
Iodzkie
-
Lodz、Iodzkie、ポーランド、93-338
- Instytut Centrum Zdrowia Matki Polki
-
-
Pomeranian Voivodeship
-
Gdynia、Pomeranian Voivodeship、ポーランド、81-519
- Szpitale Pomorskie Sp. z o.o.
-
-
West Pomeranian Voivodeship
-
Szczecin、West Pomeranian Voivodeship、ポーランド、70-784
- Dom Lekarski SA
-
-
-
-
-
Cuauhtémoc、メキシコ、06100
- Cryptex Investigacion Clinica Sa de Cv
-
Guadalajara、メキシコ、44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
-
Monterrey、メキシコ、64460
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
-
Oaxaca City、メキシコ、68020
- Centro de Investigacion Clinica de Oaxaca (CICLO)
-
San Luis Potosí City、メキシコ、78209
- Oncologico Potosino
-
-
-
-
-
Craiova、ルーマニア、200094
- Onco Clinic Consult SA
-
Craiova、ルーマニア、200542
- Centrul de Oncologie Sf Nectarie S.R.L.
-
Suceava、ルーマニア、720214
- Sc Sigmedical Services Srl
-
Timișoara、ルーマニア、300166
- Oncocenter-Oncologie Clinica SRL
-
Timișoara、ルーマニア、300239
- SC Oncomed SRL
-
-
-
-
-
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
-
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
-
Linyi、中国、276000
- Linyi Cancer Hospital
-
Nanchang、中国、330006
- The First Affiliated Hospital of Nanchang University
-
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
-
-
-
-
-
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
-
-
-
-
-
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
-
-
Yamaguchi
-
Iwakuni-shi、Yamaguchi、日本、740-8510
- NHO Iwakuni Clinical Center
-
Ube-shi、Yamaguchi、日本、755-0241
- Yamaguchi-Ube Medical Center
-
-
-
-
-
Daegu、韓国、42119
- Kyungpook National University Chilgok Hospital
-
Goyang-si、韓国、10408
- National Cancer Center
-
Seoul、韓国、6351
- Samsung Medical Center
-
Seoul、韓国、6591
- The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
-
Songpa-gu、韓国、5505
- Asan Medical Center
-
-
Gyeonggi-do
-
Seongnam-si、Gyeonggi-do、韓国、13620
- Seoul National University Bundang Hospital
-
-
Gyeongsangnam-do
-
Jinju、Gyeongsangnam-do、韓国、52727
- Gyeongsang National University Hospital
-
-
North Chungcheong
-
Cheongju-si、North Chungcheong、韓国、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
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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.
他の名前：
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
時間枠：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+)
時間枠：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
時間枠：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
時間枠：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+)
時間枠：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
時間枠：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+
時間枠：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+
時間枠：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+
時間枠：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+
時間枠：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+
時間枠：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+
時間枠：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+
時間枠：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
時間枠：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
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：Baseline and up to 72 months
|
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. |
Baseline and up to 72 months
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- スタディディレクター：Global Clinical Leader、Daiichi Sankyo
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- DS1062-A-U304
- 2021-002555-10 (EudraCT番号)
- KEYNOTE-C73 (その他の識別子：Merck)
- MK3475-C73 (その他の識別子：Merck)
- 2023-507933-12-00 (Ctis)
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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