실행 가능한 게놈 변경이 없는 진행성 또는 전이성 NSCLC 피험자의 1차 치료에서 Dato-DXd 플러스 펨브롤리주맙 대 펨브롤리주맙 단독 연구 (TROPION-Lung08)
실행 가능한 게놈 변경이 없는 진행성 또는 전이성 PD-L1 높음(TPS ≥50%) 비소세포폐암(TROPION -폐08)
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).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Athens, 그리스, 11527
- Sotiria General Hosptial of Chest Diseases
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Ioannina, 그리스, 45500
- University Hospital of Ioannina Uhi
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Neo Faliro, 그리스, 18547
- Metropolitan Hospital
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Piraeus, 그리스, 18547
- Metropolitan Hospital
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Thessaloniki, 그리스, 54622
- Bioclinic Thessaloniki
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Thessaloniki, 그리스, 55236
- St. Luke's Hospital
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Athens
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Neo Faliro, Athens, 그리스, 14564
- Metropolitan Hospital
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's-Hertogenbosch, 네덜란드, 5223 GZ
- Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
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Amsterdam, 네덜란드, 1081 HZ
- Amsterdam Umc, Location Vumc
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Leiden, 네덜란드, 2333 ZA
- Leiden University Medical Center
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Gelderland
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Arnhem, Gelderland, 네덜란드, 6815 AD
- Rijnstate Ziekenhuis
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Kaohsiung City, 대만, 824
- E-Da Hospital
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Kaohsiung City, 대만, 833
- Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Taichung, 대만, 40201
- Chung Shan Medical University Hospital
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Tainan, 대만, 704
- National Cheng Kung University Hospital Nckuh
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Taipei, 대만, 100
- National Taiwan University Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taipei, 대만, 112
- Koo Foundation Sun Yat-Sen Cancer Center
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Taoyuan, 대만, 333
- Chang Gung Memorial Hospital LinKou
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Daegu, 대한민국, 42119
- Kyungpook National University Chilgok Hospital
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Goyang-si, 대한민국, 10408
- National Cancer Center
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Seoul, 대한민국, 6351
- Samsung Medical Center
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Seoul, 대한민국, 6591
- The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
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Songpa-gu, 대한민국, 5505
- Asan Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
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Gyeongsangnam-do
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Jinju, Gyeongsangnam-do, 대한민국, 52727
- Gyeongsang National University Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, 대한민국, 28644
- Chungbuk National University Hospital
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Berlin, 독일, 13125
- Evangelische Lungenklinik Berlin
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Esslingen am Neckar, 독일, 73730
- Klinikum Esslingen GmbH
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Großhansdorf, 독일, 22927
- LungenClinic Grosshansdorf
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München, 독일, 80336
- Klinikum der Universitaet Muenchen
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Craiova, 루마니아, 200094
- Onco Clinic Consult SA
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Craiova, 루마니아, 200542
- Centrul de Oncologie Sf Nectarie S.R.L.
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Suceava, 루마니아, 720214
- Sc Sigmedical Services Srl
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Timișoara, 루마니아, 300166
- Oncocenter-Oncologie Clinica SRL
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Timișoara, 루마니아, 300239
- SC Oncomed SRL
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Cuauhtémoc, 멕시코, 06100
- Cryptex Investigacion Clinica Sa de Cv
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Guadalajara, 멕시코, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Monterrey, 멕시코, 64460
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
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Oaxaca City, 멕시코, 68020
- Centro de Investigacion Clinica de Oaxaca (CICLO)
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San Luis Potosí City, 멕시코, 78209
- Oncologico Potosino
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Arizona
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Chandler, Arizona, 미국, 85224
- Ironwood Cancer and Research Center
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California
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Los Angeles, California, 미국, 90095
- UCLA HemOnc - Clinical Research Unit
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Santa Barbara, California, 미국, 93105
- Ridley-Tree Cancer Center
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Whittier, California, 미국, 90603
- The Oncology Institute of Hope and Innovation
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Whittier, California, 미국, 90602
- PIH Health Whittier Hospital
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Colorado
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Colorado Springs, Colorado, 미국, 80909
- Uch-Mhs D/B/A Memorial Health System
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Maryland
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins University
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Bethesda, Maryland, 미국, 20817
- American Oncology Partners of Maryland
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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Foxborough, Massachusetts, 미국, 02035
- Dana Farber Cancer Institute - Foxborough
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South Weymouth, Massachusetts, 미국, 02190
- DFCI - South Shore Hospital
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New Hampshire
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Lebanon, New Hampshire, 미국, 03766
- Dartmouth Hitchcock Medical Center
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New Jersey
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East Brunswick, New Jersey, 미국, 08816
- Astera Cancer Care
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Freehold, New Jersey, 미국, 07728
- Regional Cancer Care Associates LLC
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New Brunswick, New Jersey, 미국, 08901
- Cooperman Barnabas Medical Center
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Paramus, New Jersey, 미국, 07652
- The Valley Hospital
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New York
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The Bronx, New York, 미국, 10461
- Montefiore Medical Center
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Texas
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Irving, Texas, 미국, 75063
- Arizona Oncology NAHOA
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Irving, Texas, 미국, 75063
- Cancer Care Center of Brevard
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Irving, Texas, 미국, 75063
- Illinois Cancer Specialists
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Irving, Texas, 미국, 75063
- Maryland Oncology Hematology
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Irving, Texas, 미국, 75063
- Southern Cancer Center
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Irving, Texas, 미국, 75063
- Texas Oncology - Northeast Texas
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Irving, Texas, 미국, 75063
- Texas Oncology Gulf Coast
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Irving, Texas, 미국, 75063
- Texas Oncology McAllen
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San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center San Antonio
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Utah
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Salt Lake City, Utah, 미국, 84106
- Utah Cancer Specialists
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Washington
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Lacey, Washington, 미국, 98503
- Providence Regional Cancer System
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Seattle, Washington, 미국, 98108
- VA Puget Sound Health Care System - VAPSHCS
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
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Aalst, 벨기에, 9300
- Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
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Charleroi, 벨기에, 6000
- Grand Hopital de Charleroi - Hopital Saint Joseph
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Ghent, 벨기에, 9000
- Az Maria Middelares - Campus Maria Middelares
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Sint-Niklaas, 벨기에, 9100
- AZ Nikolaas
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Caxias do Sul, 브라질, 95020-972
- Instituto de Pesquisas em Saúde - IPS
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Curitiba, 브라질, 81520-060
- Hospital Erasto Gaertner
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Ijuí, 브라질, 98700-000
- Oncosite - Centro de Pesquisa Clinica Oncologia
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Itajaí, 브라질, 88301-220
- Clínica de Neoplasias Litoral
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Pelotas, 브라질, 96020-080
- UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
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Porto Alegre, 브라질, 90050-170
- Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, 브라질, 20231-050
- Instituto Nacional de Câncer - INCA
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Santo André, 브라질, 09060-870
- Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
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São Paulo, 브라질, 01236-030
- Instituto de Ensino e Pesquisas Sao Lucas
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Taubaté, 브라질
- Instituto do Cancer Brasil - Unidade Taubate
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Baden, 스위스, 5404
- Kantonsspital Baden
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Basel, 스위스, 4031
- University Hospital Basel
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Liestal, 스위스, A4410
- Kantonsspital Baselland
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Sankt Gallen, 스위스
- Kantonsspital St. Gallen
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Barcelona, 스페인, 08036
- Hospital Clinic i Provincial de Barcelona
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Barcelona, 스페인, 8035
- Hospital Universitari Vall D'Hebron
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Lleida, 스페인, 25198
- Hospital Universitario Arnau de Vilanova - Lleida
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos
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Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, 스페인, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Málaga, 스페인, 29010
- Hospital Regional Universitario Malaga
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Ourense, 스페인, 32005
- CHUO
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Seville, 스페인, 41009
- Hospital Universitario Virgen Macarena
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Seville, 스페인, 41014
- Hospital Universitario de Valme
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Valencia, 스페인, 46026
- Hospital Universitari i Politècnic La Fe
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Zaragoza, 스페인, 50009
- Hospital Universitario Miguel Servet
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Buenos Aires, 아르헨티나
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
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Ciudad Autonoma de Buenos Aire, 아르헨티나, 1125
- Fundacion CENIT para la investigación en Neurociencias
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Mar del Plata, 아르헨티나, B7602CBM
- Hospital Privado de la Comunidad
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Pergamino, 아르헨티나, 2700
- Centro de Investigación Pergamino S. A.
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Rosario, 아르헨티나, S2001
- Sanatorio Parque
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Rosario, 아르헨티나, S2000
- Instituto de Oncología de Rosario
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Rosario, 아르헨티나, S2002
- Sanatorio Británico de Rosario
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San Juan, 아르헨티나, 5400
- CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
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Viedma, 아르헨티나, 8500
- Clinica Viedma SA
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Birmingham, 영국, B9 5SS
- Birmingham Heartlands Hospital
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Nottingham, 영국, NG5 1PB
- Nottingham University Hospitals
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Klagenfurt, 오스트리아
- Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
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Vienna, 오스트리아, 1090
- Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
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Bari, 이탈리아, 70124
- IRCCS Istituto Oncologico Giovanni Paolo II
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Chieti, 이탈리아, 66100
- UOC Oncologia
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Lucca, 이탈리아, 55100
- Ospedale San Luca
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Milan, 이탈리아, 20132
- IRCCS Ospedale San Raffaele
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Milan, 이탈리아, 20141
- Irccs Istituto Europeo Di Oncologia
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Naples, 이탈리아, 80131
- Azienda Ospedaliera dei Colli
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Perugia, 이탈리아, 06132
- A.O. Perugia Santa Maria della Misericordia
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Rome, 이탈리아, 133
- Policlinico Tor Vergata
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Rome, 이탈리아, 144
- Ifo Regina Elena
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Varese, 이탈리아, 21100
- Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
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Kofu, 일본
- Yamanashi Prefectural Central Hospital
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Kyoto, 일본, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Osaka, 일본, 560-8552
- Osaka Toneyama Medical Center
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Sapporo, 일본, 006-8555
- Teine Keijinkai Hospital
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Aomori
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Aomori, Aomori, 일본, 030-8553
- Aomori Prefectural Central Hospital
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Chiba
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Kashiwa-shi, Chiba, 일본, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, 일본, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, 일본, 812-8582
- Kyushu University Hospital
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Fukuoka, Fukuoka, 일본, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Kurume-shi, Fukuoka, 일본, 830-0011
- Kurume University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, 일본, 920-8641
- Kanazawa University Hospital
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Kanagawa
-
Yokohama, Kanagawa, 일본, 241-8515
- Kanagawa Cancer Center
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Kumamoto
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Kumamoto, Kumamoto, 일본, 861- 4193
- Saiseikai Kumamoto Hospital
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Mie-ken
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Matsusaka-shi, Mie-ken, 일본, 515-8544
- Matsusaka Municipal Hospital
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Miyagi
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Sendai, Miyagi, 일본, 980-0873
- Sendai Kousei Hospital
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Niigata
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Niigata, Niigata, 일본, 961-8566
- Niigata Cancer Center Hospital
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Osaka
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Hirakata-shi, Osaka, 일본, 573-1191
- Kansai Medical University Hospital
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Osaka, Osaka, 일본, 541-8567
- Osaka International Cancer Institute
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Sakai-shi, Osaka, 일본, 591-8555
- NHO Kinki-Chuo Chest Medical Center
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Tochigi
-
Shimotsuga-gun, Tochigi, 일본, 321-0293
- Dokkyo Medical University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, 일본, 113-8431
- Juntendo University Hospital
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Bunkyō-Ku, Tokyo, 일본, 113-8677
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Toyko
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Kōtoku, Toyko, 일본, 135-8550
- The Cancer Institute Hospital of JFCR
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Ōta-ku, Toyko, 일본, 143-8541
- Toho University Omori Medical Center
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Yamaguchi
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Iwakuni-shi, Yamaguchi, 일본, 740-8510
- NHO Iwakuni Clinical Center
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Ube-shi, Yamaguchi, 일본, 755-0241
- Yamaguchi-Ube Medical Center
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-
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Beijing, 중국, 100142
- Peking University Cancer Hospital
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Beijing, 중국, 100044
- Peking University Peoples Hospital
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Cangzhou, 중국, 610001
- Cangzhou People's Hospital
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Changsha, 중국, 410013
- Hunan Cancer Hospital
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Chongqing, 중국, 400042
- Army Medical Center of PLA
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Guangzhou, 중국, 510095
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University
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Haikou, 중국, 570208
- Haikou People's Hospital
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Hanghzou, 중국, 310003
- The First Affiliated Hospital of College of Medicine Zhejiang University
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Harbin, 중국, 150081
- Harbin Medical University Cancer Hospital
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Hohhot, 중국, 10050
- Inner Mongolia Medical University- the Affiliated Hospital
-
Jiamusi, 중국, 154007
- Jiamusi Tumor and Tuberculosis Hospital
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Kunming, 중국, 650118
- Yunnan Cancer Hospital
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Linyi, 중국, 276000
- Linyi Cancer Hospital
-
Nanchang, 중국, 330006
- The First Affiliated Hospital of Nanchang University
-
Nanjing, 중국, 210029
- Jiangsu Province Hospital
-
Neijiang, 중국, 641000
- The Second People's Hospital of Neijiang
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Shanghai, 중국, 200433
- Shanghai Pulmonary Hospital
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Shanghai Shi, 중국, 200032
- Fudan University Shanghai Cancer Center
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Shenyang, 중국, 110001
- The First Hospital of China Medical University
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Shenyang, 중국, 110801
- Liaoning Cancer Hospital& Institute
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Tianjin, 중국, 300052
- Tianjin Medical University General Hospital
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Wuhan, 중국, 430079
- Hubei Cancer Hospital
-
Wuhan, 중국, 430022
- Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
-
Xi'an, 중국, 710061
- The First Affiliate Hospitalof Xi'An Jiaotong University
-
Xiamen, 중국, 361001
- The First Affiliated Hospital Xiamen University
-
Xiangyang, 중국, 441000
- Xiangyang Central Hospital- 5 Lumen Avenue
-
Ürümqi, 중국, 830000
- Xinjiang Tumor Hospital
-
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Guangxi
-
Nanning, Guangxi, 중국, 530021
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Henan
-
Zhengzhou, Henan, 중국, 450008
- Henan Cancer Hospital
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-
Jilin
-
Changchun, Jilin, 중국, 130012
- Jilin Cancer Hospital
-
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Sichuan
-
Chengdu, Sichuan, 중국, 610049
- Sichuan Cancer Hospital
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-
-
-
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Santiago, 칠레, 7500000
- Oncovida
-
Santiago, 칠레, 7500921
- Fundación Arturo Pérez López
-
Santiago, 칠레, 7501010
- Orlandi Oncología
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Viña del Mar, 칠레, 254-0488
- Centro de Investigaciones Clinicas Vina Del Mar
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Santiago Metropolitan
-
Santiago, Santiago Metropolitan, 칠레, 7500653
- Centro de Estudios Clínicos SAGA
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-
-
-
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Montreal, 캐나다, H4A 3J2
- McGill University Health Centre
-
-
-
-
-
Bangkok, 태국, 10700
- Siriraj Hospital
-
Bangkok, 태국, 10330
- Faculty of Medicine Chulalongkorn University
-
-
Changwat Khon Kaen
-
Muaeng, Changwat Khon Kaen, 태국, 40002
- Srinagarind Hospital
-
-
Changwat Songkhla
-
Hat Yai, Changwat Songkhla, 태국, 90110
- Prince of Songkla University PSU - Faculty of Medicine
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-
-
-
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Adana, 터키 (Türkiye), 1130
- Adana Acibadem Hospital
-
Antalya, 터키 (Türkiye), 7070
- Akdeniz University Hospital
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Bornova-İzmir, 터키 (Türkiye), 35100
- Ege University
-
Istanbul, 터키 (Türkiye), 34772
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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Seyhan /Adana, 터키 (Türkiye), 1140
- Medical Park Seyhan Hospital
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Çankaya, 터키 (Türkiye), 06520
- Memorial Ankara Hospital Ankara
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-
-
-
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Lisbon, 포르투갈, 1400-038
- Centro Clinico Champalimau
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Porto, 포르투갈, 4100-180
- Hospital CUF Porto
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Porto, 포르투갈, 4099-001
- Centro Hospitalar e Universitário do Porto
-
Porto, 포르투갈, 4200-072
- Instituto Portuguas de Oncologia do Porto Francisco Gentil
-
Porto, 포르투갈, 4200-319
- Centro Hospitalar Universitário de São João
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-
-
-
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Bialystok, 폴란드, 15-450
- II Klinika Chorob Pluc I Gruzlicy
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Lublin, 폴란드, 20-064
- MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
-
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Iodzkie
-
Lodz, Iodzkie, 폴란드, 93-338
- Instytut Centrum Zdrowia Matki Polki
-
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Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, 폴란드, 81-519
- Szpitale Pomorskie Sp. z o.o.
-
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, 폴란드, 70-784
- Dom Lekarski SA
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-
-
-
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Avignon, 프랑스, 84000
- Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
-
Bordeaux, 프랑스, 33076
- Institut Bergonie
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Bordeaux, 프랑스, 33075
- Bordeaux University Hospital - Hopital Saint Andre
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Lille, 프랑스, 59000
- Centre Hospitalier Universitaire de Lille
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Lyon, 프랑스, 69008
- Centre Leon Berard
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Marseille, 프랑스, 13273
- Institut Paoli-Calmettes
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Marseille, 프랑스, 13015
- APHM - Hopital Nord
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Montpellier, 프랑스, 34295
- Centre Hospitalier Universitaire de Montpellier
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Nantes, 프랑스, 44093
- CHU de Nantes
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Nantes, 프랑스, 44277
- Hopital prive du Confluent
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Paris, 프랑스, 75970
- AP-HP - Hopital Tenon
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Poitiers, 프랑스, 86000
- CHU de Poitier Pole Regional de Cancerologie
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Suresnes, 프랑스, 92150
- Hopital FOCH
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-
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Budapest, 헝가리, 1083
- Semmelweis University Department of Pulmonology
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Farkasgyepű, 헝가리, 8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
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KecskemĂŠt, 헝가리, 6000
- Bkmk Hospital
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Székesfehérvár, 헝가리, 8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Törökbálint, 헝가리, 2045
- Pulmonology Hospital Torokbalint
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-
-
-
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Camperdown, 호주, 2050
- Chris Obrien Lifehouse
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Woodville South, 호주, 5011
- The Queen Elizabeth Hospital
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Victoria
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Heidelberg, Victoria, 호주, 3084
- Austin Hospital
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Mount Waverley, Victoria, 호주, 3149
- Peninsula and South Eastern Haematology and Oncology Group
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-
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Hong Kong, 홍콩
- Queen Elizabeth Hospital
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Hong Kong, 홍콩, 99999
- Prince of Wales Hospital / The Chinese University of Hong Kong 99999
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Pok Fu Lam, 홍콩, 999077
- Queen Mary Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
-
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
다른 이름들:
|
|
활성 비교기: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
기간: 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+)
기간: 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
기간: 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
기간: 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+)
기간: 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
기간: 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+
기간: 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+
기간: 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+
기간: 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+
기간: 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+
기간: 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+
기간: 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+
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: Baseline and up to 72 months
|
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. |
Baseline and up to 72 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 책임자: Global Clinical Leader, Daiichi Sankyo
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- DS1062-A-U304
- 2021-002555-10 (EudraCT 번호)
- KEYNOTE-C73 (기타 식별자: Merck)
- MK3475-C73 (기타 식별자: Merck)
- 2023-507933-12-00 (씨티스)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .