Studio di Dato-DXd Plus Pembrolizumab vs Pembrolizumab da solo nel trattamento di prima linea di soggetti con NSCLC avanzato o metastatico senza alterazioni genomiche attuabili (TROPION-Lung08)
23 settembre 2026 aggiornato da: Daiichi Sankyo
Uno studio randomizzato, in aperto, di fase 3 di Dato-DXd Plus Pembrolizumab vs Pembrolizumab da solo in soggetti naïve al trattamento con carcinoma polmonare non a piccole cellule avanzato o metastatico ad alto livello di PD-L1 (TPS ≥50%) senza alterazioni genomiche attuabili (TROPION -polmone08)
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).
Panoramica dello studio
Stato
Stato
Attivo, non reclutante
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
740
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
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Ciudad Autonoma de Buenos Aire, Argentina, 1125
- Fundacion CENIT para la investigación en Neurociencias
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Mar del Plata, Argentina, B7602CBM
- Hospital Privado de la Comunidad
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Pergamino, Argentina, 2700
- Centro de Investigación Pergamino S. A.
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Rosario, Argentina, S2001
- Sanatorio Parque
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Rosario, Argentina, S2000
- Instituto de Oncología de Rosario
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Rosario, Argentina, S2002
- Sanatorio Británico de Rosario
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San Juan, Argentina, 5400
- CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
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Viedma, Argentina, 8500
- Clinica Viedma SA
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Camperdown, Australia, 2050
- Chris Obrien Lifehouse
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Woodville South, Australia, 5011
- The Queen Elizabeth Hospital
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital
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Mount Waverley, Victoria, Australia, 3149
- Peninsula and South Eastern Haematology and Oncology Group
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Klagenfurt, Austria
- Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
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Vienna, Austria, 1090
- Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
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Aalst, Belgio, 9300
- Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
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Charleroi, Belgio, 6000
- Grand Hopital de Charleroi - Hopital Saint Joseph
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Ghent, Belgio, 9000
- Az Maria Middelares - Campus Maria Middelares
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Sint-Niklaas, Belgio, 9100
- AZ Nikolaas
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Caxias do Sul, Brasile, 95020-972
- Instituto de Pesquisas em Saúde - IPS
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Curitiba, Brasile, 81520-060
- Hospital Erasto Gaertner
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Ijuí, Brasile, 98700-000
- Oncosite - Centro de Pesquisa Clinica Oncologia
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Itajaí, Brasile, 88301-220
- Clínica de Neoplasias Litoral
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Pelotas, Brasile, 96020-080
- UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
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Porto Alegre, Brasile, 90050-170
- Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasile, 20231-050
- Instituto Nacional de Câncer - INCA
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Santo André, Brasile, 09060-870
- Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
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São Paulo, Brasile, 01236-030
- Instituto de Ensino e Pesquisas Sao Lucas
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Taubaté, Brasile
- Instituto do Cancer Brasil - Unidade Taubate
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Montreal, Canada, H4A 3J2
- McGill University Health Centre
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Santiago, Chile, 7500000
- Oncovida
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Santiago, Chile, 7500921
- Fundación Arturo Pérez López
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Santiago, Chile, 7501010
- Orlandi Oncología
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Viña del Mar, Chile, 254-0488
- Centro de Investigaciones Clinicas Vina Del Mar
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7500653
- Centro de Estudios Clínicos SAGA
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Beijing, Cina, 100142
- Peking University Cancer Hospital
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Beijing, Cina, 100044
- Peking University Peoples Hospital
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Cangzhou, Cina, 610001
- Cangzhou People's Hospital
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Changsha, Cina, 410013
- Hunan Cancer Hospital
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Chongqing, Cina, 400042
- Army Medical Center of PLA
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Guangzhou, Cina, 510095
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University
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Haikou, Cina, 570208
- Haikou People's Hospital
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Hanghzou, Cina, 310003
- The First Affiliated Hospital of College of Medicine Zhejiang University
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Harbin, Cina, 150081
- Harbin Medical University Cancer Hospital
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Hohhot, Cina, 10050
- Inner Mongolia Medical University- the Affiliated Hospital
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Jiamusi, Cina, 154007
- Jiamusi Tumor and Tuberculosis Hospital
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Kunming, Cina, 650118
- Yunnan Cancer Hospital
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Linyi, Cina, 276000
- Linyi Cancer Hospital
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Nanchang, Cina, 330006
- The First Affiliated Hospital of Nanchang University
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Nanjing, Cina, 210029
- Jiangsu Province Hospital
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Neijiang, Cina, 641000
- The Second People's Hospital of Neijiang
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Shanghai, Cina, 200433
- Shanghai Pulmonary Hospital
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Shanghai Shi, Cina, 200032
- Fudan University Shanghai Cancer Center
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Shenyang, Cina, 110001
- The First Hospital of China Medical University
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Shenyang, Cina, 110801
- Liaoning Cancer Hospital& Institute
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Tianjin, Cina, 300052
- Tianjin Medical University General Hospital
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Wuhan, Cina, 430079
- Hubei Cancer Hospital
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Wuhan, Cina, 430022
- Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
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Xi'an, Cina, 710061
- The First Affiliate Hospitalof Xi'An Jiaotong University
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Xiamen, Cina, 361001
- The First Affiliated Hospital Xiamen University
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Xiangyang, Cina, 441000
- Xiangyang Central Hospital- 5 Lumen Avenue
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Ürümqi, Cina, 830000
- Xinjiang Tumor Hospital
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Guangxi
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Nanning, Guangxi, Cina, 530021
- Guangxi Medical University Affiliated Tumor Hospital
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Henan
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Zhengzhou, Henan, Cina, 450008
- Henan Cancer Hospital
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Jilin
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Changchun, Jilin, Cina, 130012
- Jilin Cancer Hospital
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Sichuan
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Chengdu, Sichuan, Cina, 610049
- Sichuan Cancer Hospital
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Daegu, Corea del Sud, 42119
- Kyungpook National University Chilgok Hospital
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Goyang-si, Corea del Sud, 10408
- National Cancer Center
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Seoul, Corea del Sud, 6351
- Samsung Medical Center
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Seoul, Corea del Sud, 6591
- The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
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Songpa-gu, Corea del Sud, 5505
- Asan Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
- Seoul National University Bundang Hospital
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Gyeongsangnam-do
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Jinju, Gyeongsangnam-do, Corea del Sud, 52727
- Gyeongsang National University Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, Corea del Sud, 28644
- Chungbuk National University Hospital
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Avignon, Francia, 84000
- Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
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Bordeaux, Francia, 33076
- Institut Bergonie
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Bordeaux, Francia, 33075
- Bordeaux University Hospital - Hopital Saint Andre
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Lille, Francia, 59000
- Centre Hospitalier Universitaire de Lille
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Lyon, Francia, 69008
- Centre Leon Berard
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Marseille, Francia, 13273
- Institut Paoli-Calmettes
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Marseille, Francia, 13015
- APHM - Hopital Nord
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Montpellier, Francia, 34295
- Centre Hospitalier Universitaire de Montpellier
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Nantes, Francia, 44093
- CHU de Nantes
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Nantes, Francia, 44277
- Hopital prive du Confluent
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Paris, Francia, 75970
- AP-HP - Hopital Tenon
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Poitiers, Francia, 86000
- CHU de Poitier Pole Regional de Cancerologie
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Suresnes, Francia, 92150
- Hopital FOCH
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Berlin, Germania, 13125
- Evangelische Lungenklinik Berlin
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Esslingen am Neckar, Germania, 73730
- Klinikum Esslingen GmbH
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Großhansdorf, Germania, 22927
- LungenClinic Grosshansdorf
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München, Germania, 80336
- Klinikum der Universitaet Muenchen
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Kofu, Giappone
- Yamanashi Prefectural Central Hospital
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Kyoto, Giappone, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Osaka, Giappone, 560-8552
- Osaka Toneyama Medical Center
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Sapporo, Giappone, 006-8555
- Teine Keijinkai Hospital
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Aomori
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Aomori, Aomori, Giappone, 030-8553
- Aomori Prefectural Central Hospital
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Chiba
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Kashiwa-shi, Chiba, Giappone, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Giappone, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Giappone, 812-8582
- Kyushu University Hospital
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Fukuoka, Fukuoka, Giappone, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Kurume-shi, Fukuoka, Giappone, 830-0011
- Kurume University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Giappone, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Giappone, 241-8515
- Kanagawa Cancer Center
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Kumamoto
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Kumamoto, Kumamoto, Giappone, 861- 4193
- Saiseikai Kumamoto Hospital
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Mie-ken
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Matsusaka-shi, Mie-ken, Giappone, 515-8544
- Matsusaka Municipal Hospital
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Miyagi
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Sendai, Miyagi, Giappone, 980-0873
- Sendai Kousei Hospital
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Niigata
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Niigata, Niigata, Giappone, 961-8566
- Niigata Cancer Center Hospital
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Osaka
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Hirakata-shi, Osaka, Giappone, 573-1191
- Kansai Medical University Hospital
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Osaka, Osaka, Giappone, 541-8567
- Osaka International Cancer Institute
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Sakai-shi, Osaka, Giappone, 591-8555
- NHO Kinki-Chuo Chest Medical Center
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Tochigi
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Shimotsuga-gun, Tochigi, Giappone, 321-0293
- Dokkyo Medical University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Giappone, 113-8431
- Juntendo University Hospital
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Bunkyō-Ku, Tokyo, Giappone, 113-8677
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Toyko
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Kōtoku, Toyko, Giappone, 135-8550
- The Cancer Institute Hospital of JFCR
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Ōta-ku, Toyko, Giappone, 143-8541
- Toho University Omori Medical Center
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Yamaguchi
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Iwakuni-shi, Yamaguchi, Giappone, 740-8510
- NHO Iwakuni Clinical Center
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Ube-shi, Yamaguchi, Giappone, 755-0241
- Yamaguchi-Ube Medical Center
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Athens, Grecia, 11527
- Sotiria General Hosptial of Chest Diseases
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Ioannina, Grecia, 45500
- University Hospital of Ioannina Uhi
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Neo Faliro, Grecia, 18547
- Metropolitan Hospital
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Piraeus, Grecia, 18547
- Metropolitan Hospital
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Thessaloniki, Grecia, 54622
- Bioclinic Thessaloniki
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Thessaloniki, Grecia, 55236
- St. Luke's Hospital
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Athens
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Neo Faliro, Athens, Grecia, 14564
- Metropolitan Hospital
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Hong Kong, Hong Kong
- Queen Elizabeth Hospital
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Hong Kong, Hong Kong, 99999
- Prince of Wales Hospital / The Chinese University of Hong Kong 99999
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Pok Fu Lam, Hong Kong, 999077
- Queen Mary Hospital
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Bari, Italia, 70124
- IRCCS Istituto Oncologico Giovanni Paolo II
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Chieti, Italia, 66100
- UOC Oncologia
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Lucca, Italia, 55100
- Ospedale San Luca
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Milan, Italia, 20132
- IRCCS Ospedale San Raffaele
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Milan, Italia, 20141
- Irccs Istituto Europeo Di Oncologia
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Naples, Italia, 80131
- Azienda Ospedaliera dei Colli
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Perugia, Italia, 06132
- A.O. Perugia Santa Maria della Misericordia
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Rome, Italia, 133
- Policlinico Tor Vergata
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Rome, Italia, 144
- Ifo Regina Elena
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Varese, Italia, 21100
- Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
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Cuauhtémoc, Messico, 06100
- Cryptex Investigacion Clinica Sa de Cv
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Guadalajara, Messico, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Monterrey, Messico, 64460
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
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Oaxaca City, Messico, 68020
- Centro de Investigacion Clinica de Oaxaca (CICLO)
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San Luis Potosí City, Messico, 78209
- Oncologico Potosino
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's-Hertogenbosch, Olanda, 5223 GZ
- Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
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Amsterdam, Olanda, 1081 HZ
- Amsterdam Umc, Location Vumc
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Leiden, Olanda, 2333 ZA
- Leiden University Medical Center
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Gelderland
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Arnhem, Gelderland, Olanda, 6815 AD
- Rijnstate Ziekenhuis
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Bialystok, Polonia, 15-450
- II Klinika Chorob Pluc I Gruzlicy
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Lublin, Polonia, 20-064
- MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
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Iodzkie
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Lodz, Iodzkie, Polonia, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polonia, 81-519
- Szpitale Pomorskie Sp. z o.o.
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polonia, 70-784
- Dom Lekarski SA
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Lisbon, Portogallo, 1400-038
- Centro Clinico Champalimau
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Porto, Portogallo, 4100-180
- Hospital CUF Porto
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Porto, Portogallo, 4099-001
- Centro Hospitalar e Universitário do Porto
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Porto, Portogallo, 4200-072
- Instituto Portuguas de Oncologia do Porto Francisco Gentil
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Porto, Portogallo, 4200-319
- Centro Hospitalar Universitário de São João
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Birmingham, Regno Unito, B9 5SS
- Birmingham Heartlands Hospital
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Nottingham, Regno Unito, NG5 1PB
- Nottingham University Hospitals
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Craiova, Romania, 200094
- Onco Clinic Consult SA
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Craiova, Romania, 200542
- Centrul de Oncologie Sf Nectarie S.R.L.
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Suceava, Romania, 720214
- Sc Sigmedical Services Srl
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Timișoara, Romania, 300166
- Oncocenter-Oncologie Clinica SRL
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Timișoara, Romania, 300239
- SC Oncomed SRL
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Barcelona, Spagna, 08036
- Hospital Clinic i Provincial de Barcelona
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Barcelona, Spagna, 8035
- Hospital Universitari Vall D'Hebron
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Lleida, Spagna, 25198
- Hospital Universitario Arnau de Vilanova - Lleida
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Madrid, Spagna, 28040
- Hospital Clinico San Carlos
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Madrid, Spagna, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spagna, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Málaga, Spagna, 29010
- Hospital Regional Universitario Malaga
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Ourense, Spagna, 32005
- CHUO
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Seville, Spagna, 41009
- Hospital Universitario Virgen Macarena
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Seville, Spagna, 41014
- Hospital Universitario de Valme
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Valencia, Spagna, 46026
- Hospital Universitari i Politècnic La Fe
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Zaragoza, Spagna, 50009
- Hospital Universitario Miguel Servet
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Arizona
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Chandler, Arizona, Stati Uniti, 85224
- Ironwood Cancer and Research Center
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California
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Los Angeles, California, Stati Uniti, 90095
- UCLA HemOnc - Clinical Research Unit
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Santa Barbara, California, Stati Uniti, 93105
- Ridley-Tree Cancer Center
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Whittier, California, Stati Uniti, 90603
- The Oncology Institute of Hope and Innovation
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Whittier, California, Stati Uniti, 90602
- PIH Health Whittier Hospital
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80909
- Uch-Mhs D/B/A Memorial Health System
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Maryland
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Baltimore, Maryland, Stati Uniti, 21205
- Johns Hopkins University
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Bethesda, Maryland, Stati Uniti, 20817
- American Oncology Partners of Maryland
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber Cancer Institute
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Foxborough, Massachusetts, Stati Uniti, 02035
- Dana Farber Cancer Institute - Foxborough
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South Weymouth, Massachusetts, Stati Uniti, 02190
- DFCI - South Shore Hospital
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03766
- Dartmouth Hitchcock Medical Center
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New Jersey
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East Brunswick, New Jersey, Stati Uniti, 08816
- Astera Cancer Care
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Freehold, New Jersey, Stati Uniti, 07728
- Regional Cancer Care Associates LLC
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New Brunswick, New Jersey, Stati Uniti, 08901
- Cooperman Barnabas Medical Center
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Paramus, New Jersey, Stati Uniti, 07652
- The Valley Hospital
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New York
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The Bronx, New York, Stati Uniti, 10461
- Montefiore Medical Center
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Texas
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Irving, Texas, Stati Uniti, 75063
- Arizona Oncology NAHOA
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Irving, Texas, Stati Uniti, 75063
- Cancer Care Center of Brevard
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Irving, Texas, Stati Uniti, 75063
- Illinois Cancer Specialists
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Irving, Texas, Stati Uniti, 75063
- Maryland Oncology Hematology
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Irving, Texas, Stati Uniti, 75063
- Southern Cancer Center
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Irving, Texas, Stati Uniti, 75063
- Texas Oncology - Northeast Texas
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Irving, Texas, Stati Uniti, 75063
- Texas Oncology Gulf Coast
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Irving, Texas, Stati Uniti, 75063
- Texas Oncology McAllen
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San Antonio, Texas, Stati Uniti, 78229
- University of Texas Health Science Center San Antonio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84106
- Utah Cancer Specialists
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Washington
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Lacey, Washington, Stati Uniti, 98503
- Providence Regional Cancer System
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Seattle, Washington, Stati Uniti, 98108
- VA Puget Sound Health Care System - VAPSHCS
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Medical College of Wisconsin
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Baden, Svizzera, 5404
- Kantonsspital Baden
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Basel, Svizzera, 4031
- University Hospital Basel
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Liestal, Svizzera, A4410
- Kantonsspital Baselland
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Sankt Gallen, Svizzera
- Kantonsspital St. Gallen
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Bangkok, Tailandia, 10700
- Siriraj Hospital
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Bangkok, Tailandia, 10330
- Faculty of Medicine Chulalongkorn University
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Changwat Khon Kaen
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Muaeng, Changwat Khon Kaen, Tailandia, 40002
- Srinagarind Hospital
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Tailandia, 90110
- Prince of Songkla University PSU - Faculty of Medicine
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Kaohsiung City, Taiwan, 824
- E-Da Hospital
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Kaohsiung City, Taiwan, 833
- Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital Nckuh
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 112
- Koo Foundation Sun Yat-Sen Cancer Center
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital LinKou
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Adana, Turchia (Türkiye), 1130
- Adana Acibadem Hospital
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Antalya, Turchia (Türkiye), 7070
- Akdeniz University Hospital
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Bornova-İzmir, Turchia (Türkiye), 35100
- Ege University
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Istanbul, Turchia (Türkiye), 34772
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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Seyhan /Adana, Turchia (Türkiye), 1140
- Medical Park Seyhan Hospital
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Çankaya, Turchia (Türkiye), 06520
- Memorial Ankara Hospital Ankara
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Budapest, Ungheria, 1083
- Semmelweis University Department of Pulmonology
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Farkasgyepű, Ungheria, 8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
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KecskemĂŠt, Ungheria, 6000
- Bkmk Hospital
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Székesfehérvár, Ungheria, 8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Törökbálint, Ungheria, 2045
- Pulmonology Hospital Torokbalint
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
-
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
Lasso di tempo: 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+)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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+)
Lasso di tempo: 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
Lasso di tempo: 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+
Lasso di tempo: 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+
Lasso di tempo: 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+
Lasso di tempo: 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+
Lasso di tempo: 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+
Lasso di tempo: 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+
Lasso di tempo: 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+
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: Baseline and up to 72 months
|
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. |
Baseline and up to 72 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Direttore dello studio: Global Clinical Leader, Daiichi Sankyo
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
4 marzo 2022
Completamento primario (Stimato)
Completamento primario
4 marzo 2030
Completamento dello studio (Stimato)
Completamento dello studio
4 marzo 2032
Date di iscrizione allo studio
Primo inviato
Primo inviato
18 gennaio 2022
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
18 gennaio 2022
Primo Inserito (Effettivo)
Primo Inserito
31 gennaio 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
24 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 settembre 2026
Ultimo verificato
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- DS1062-A-U304
- 2021-002555-10 (Numero EudraCT)
- KEYNOTE-C73 (Altro identificatore: Merck)
- MK3475-C73 (Altro identificatore: Merck)
- 2023-507933-12-00 (Ctis)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Periodo di condivisione IPD
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Criteri di accesso alla condivisione IPD
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .