Undersøgelse af Dato-DXd Plus Pembrolizumab vs Pembrolizumab alene i førstelinjebehandlingen af forsøgspersoner med avanceret eller metastatisk NSCLC uden brugbare genomiske ændringer (TROPION-Lung08)
Et randomiseret, åbent, fase 3-forsøg med Dato-DXd Plus Pembrolizumab vs Pembrolizumab alene i behandlingsnaive forsøgspersoner med avanceret eller metastatisk PD-L1 høj (TPS ≥50 %) Ikke-småcellet lungekræft uden handlingsbare genomiske ændringer (TROPION) -Lunge08)
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).
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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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, Australien, 2050
- Chris Obrien Lifehouse
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Woodville South, Australien, 5011
- The Queen Elizabeth Hospital
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Victoria
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Heidelberg, Victoria, Australien, 3084
- Austin Hospital
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Mount Waverley, Victoria, Australien, 3149
- Peninsula and South Eastern Haematology and Oncology Group
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Aalst, Belgien, 9300
- Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
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Charleroi, Belgien, 6000
- Grand Hopital de Charleroi - Hopital Saint Joseph
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Ghent, Belgien, 9000
- Az Maria Middelares - Campus Maria Middelares
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Sint-Niklaas, Belgien, 9100
- AZ Nikolaas
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Caxias do Sul, Brasilien, 95020-972
- Instituto de Pesquisas em Saúde - IPS
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Curitiba, Brasilien, 81520-060
- Hospital Erasto Gaertner
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Ijuí, Brasilien, 98700-000
- Oncosite - Centro de Pesquisa Clinica Oncologia
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Itajaí, Brasilien, 88301-220
- Clínica de Neoplasias Litoral
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Pelotas, Brasilien, 96020-080
- UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
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Porto Alegre, Brasilien, 90050-170
- Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasilien, 20231-050
- Instituto Nacional de Câncer - INCA
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Santo André, Brasilien, 09060-870
- Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
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São Paulo, Brasilien, 01236-030
- Instituto de Ensino e Pesquisas Sao Lucas
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Taubaté, Brasilien
- 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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Birmingham, Det Forenede Kongerige, B9 5SS
- Birmingham Heartlands Hospital
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Nottingham, Det Forenede Kongerige, NG5 1PB
- Nottingham University Hospitals
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Ironwood Cancer and Research Center
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California
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Los Angeles, California, Forenede Stater, 90095
- UCLA HemOnc - Clinical Research Unit
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Santa Barbara, California, Forenede Stater, 93105
- Ridley-Tree Cancer Center
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Whittier, California, Forenede Stater, 90603
- The Oncology Institute of Hope and Innovation
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Whittier, California, Forenede Stater, 90602
- PIH Health Whittier Hospital
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Uch-Mhs D/B/A Memorial Health System
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins University
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Bethesda, Maryland, Forenede Stater, 20817
- American Oncology Partners of Maryland
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
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Foxborough, Massachusetts, Forenede Stater, 02035
- Dana Farber Cancer Institute - Foxborough
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South Weymouth, Massachusetts, Forenede Stater, 02190
- DFCI - South Shore Hospital
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03766
- Dartmouth Hitchcock Medical Center
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New Jersey
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East Brunswick, New Jersey, Forenede Stater, 08816
- Astera Cancer Care
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Freehold, New Jersey, Forenede Stater, 07728
- Regional Cancer Care Associates LLC
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New Brunswick, New Jersey, Forenede Stater, 08901
- Cooperman Barnabas Medical Center
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Paramus, New Jersey, Forenede Stater, 07652
- The Valley Hospital
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New York
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The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center
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Texas
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Irving, Texas, Forenede Stater, 75063
- Arizona Oncology NAHOA
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Irving, Texas, Forenede Stater, 75063
- Cancer Care Center of Brevard
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Irving, Texas, Forenede Stater, 75063
- Illinois Cancer Specialists
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Irving, Texas, Forenede Stater, 75063
- Maryland Oncology Hematology
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Irving, Texas, Forenede Stater, 75063
- Southern Cancer Center
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Irving, Texas, Forenede Stater, 75063
- Texas Oncology - Northeast Texas
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Irving, Texas, Forenede Stater, 75063
- Texas Oncology Gulf Coast
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Irving, Texas, Forenede Stater, 75063
- Texas Oncology McAllen
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San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center San Antonio
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Utah
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Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists
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Washington
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Lacey, Washington, Forenede Stater, 98503
- Providence Regional Cancer System
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Seattle, Washington, Forenede Stater, 98108
- VA Puget Sound Health Care System - VAPSHCS
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Avignon, Frankrig, 84000
- Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
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Bordeaux, Frankrig, 33076
- Institut Bergonie
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Bordeaux, Frankrig, 33075
- Bordeaux University Hospital - Hopital Saint Andre
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Lille, Frankrig, 59000
- Centre Hospitalier Universitaire de Lille
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Lyon, Frankrig, 69008
- Centre Leon Berard
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Marseille, Frankrig, 13273
- Institut Paoli-Calmettes
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Marseille, Frankrig, 13015
- APHM - Hopital Nord
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Montpellier, Frankrig, 34295
- Centre Hospitalier Universitaire de Montpellier
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Nantes, Frankrig, 44093
- CHU de Nantes
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Nantes, Frankrig, 44277
- Hopital prive du Confluent
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Paris, Frankrig, 75970
- AP-HP - Hopital Tenon
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Poitiers, Frankrig, 86000
- CHU de Poitier Pole Regional de Cancerologie
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Suresnes, Frankrig, 92150
- Hopital FOCH
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Athens, Grækenland, 11527
- Sotiria General Hosptial of Chest Diseases
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Ioannina, Grækenland, 45500
- University Hospital of Ioannina Uhi
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Neo Faliro, Grækenland, 18547
- Metropolitan Hospital
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Piraeus, Grækenland, 18547
- Metropolitan Hospital
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Thessaloniki, Grækenland, 54622
- Bioclinic Thessaloniki
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Thessaloniki, Grækenland, 55236
- St. Luke's Hospital
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Athens
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Neo Faliro, Athens, Grækenland, 14564
- Metropolitan Hospital
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's-Hertogenbosch, Holland, 5223 GZ
- Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
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Amsterdam, Holland, 1081 HZ
- Amsterdam Umc, Location Vumc
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Leiden, Holland, 2333 ZA
- Leiden University Medical Center
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Gelderland
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Arnhem, Gelderland, Holland, 6815 AD
- Rijnstate Ziekenhuis
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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, Italien, 70124
- IRCCS Istituto Oncologico Giovanni Paolo II
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Chieti, Italien, 66100
- UOC Oncologia
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Lucca, Italien, 55100
- Ospedale San Luca
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Milan, Italien, 20132
- IRCCS Ospedale San Raffaele
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Milan, Italien, 20141
- Irccs Istituto Europeo Di Oncologia
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Naples, Italien, 80131
- Azienda Ospedaliera dei Colli
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Perugia, Italien, 06132
- A.O. Perugia Santa Maria della Misericordia
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Rome, Italien, 133
- Policlinico Tor Vergata
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Rome, Italien, 144
- Ifo Regina Elena
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Varese, Italien, 21100
- Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
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Kofu, Japan
- Yamanashi Prefectural Central Hospital
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Kyoto, Japan, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Osaka, Japan, 560-8552
- Osaka Toneyama Medical Center
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Sapporo, Japan, 006-8555
- Teine Keijinkai Hospital
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Aomori
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Aomori, Aomori, Japan, 030-8553
- Aomori Prefectural Central Hospital
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Chiba
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Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Fukuoka, Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Kurume-shi, Fukuoka, Japan, 830-0011
- Kurume University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center
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Kumamoto
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Kumamoto, Kumamoto, Japan, 861- 4193
- Saiseikai Kumamoto Hospital
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Mie-ken
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Matsusaka-shi, Mie-ken, Japan, 515-8544
- Matsusaka Municipal Hospital
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Miyagi
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Sendai, Miyagi, Japan, 980-0873
- Sendai Kousei Hospital
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Niigata
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Niigata, Niigata, Japan, 961-8566
- Niigata Cancer Center Hospital
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Osaka
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Hirakata-shi, Osaka, Japan, 573-1191
- Kansai Medical University Hospital
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Osaka, Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Sakai-shi, Osaka, Japan, 591-8555
- NHO Kinki-Chuo Chest Medical Center
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Tochigi
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Shimotsuga-gun, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Bunkyō-Ku, Tokyo, Japan, 113-8677
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Toyko
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Kōtoku, Toyko, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
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Ōta-ku, Toyko, Japan, 143-8541
- Toho University Omori Medical Center
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Yamaguchi
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Iwakuni-shi, Yamaguchi, Japan, 740-8510
- NHO Iwakuni Clinical Center
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Ube-shi, Yamaguchi, Japan, 755-0241
- Yamaguchi-Ube Medical Center
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Beijing, Kina, 100142
- Peking University Cancer Hospital
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Beijing, Kina, 100044
- Peking University Peoples Hospital
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Cangzhou, Kina, 610001
- Cangzhou People's Hospital
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Changsha, Kina, 410013
- Hunan Cancer Hospital
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Chongqing, Kina, 400042
- Army Medical Center of PLA
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Guangzhou, Kina, 510095
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University
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Haikou, Kina, 570208
- Haikou People's Hospital
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Hanghzou, Kina, 310003
- The First Affiliated Hospital of College of Medicine Zhejiang University
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Harbin, Kina, 150081
- Harbin Medical University Cancer Hospital
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Hohhot, Kina, 10050
- Inner Mongolia Medical University- the Affiliated Hospital
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Jiamusi, Kina, 154007
- Jiamusi Tumor and Tuberculosis Hospital
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Kunming, Kina, 650118
- Yunnan Cancer Hospital
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Linyi, Kina, 276000
- Linyi Cancer Hospital
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Nanchang, Kina, 330006
- The First Affiliated Hospital of Nanchang University
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Nanjing, Kina, 210029
- Jiangsu Province Hospital
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Neijiang, Kina, 641000
- The Second People's Hospital of Neijiang
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Shanghai, Kina, 200433
- Shanghai Pulmonary Hospital
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Shanghai Shi, Kina, 200032
- Fudan University Shanghai Cancer Center
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Shenyang, Kina, 110001
- The First Hospital of China Medical University
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Shenyang, Kina, 110801
- Liaoning Cancer Hospital& Institute
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Tianjin, Kina, 300052
- Tianjin Medical University General Hospital
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Wuhan, Kina, 430079
- Hubei Cancer Hospital
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Wuhan, Kina, 430022
- Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
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Xi'an, Kina, 710061
- The First Affiliate Hospitalof Xi'An Jiaotong University
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Xiamen, Kina, 361001
- The First Affiliated Hospital Xiamen University
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Xiangyang, Kina, 441000
- Xiangyang Central Hospital- 5 Lumen Avenue
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Ürümqi, Kina, 830000
- Xinjiang Tumor Hospital
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Guangxi
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Nanning, Guangxi, Kina, 530021
- Guangxi Medical University Affiliated Tumor Hospital
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Henan
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Zhengzhou, Henan, Kina, 450008
- Henan Cancer Hospital
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Jilin
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Changchun, Jilin, Kina, 130012
- Jilin Cancer Hospital
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Sichuan
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Chengdu, Sichuan, Kina, 610049
- Sichuan Cancer Hospital
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Cuauhtémoc, Mexico, 06100
- Cryptex Investigacion Clinica Sa de Cv
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Guadalajara, Mexico, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Monterrey, Mexico, 64460
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
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Oaxaca City, Mexico, 68020
- Centro de Investigacion Clinica de Oaxaca (CICLO)
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San Luis Potosí City, Mexico, 78209
- Oncologico Potosino
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Bialystok, Polen, 15-450
- II Klinika Chorob Pluc I Gruzlicy
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Lublin, Polen, 20-064
- MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
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Iodzkie
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Lodz, Iodzkie, Polen, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polen, 81-519
- Szpitale Pomorskie Sp. z o.o.
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Polen, 70-784
- Dom Lekarski SA
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Lisbon, Portugal, 1400-038
- Centro Clinico Champalimau
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Porto, Portugal, 4100-180
- Hospital CUF Porto
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Porto, Portugal, 4099-001
- Centro Hospitalar e Universitário do Porto
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Porto, Portugal, 4200-072
- Instituto Portuguas de Oncologia do Porto Francisco Gentil
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Porto, Portugal, 4200-319
- Centro Hospitalar Universitário de São João
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Craiova, Rumænien, 200094
- Onco Clinic Consult SA
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Craiova, Rumænien, 200542
- Centrul de Oncologie Sf Nectarie S.R.L.
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Suceava, Rumænien, 720214
- Sc Sigmedical Services Srl
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Timișoara, Rumænien, 300166
- Oncocenter-Oncologie Clinica SRL
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Timișoara, Rumænien, 300239
- SC Oncomed SRL
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Baden, Schweiz, 5404
- Kantonsspital Baden
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Basel, Schweiz, 4031
- University Hospital Basel
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Liestal, Schweiz, A4410
- Kantonsspital Baselland
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Sankt Gallen, Schweiz
- Kantonsspital St. Gallen
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Barcelona, Spanien, 08036
- Hospital Clinic i Provincial de Barcelona
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Barcelona, Spanien, 8035
- Hospital Universitari Vall D'Hebron
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Lleida, Spanien, 25198
- Hospital Universitario Arnau de Vilanova - Lleida
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Madrid, Spanien, 28040
- Hospital Clinico San Carlos
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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spanien, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Málaga, Spanien, 29010
- Hospital Regional Universitario Malaga
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Ourense, Spanien, 32005
- CHUO
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Seville, Spanien, 41009
- Hospital Universitario Virgen Macarena
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Seville, Spanien, 41014
- Hospital Universitario de Valme
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Valencia, Spanien, 46026
- Hospital Universitari i Politècnic La Fe
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Zaragoza, Spanien, 50009
- Hospital Universitario Miguel Servet
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Daegu, Sydkorea, 42119
- Kyungpook National University Chilgok Hospital
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Goyang-si, Sydkorea, 10408
- National Cancer Center
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Seoul, Sydkorea, 6351
- Samsung Medical Center
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Seoul, Sydkorea, 6591
- The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
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Songpa-gu, Sydkorea, 5505
- Asan Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital
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Gyeongsangnam-do
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Jinju, Gyeongsangnam-do, Sydkorea, 52727
- Gyeongsang National University Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, Sydkorea, 28644
- Chungbuk National University Hospital
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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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Bangkok, Thailand, 10700
- Siriraj Hospital
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Bangkok, Thailand, 10330
- Faculty of Medicine Chulalongkorn University
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Changwat Khon Kaen
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Muaeng, Changwat Khon Kaen, Thailand, 40002
- Srinagarind Hospital
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Thailand, 90110
- Prince of Songkla University PSU - Faculty of Medicine
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Adana, Tyrkiet (Türkiye), 1130
- Adana Acibadem Hospital
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Antalya, Tyrkiet (Türkiye), 7070
- Akdeniz University Hospital
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Bornova-İzmir, Tyrkiet (Türkiye), 35100
- Ege University
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Istanbul, Tyrkiet (Türkiye), 34772
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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Seyhan /Adana, Tyrkiet (Türkiye), 1140
- Medical Park Seyhan Hospital
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Çankaya, Tyrkiet (Türkiye), 06520
- Memorial Ankara Hospital Ankara
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Berlin, Tyskland, 13125
- Evangelische Lungenklinik Berlin
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Esslingen am Neckar, Tyskland, 73730
- Klinikum Esslingen GmbH
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Großhansdorf, Tyskland, 22927
- LungenClinic Grosshansdorf
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München, Tyskland, 80336
- Klinikum der Universitaet Muenchen
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Budapest, Ungarn, 1083
- Semmelweis University Department of Pulmonology
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Farkasgyepű, Ungarn, 8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
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KecskemĂŠt, Ungarn, 6000
- Bkmk Hospital
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Székesfehérvár, Ungarn, 8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Törökbálint, Ungarn, 2045
- Pulmonology Hospital Torokbalint
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Klagenfurt, Østrig
- Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
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Vienna, Østrig, 1090
- Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
-
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Andre navne:
|
|
Aktiv komparator: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)
Tidsramme: 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+)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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+)
Tidsramme: 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
Tidsramme: 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+
Tidsramme: 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+
Tidsramme: 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+
Tidsramme: 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+
Tidsramme: 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+
Tidsramme: 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+
Tidsramme: 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+
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: Baseline and up to 72 months
|
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. |
Baseline and up to 72 months
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Global Clinical Leader, Daiichi Sankyo
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- DS1062-A-U304
- 2021-002555-10 (EudraCT nummer)
- KEYNOTE-C73 (Anden identifikator: Merck)
- MK3475-C73 (Anden identifikator: Merck)
- 2023-507933-12-00 (Ctis)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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