Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer (DESTINY-Lung06)
July 17, 2026 updated by: Daiichi Sankyo
A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)
This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS <50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
686
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Contact for Trial Information
- Phone Number: 908-992-6400
- Email: CTRinfo_us@daiichisankyo.com
Study Locations
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Buenos Aires, Argentina
- Recruiting
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina
- Recruiting
- CINME - Centro De Investigaciones Metabolicas
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Buenos Aires, Argentina
- Recruiting
- Instituto Argentino de Diagnóstico y Tratamiento
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Buenos Aires, Argentina
- Recruiting
- Instituto de Investigaciones Metabolicas (IDIM)
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Ciudad Autonoma Buenos Aires, Argentina, 1113
- Recruiting
- Centro de Investigaciones Medicas y Desarrollo LC SRL (LC Investigacion)
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Córdoba, Argentina, 5000
- Recruiting
- Instituto de Investigaciones Clínicas Córdoba S.A.
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Pergamino, Argentina
- Recruiting
- Centro de Investigacion Pergamino SA
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Pilar, Argentina
- Recruiting
- Hospital Universitario Austral
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Rosario, Argentina
- Recruiting
- Instituto Médico de la Fundación Estudios Clínicos
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Rosario, Argentina
- Recruiting
- Sanatorio Parque S.A.
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Rosario, Argentina, 2000
- Recruiting
- Sanatorio Britanico S.A.
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Rosario, Argentina
- Recruiting
- Instituto de Oncologia de Rosario
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San Juan, Argentina
- Recruiting
- Instituto San Marcos
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Gilly, Belgium, 6060
- Recruiting
- Grand Hôpital de Charleroi-Les Viviers
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La Louvière, Belgium, 7100
- Recruiting
- Chu Helora Hospital La Louviere Site Jolimont
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Liège, Belgium
- Recruiting
- Chu de Liăge
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Mons, Belgium
- Recruiting
- CHU Helora-Hospital de Mons
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Barretos, Brazil, 14784-400
- Recruiting
- Hospital de Câncer de Barretos - Fundação Pio XII
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Blumenau, Brazil, 89010-340
- Recruiting
- Centro de Pesquisas Clinica Reichow
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Curitiba, Brazil, 80810-050
- Recruiting
- Cionc-Centro Integrado de Oncologia de Curitiba
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Fortaleza, Brazil, 60336-045
- Recruiting
- Crio - Centro Regional Integrado de Oncologia
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Natal, Brazil, 59075-740
- Recruiting
- Liga Norte-Rio-Grandense Contra o Câncer
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Porto Alegre, Brazil
- Recruiting
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Brazil, 90035-170
- Recruiting
- Hospital Ernesto Dornelles
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Porto Alegre, Brazil, 90619-000
- Recruiting
- Hospital São Lucas da PUCRS
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Ribeirão Preto, Brazil, 14026-596
- Recruiting
- Centro de Tratamento Oncologico (CTO)
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Ribeirão Preto, Brazil, 14051-140
- Recruiting
- Hospital das Clínicas FMRP-USP
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Rio de Janeiro, Brazil
- Recruiting
- Instituto Dâor Pesquisa E Ensino - Rio de Janeiro
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Rio de Janeiro, Brazil, 20230-130
- Recruiting
- Oncoclínicas Rio de Janeiro
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Salvador, Brazil, 40.414-120
- Recruiting
- Obras Sociais Irmã Dulce - Hospital Santo Antônio
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Santo André, Brazil, 09060-870
- Recruiting
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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Sao Jose Rio Preto, Brazil, 15090-000
- Recruiting
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São Paulo, Brazil
- Recruiting
- Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira
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Vila Olímpia, Brazil
- Recruiting
- Centro Paulista de Oncologia S A
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Concepción, Chile
- Recruiting
- Biocenter
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Santiago, Chile, 8380456
- Recruiting
- Hospital Clinico Universidad de Chile
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Santiago, Chile, 7500713
- Recruiting
- Orlandi Oncologia
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Santiago, Chile
- Recruiting
- Clinica Redsalud Vitacura
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Santiago, Chile, 7560908
- Recruiting
- Centro de Oncología de Precisión
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Santiago, Chile, 8420383
- Recruiting
- Centro de Investigacion Clinica Bradford Hill
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Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
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Beijing, China
- Recruiting
- China-Japan Friendship Hospital
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Changchun, China, 130000
- Recruiting
- Jilin Cancer Hospital
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Changchun, China
- Recruiting
- The First Hospital of Jilin University
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Changsha, China
- Recruiting
- Hunan Cancer Hospital
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Chengdu, China
- Recruiting
- West China Hospital, Sichuan University
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Chengdu, China
- Recruiting
- Sichuan Cancer Hospital
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Chongqing, China
- Recruiting
- Chongqing University Cancer Hospital
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Guangzhou, China
- Recruiting
- Nanfang Hospital of Southern Medical University
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Hangzhou, China
- Recruiting
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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Harbin, China
- Recruiting
- Harbin Medical University Cancer Hospital
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Hefei, China
- Recruiting
- Anhui Provincial Hospital
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Hefei, China
- Recruiting
- The Second Hospital of Anhui Medical University
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Hong Kong, China
- Recruiting
- Hong Kong Integrated Oncology Centre
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Jinan, China
- Recruiting
- Cancer Hospital of Shandong First Medical University
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Jordan, China
- Recruiting
- Hong Kong United Oncology Centre
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Linyi, China
- Recruiting
- LinYi Cancer Hospital
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Nanchang, China
- Recruiting
- The First Affiliated Hospital of Nanchang University
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Nanchang, China
- Recruiting
- The Second Affiliated Hospital of Nanchang University
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Nanjing, China
- Recruiting
- Jiangsu Province Hospital
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Neijiang, China
- Recruiting
- The Second People's Hospital of Neijiang
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Shanghai, China
- Recruiting
- Shanghai East Hospital
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Shenyang, China, 110001
- Recruiting
- The First Hospital of China Medical University
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Shenyang, China
- Recruiting
- Liaoning cancer Hospital & Institute
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Taiyuan, China
- Recruiting
- Shanxi Provincial Cancer Hospital
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Tianjin, China
- Recruiting
- Tianjin Medical University General Hospital
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Wuhan, China, 430079
- Recruiting
- Hubei Cancer Hospital
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Wuhan, China
- Recruiting
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Wuhan, China
- Recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
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Xiangyang, China
- Recruiting
- Xiangyang Central Hospital
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Zhengzhou, China, 450003
- Recruiting
- Henan Cancer Hospital
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Angers, France, 49933
- Recruiting
- CHU Angers - Hôpital Larrey
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Bordeaux, France
- Recruiting
- Institut Bergonie
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Boulogne-Billancourt, France
- Recruiting
- Hăpital Ambroise Pară
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Bron, France, 69677
- Recruiting
- Hospices Civils de Lyon
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Créteil, France, 94010
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
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Dijon, France, 21079
- Recruiting
- Centre Georges Francois Leclerc
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Lille, France
- Recruiting
- Hopital Albert Calmette - CHU Lille
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Lyon, France
- Recruiting
- Centre Leon Berard
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Marseille, France, 13915
- Recruiting
- Assistance Publique-Hôpitaux de Marseille
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Montpellier, France, 34070
- Recruiting
- Clinique Clementville
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Nantes, France
- Recruiting
- Hăpital Privă Du Confluent
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Paris, France, 75018
- Recruiting
- Hopital Bichat - Claude Bernard
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Saint-Herblain, France
- Recruiting
- Institut de Cancérologie de l'Ouest
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Saint-Herblain, France
- Recruiting
- Chu Nantes - Hăpital Guillaume Et Renă Laă Nnec
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Suresnes, France
- Recruiting
- Hăpital Foch
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Toulouse, France, 31059
- Recruiting
- Hôpital Larrey
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Essen, Germany, 60590
- Recruiting
- Universitätsmedizin Mainz
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Esslingen am Neckar, Germany, 73730
- Recruiting
- Klinikum Esslingen GmbH
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Manheim, Germany
- Recruiting
- UniversitaetsMedizin Mannheim
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Nordrhein Westfalen, Germany
- Recruiting
- Universtitaetsklinikum Essen
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Athens, Greece
- Recruiting
- 'Henry Dynant' Hospital Center
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Athens, Greece
- Recruiting
- National and Kapodistrian University of Athens (Nkua)-University General Hospital Attikon
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Athens, Greece, 11527
- Recruiting
- General Hospital of Athens of Chest Diseases "SOTIRIA"
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Larissa, Greece
- Recruiting
- University General Hospital of Larissa
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Neo Faliro, Greece, 18547
- Recruiting
- Metropolitan Hospital
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Panórama, Greece, 55236
- Recruiting
- St Luke's Hospital
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Piraeus, Greece
- Recruiting
- Special Anticancer Hospital of Piraeus 'Metaxa'
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Pátrai, Greece
- Recruiting
- University General Hospital of Patras
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Thessaloniki, Greece
- Recruiting
- Interbalkan Hospital of Thessaloniki
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Thessaloniki, Greece, 57010
- Recruiting
- General Hospital Papageorgiou
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Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
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Hong Kong, Hong Kong
- Recruiting
- Queen Elizabeth Hospital
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Shatin, Hong Kong
- Recruiting
- The Chinese University of Hong Kong
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Wong Chuk Hang, Hong Kong
- Recruiting
- Gleneagles Hospital Hong Kong
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Bangalore, India
- Recruiting
- Mazumdar Shaw Medical Center
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Bhubaneswar, India, 751019
- Recruiting
- All India Institute of Medical Sciences
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Howrah, India
- Recruiting
- Narayana Superspeciality Hospital
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Mangalore, India
- Recruiting
- Yenepoya Medical College Hospital
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Pune, India, 411004
- Recruiting
- Deenanath Mangeshkar Hospital and Research Centre
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Surat, India
- Recruiting
- Nirmal Hospital Private Limited
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Bologna, Italy
- Recruiting
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Candiolo, Italy
- Recruiting
- Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
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Fano, Italy, 61032
- Recruiting
- Ospedale Santa Croce
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Genova, Italy
- Recruiting
- Istituto Nazionale per la Ricerca sul Cancro di Genova
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Livorno, Italy
- Recruiting
- Presidio Ospedaliero Di Livorno
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Milan, Italy, 20132
- Recruiting
- Ospedale San Raffaele
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Misterbianco, Italy, 95045
- Recruiting
- Humanitas Istituto Clinico Catanese
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Orbassano, Italy, 10043
- Recruiting
- Azienda Ospedaliero-Universitaria S.Luigi Gonzaga
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Roma, Italy
- Recruiting
- Istituto Nazionale Tumori Regina Elena IRCCS
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Roma, Italy, 00184
- Recruiting
- Azienda Ospedaliera S.Giovanni Addolorata
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Verona, Italy
- Recruiting
- Centro Ricerche Cliniche di Verona s.r.l.
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Hidaka-shi, Japan
- Recruiting
- Saitama Medical University International Medical Center
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Hirakata-shi, Japan
- Recruiting
- Kansai Medical University Hospital
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Hirosaki-shi, Japan, 036-8563
- Recruiting
- Hirosaki University Hospital
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Kashiwa-shi, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
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Kawasaki-shi, Japan, 220-0011
- Recruiting
- St. Marianna University Hospital
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Kitakyushu-shi, Japan
- Recruiting
- Hospital of the University of Occupational and Environmental Health
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Kumamoto, Japan
- Recruiting
- Saiseikai Kumamoto Hospital
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Kurume-shi, Japan, 810-0001
- Recruiting
- Kurume University Hospital
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Matsusaka-shi, Japan
- Recruiting
- Matsusaka Municipal Hospital
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Okayama, Japan, 700-0815
- Recruiting
- NHO Okayama Medical Center
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Osaka, Japan, 533-0033
- Recruiting
- Osaka City General Hospital
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Osaka, Japan, 541-0045
- Recruiting
- Osaka International Cancer Institute
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Sakaishi, Japan
- Recruiting
- NHO Kinki-Chuo Chest Medical Center
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Sapporo, Japan
- Recruiting
- Keijinkai Teine Keijinkai Hospital
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Shinjuku-ku, Japan, 220-0004
- Recruiting
- Tokyo Medical University Hospital
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Sunto-gun, Japan
- Recruiting
- Shizuoka Cancer Center
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Toon-shi, Japan, 162-0821
- Recruiting
- Ehime University Hospital
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Toyoake-shi, Japan, 470-1192
- Recruiting
- Fujita Health University Hospital
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Wakayama, Japan
- Recruiting
- Wakayama Medical University Hospital
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Yokohama, Japan
- Recruiting
- Kanagawa Cancer Center
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Yonago-shi, Japan
- Recruiting
- Tottori University Hospital
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Ōta-ku, Japan
- Recruiting
- Toho University Omori Medical Center
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Jalan Pangkor, Malaysia, 10050
- Recruiting
- Gleneagles Hospital Penang
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Kuala Lumpur, Malaysia
- Recruiting
- Hospital Kuala Lumpur
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Kuantan, Malaysia
- Recruiting
- Hospital Tengku Ampuan Afzan
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Petaling Jaya, Malaysia
- Recruiting
- Beacon Hospital Sdn Bhd
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Rzeszów, Poland
- Recruiting
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
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Lisbon, Portugal, 1500-650
- Recruiting
- Hospital da Luz
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Lisbon, Portugal
- Recruiting
- Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido Valente
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Porto, Portugal, 4100-180
- Recruiting
- Hospital Cuf porto
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Porto, Portugal, 4099-001
- Recruiting
- Centro Hospitalar Do Porto, E.P.E. - Hospital de Santo António
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Bucharest, Romania, 14142
- Recruiting
- Delta Health Care S.R.L
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Bucharest, Romania
- Recruiting
- Colentina Hospital
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Bucharest, Romania
- Recruiting
- Memorial Healthcare International S R L
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Cluj-Napoca, Romania, 400015
- Recruiting
- Institutul Oncologic
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Cluj-Napoca, Romania, 400132
- Recruiting
- Spitalul Clinic Militar de Urgenta Dr. "Constantin Papilian" Cluj-Napoca
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Craiova, Romania, 200347
- Recruiting
- Centrul de Oncologie Sfantul Nectarie Craiova
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Lasi, Romania, 700483
- Recruiting
- Institutul Regional de Oncologie Lasi
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Otopeni, Romania
- Recruiting
- S.C R.T.C Radiology Therapeutic Center S.R.L
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Ploieşti, Romania
- Recruiting
- Spitalul Municipal Ploiesti
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Cheongju-si, South Korea, 28644
- Recruiting
- Chungbuk National University Hospital
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Goyang-si, South Korea, 10408
- Recruiting
- National Cancer Center
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Jinju, South Korea
- Recruiting
- Gyeongsang National University Hospital
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Seongnam, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
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Seongnam, South Korea, 13496
- Recruiting
- CHA Bundang Medical Center, CHA University
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Seoul, South Korea
- Recruiting
- Samsung Medical Center
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Seoul, South Korea
- Recruiting
- Asan Medical Center
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Seoul, South Korea, 3722
- Recruiting
- Severance Hospital, Yonsei University Health System
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Suwon, South Korea, 16247
- Recruiting
- The Catholic University of Korea, St. Vincent's Hospital
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Barcelona, Spain, 08003
- Recruiting
- Hospital del Mar
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic de Barcelona
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Barcelona, Spain
- Recruiting
- Hospital Universitari Dexeus
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Barcelona, Spain, 8908
- Recruiting
- ICO L'Hospitalet - Hospital Duran i Reynals
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Barcelona, Spain
- Recruiting
- Hospital Universitari Vall d'Hebron - VHIO
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Castellion, Spain
- Recruiting
- Hospital Provincial de Castellon
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Las Palmas de Gran Canaria, Spain, 35016
- Recruiting
- Complejo Hospitalario Universitario Insular-Materno Infantil
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Lugo, Spain, 27003
- Recruiting
- Hospital Universitario Lucus Augusti
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Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
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Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain
- Recruiting
- Hospital Universitario Clínico San Carlos
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Málaga, Spain
- Recruiting
- Hospital Regional Universitario de Málaga
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Málaga, Spain, 29010
- Recruiting
- Hospital Clinico Universitario Virgen de la Victoria
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Oviedo, Spain
- Recruiting
- Hospital Universitario Central de Asturias
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Santiago de Compostela, Spain, 15706
- Recruiting
- Complejo Hospitalario Universitario de Santiago
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Seville, Spain, 41014
- Recruiting
- Hospital Universitario Nuestra Senora De Valme
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Kaohsiung City, Taiwan
- Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taichung, Taiwan
- Recruiting
- Taichung Veterans General Hospital
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Tainan, Taiwan
- Recruiting
- National Cheng Kung University Hospital
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Tainan, Taiwan
- Recruiting
- Chi Mei Hospital, Liouying
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Taipei, Taiwan
- Recruiting
- Taipei Veterans General Hospital
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Taipei, Taiwan
- Recruiting
- Tri-Service General Hospital
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Taipei, Taiwan
- Recruiting
- Koo Foundation Sun Yat-Sen Cancer Center
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Taipei, Taiwan, 106
- Recruiting
- National Taiwan University Cancer Center
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Taoyuan City, Taiwan
- Recruiting
- Chang Gung Memorial Hospital,Linkou
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Bangkok, Thailand, 10700
- Recruiting
- Siriraj Hospital
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Bangkok, Thailand
- Recruiting
- Phramongkutklao Hospital
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Dusit, Thailand, 10300
- Recruiting
- Vajira Hospital
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Hat Yai, Thailand, 90110
- Recruiting
- Songklanagarind Hospital
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Laksi, Thailand
- Recruiting
- Chulabhorn Hospital
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Rajathevee, Thailand
- Recruiting
- Rajavithi Hospital
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Adana, Turkey (Türkiye)
- Recruiting
- Medical Park Seyhan Hospital
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Ankara, Turkey (Türkiye), 6010
- Recruiting
- Gulhane Training and Research Hospital
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Ankara, Turkey (Türkiye), 6100
- Recruiting
- Hacettepe University Medical Faculty
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Istanbul, Turkey (Türkiye), 34147
- Recruiting
- Medipol University Medical Faculty
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Eastbourne, United Kingdom, BN21 2UD
- Recruiting
- Eastbourne District General Hospital
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London, United Kingdom
- Recruiting
- Charing Cross Hospital
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Londonderry, United Kingdom, BT47 6SB
- Recruiting
- Altnagelvin Area Hospital
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Nottingham, United Kingdom, NG5 1PB
- Recruiting
- Nottingham University Hospitals City Campus
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Alaska
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Anchorage, Alaska, United States, 99508
- Recruiting
- Alaska Oncology & Hematology, LLC
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California
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Fountain Valley, California, United States, 97208
- Recruiting
- Orange Coast Memorial Medical Center Fountain Valley
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Los Angeles, California, United States, 90027
- Recruiting
- California Research Institute
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Los Angeles, California, United States, 91204
- Recruiting
- Los Angeles Cancer Network (LACN)
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Santa Rosa, California, United States, 95403
- Recruiting
- Providence Medical Foundation
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Florida
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Bay Pines, Florida, United States, 33744
- Recruiting
- Bay Pines VA Healthcare System
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Boca Raton, Florida, United States, 33486
- Recruiting
- Lynn Cancer Institute Center
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Fort Lauderdale, Florida, United States, 33308
- Recruiting
- Holy Cross Hospital
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Orange City, Florida, United States, 33763
- Recruiting
- Mid-Florida Hematology & Oncology Centers, P.A.
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Plantation, Florida, United States, 33321
- Recruiting
- BRCR Global Plantation
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Weston, Florida, United States, 33331
- Recruiting
- Cleveland Clinic Florida - Weston
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Georgia
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Atlanta, Georgia, United States, 30318
- Recruiting
- Piedmont Cancer Institute OneOncology
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Hawaii
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Honolulu, Hawaii, United States, 96813-2402
- Recruiting
- The Queens Medical Center
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Illinois
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Hinsdale, Illinois, United States, 60521
- Recruiting
- Hope and Healing Cancer Services
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Massachusetts
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Boston, Massachusetts, United States, 02216
- Recruiting
- Dana-Farber Cancer Institute
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Montana
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Kalispell, Montana, United States, 59901
- Recruiting
- Logan Health Research
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Nevada
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Reno, Nevada, United States, 89502
- Recruiting
- Renown Regional Medical Center
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New York
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Westbury, New York, United States, 11590
- Active, not recruiting
- Clinical Research Alliance
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North Carolina
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Pinehurst, North Carolina, United States, 28374
- Recruiting
- FirstHealth Cancer Center
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Wilson, North Carolina, United States, 27893
- Recruiting
- Carolina Cancer Research Center
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Ohio
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Canton, Ohio, United States, 44718
- Recruiting
- Gabrail Cancer Center
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Oregon
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Bend, Oregon, United States, 97701
- Recruiting
- St. Charles Health System
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas M. D. Anderson Cancer Center
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Kingwood, Texas, United States, 77339
- Recruiting
- Lumi Research
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Washington
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Spokane, Washington, United States, 99208
- Recruiting
- Summit Cancer Treatment Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.
Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.
- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
Histologically documented non-squamous locally advanced unresectable or metastatic
NSCLC and meets all of the following criteria:
Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on the local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting.
Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if non-squamous NSCLC is the predominant histology. Mixed tumors will be classified based on the predominant cell type.
Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose if their disease has progressed at least 6 months after the last dose date of adjuvant/neoadjuvant therapy.
- Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.
- HER2-targeted antibody-based anticancer therapy.
- Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.
Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.
Exclusion Criteria:
- Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period.
- Has a QTc prolongation to >480 ms based on the average of the Screening triplicate 12- lead ECG.
- Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:
- Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion).
- Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis).
Severe conditions are those defined as impacting daily activities and/or requiring use of supplemental oxygen.
- Had a prior complete pneumonectomy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm A: T-DXd + Pembrolizumab
Participants will receive T-DXd plus pembrolizumab
|
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Other Names:
pembrolizumab will be administered at a dose of 200 mg IV Q3W
Other Names:
|
|
Active Comparator: Arm B: Pemetrexed + Platinum Chemotherapy + Pembrolizumab
Participants will receive Pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab
|
pembrolizumab will be administered at a dose of 200 mg IV Q3W
Other Names:
Pemetrexed will be administered at a dose of 500 mg/m^2 IV Q3W
One of the following two will be administered in Arm B: Cisplatin at a dose of 75 mg/m^2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV Q3W |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival by Blinded Independent Central Review
Time Frame: From date of randomization to the date of radiographic disease progression or death due to any cause, up to approximately 54 months
|
PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause.
Tumor response will be determined by BICR assessment of tumor scans using RECIST v1.1.
|
From date of randomization to the date of radiographic disease progression or death due to any cause, up to approximately 54 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: From date of randomization to the date of death due to any cause, up to approximately 85 months
|
OS is defined as the time interval from the date of randomization to the date of death due to any cause.
|
From date of randomization to the date of death due to any cause, up to approximately 85 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2025
Primary Completion (Estimated)
April 24, 2030
Study Completion (Estimated)
November 24, 2032
Study Registration Dates
First Submitted
March 21, 2025
First Submitted That Met QC Criteria
March 21, 2025
First Posted (Actual)
March 27, 2025
Study Record Updates
Last Update Posted (Actual)
July 21, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Amino Acids, Peptides, and Proteins
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Glutamates
- Amino Acids, Acidic
- Amino Acids
- Amino Acids, Dicarboxylic
- Pemetrexed
- pembrolizumab
- trastuzumab deruxtecan
Other Study ID Numbers
- DS8201-793
- 2024-515658-26-00 (Ctis)
- KEYNOTE-G23 (Other Identifier: Merck Sharp & Dohme LLC)
- MK-3475-G23 (Other Identifier: Merck Sharp & Dohme LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data (IPD) on completed studies 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 Sharing Time Frame
Completed studies that has reached a global end or completion with all data set collected and analyzed, and 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 Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed 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 Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.