TrialPath
Recruiting

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

NCT06899126 · Daiichi Sankyo
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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)
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. 1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I. 2. HER2-targeted antibody-based anticancer therapy. 5. 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: 1. 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. 2. Has a QTc prolongation to \>480 ms based on the average of the Screening triplicate 12- lead ECG. 3. 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. 4. Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to: 1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion). 2. 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. 5. Had a prior complete pneumonectomy.
Study design
Enrollment target: 686 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-24
Estimated completion: 2032-11-24
Last updated: 2026-07-21
Interventions
Drug: Trastuzumab DeruxtecanDrug: pembrolizumabDrug: PemetrexedDrug: Platinum Chemotherapy
Primary outcomes
  • Progression Free Survival by Blinded Independent Central Review (From date of randomization to the date of radiographic disease progression or death due to any cause, up to approximately 54 months)
Sponsor
Daiichi Sankyo · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactContact for Trial Information · contact · CTRinfo_us@daiichisankyo.com · 908-992-6400
All locations (237)
Alaska Oncology & Hematology, LLCRecruiting
Anchorage, Alaska, United States
Orange Coast Memorial Medical Center Fountain ValleyRecruiting
Fountain Valley, California, United States
California Research InstituteRecruiting
Los Angeles, California, United States
Los Angeles Cancer Network (LACN)Recruiting
Los Angeles, California, United States
Providence Medical FoundationRecruiting
Santa Rosa, California, United States
Bay Pines VA Healthcare SystemRecruiting
Bay Pines, Florida, United States
Lynn Cancer Institute CenterRecruiting
Boca Raton, Florida, United States
Holy Cross HospitalRecruiting
Fort Lauderdale, Florida, United States
Mid-Florida Hematology & Oncology Centers, P.A.Recruiting
Orange City, Florida, United States
BRCR Global PlantationRecruiting
Plantation, Florida, United States
Cleveland Clinic Florida - WestonRecruiting
Weston, Florida, United States
Piedmont Cancer Institute OneOncologyRecruiting
Atlanta, Georgia, United States
The Queens Medical CenterRecruiting
Honolulu, Hawaii, United States
Hope and Healing Cancer ServicesRecruiting
Hinsdale, Illinois, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Logan Health ResearchRecruiting
Kalispell, Montana, United States
Renown Regional Medical CenterRecruiting
Reno, Nevada, United States
Clinical Research AllianceActive Not Recruiting
Westbury, New York, United States
FirstHealth Cancer CenterRecruiting
Pinehurst, North Carolina, United States
Carolina Cancer Research CenterRecruiting
Wilson, North Carolina, United States
Gabrail Cancer CenterRecruiting
Canton, Ohio, United States
St. Charles Health SystemRecruiting
Bend, Oregon, United States
University of Texas M. D. Anderson Cancer CenterRecruiting
Houston, Texas, United States
Lumi ResearchRecruiting
Kingwood, Texas, United States
Summit Cancer Treatment CenterRecruiting
Spokane, Washington, United States
CINME - Centro De Investigaciones MetabolicasRecruiting
Buenos Aires, Argentina
Hospital Italiano de Buenos AiresRecruiting
Buenos Aires, Argentina
Instituto Argentino de Diagnostico y TratamientoRecruiting
Buenos Aires, Argentina
Instituto de Investigaciones Metabolicas (IDIM)Recruiting
Buenos Aires, Argentina
Centro de Investigaciones Medicas y Desarrollo LC SRL (LC Investigacion)Recruiting
Ciudad Autonoma Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Cordoba S.A.Recruiting
Córdoba, Argentina
Centro de Investigacion Pergamino SARecruiting
Pergamino, Argentina
Hospital Universitario AustralRecruiting
Pilar, Argentina
Sanatorio Britanico S.A.Recruiting
Rosario, Argentina
Instituto de Oncologia de RosarioRecruiting
Rosario, Argentina
Instituto Medico de la Fundacion Estudios ClinicosRecruiting
Rosario, Argentina
Sanatorio Parque S.A.Recruiting
Rosario, Argentina
Instituto San MarcosRecruiting
San Juan, Argentina
Grand Hôpital de Charleroi-Les ViviersRecruiting
Gilly, Belgium
Chu Helora Hospital La Louvière Site JolimontRecruiting
La Louvière, Belgium
Chu de LiăgeRecruiting
Liège, Belgium
CHU Helora-Hospital de MonsRecruiting
Mons, Belgium
Hospital de Cancer de Barretos - Fundacao Pio XIIRecruiting
Barretos, Brazil
Centro de Pesquisas Clinica ReichowRecruiting
Blumenau, Brazil
CIONC-Centro Integrado de Oncologia de CuritibaRecruiting
Curitiba, Brazil
CRIO - Centro Regional Integrado de OncologiaRecruiting
Fortaleza, Brazil
Liga Norte-Rio-Grandense Contra o CâncerRecruiting
Natal, Brazil
Hospital Ernesto DornellesRecruiting
Porto Alegre, Brazil
Hospital São Lucas da PUCRSRecruiting
Porto Alegre, Brazil
Hospital Nossa Senhora Da ConceiçãoRecruiting
Porto Alegre, Brazil
Centro de Tratamento Oncologico (CTO)Recruiting
Ribeirão Preto, Brazil
Hospital das Clínicas FMRP-USPRecruiting
Ribeirão Preto, Brazil
Oncoclínicas Rio de JaneiroRecruiting
Rio de Janeiro, Brazil
Instituto Dâor Pesquisa E Ensino - Rio de JaneiroRecruiting
Rio de Janeiro, Brazil
Obras Sociais Irmã Dulce - Hospital Santo AntônioRecruiting
Salvador, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e OncologiaRecruiting
Santo André, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoRecruiting
Sao Jose Rio Preto, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de OliveiraRecruiting
São Paulo, Brazil
Centro Paulista de Oncologia S ARecruiting
Vila Olímpia, Brazil
BiocenterRecruiting
Concepción, Chile
Orlandi OncologiaRecruiting
Santiago, Chile
Centro de Oncologia de PrecisionRecruiting
Santiago, Chile
Hospital Clinico Universidad de ChileRecruiting
Santiago, Chile
Centro de Investigacion Clinica Bradford HillRecruiting
Santiago, Chile
Clinica Redsalud VitacuraRecruiting
Santiago, Chile
Beijing Cancer HospitalRecruiting
Beijing, China
China-Japan Friendship hospitalRecruiting
Beijing, China
Jilin Cancer HospitalRecruiting
Changchun, China
The First Hospital of Jilin UniversityRecruiting
Changchun, China
Hunan Cancer HospitalRecruiting
Changsha, China
Sichuan Cancer HospitalRecruiting
Chengdu, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, China
Chongqing University Cancer HospitalRecruiting
Chongqing, China
Nanfang Hospital of Southern Medical UniversityRecruiting
Guangzhou, China
Sir Run Run Shaw Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, China
Anhui Provincial HospitalRecruiting
Hefei, China
The Second Hospital of Anhui Medical UniversityRecruiting
Hefei, China
Hong Kong Integrated Oncology CentreRecruiting
Hong Kong, China
Cancer Hospital of Shandong First Medical UniversityRecruiting
Jinan, China
Hong Kong United Oncology CentreRecruiting
Jordan, China
Linyi Cancer HospitalRecruiting
Linyi, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
Jiangsu Province HospitalRecruiting
Nanjing, China
The Second People's Hospital of NeijiangRecruiting
Neijiang, China
Shanghai East HospitalRecruiting
Shanghai, China
The First Hospital of China Medical UniversityRecruiting
Shenyang, China
Liaoning Cancer Hospital & InstituteRecruiting
Shenyang, China
Shanxi Provincial Cancer HospitalRecruiting
Taiyuan, China
Tianjin Medical University General HospitalRecruiting
Tianjin, China
Hubei Cancer HospitalRecruiting
Wuhan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & TechnologyRecruiting
Wuhan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, China
Xiangyang Central HospitalRecruiting
Xiangyang, China
Henan Cancer HospitalRecruiting
Zhengzhou, China
CHU Angers - Hôpital LarreyRecruiting
Angers, France
Institut BergoniéRecruiting
Bordeaux, France
Hăpital Ambroise ParăRecruiting
Boulogne-Billancourt, France
Hospices Civils de LyonRecruiting
Bron, France
Centre Hospitalier Intercommunal de CréteilRecruiting
Créteil, France
Centre Georges Francois LeclercRecruiting
Dijon, France
Hopital Albert Calmette - CHU LilleRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
Assistance Publique-Hôpitaux de MarseilleRecruiting
Marseille, France
Clinique ClementvilleRecruiting
Montpellier, France
Hăpital Privă Du ConfluentRecruiting
Nantes, France
Hopital Bichat - Claude BernardRecruiting
Paris, France
Chu Nantes - Hăpital Guillaume Et Renă Laă NnecRecruiting
Saint-Herblain, France
Institut de Cancerologie de L'OuestRecruiting
Saint-Herblain, France
Hăpital FochRecruiting
Suresnes, France
Hopital LarreyRecruiting
Toulouse, France
Universitatsmedizin MainzRecruiting
Essen, Germany
Klinikum Esslingen GmbHRecruiting
Esslingen am Neckar, Germany
Universitaetsmedizin MannheimRecruiting
Manheim, Germany
Universtitaetsklinikum EssenRecruiting
Nordrhein Westfalen, Germany
General Hospital of Athens of Chest Diseases "SOTIRIA"Recruiting
Athens, Greece
'Henry Dynant' Hospital CenterRecruiting
Athens, Greece
National and Kapodistrian University of Athens (Nkua)-University General Hospital AttikonRecruiting
Athens, Greece
University General Hospital of LarissaRecruiting
Larissa, Greece
Metropolitan HospitalRecruiting
Neo Faliro, Greece
St Luke's HospitalRecruiting
Panórama, Greece
University General Hospital of PatrasRecruiting
Pátrai, Greece
Special Anticancer Hospital of Piraeus 'Metaxa'Recruiting
Piraeus, Greece
General Hospital PapageorgiouRecruiting
Thessaloniki, Greece
Interbalkan Hospital of ThessalonikiRecruiting
Thessaloniki, Greece
Queen Elizabeth HospitalRecruiting
Hong Kong, Hong Kong
The University of Hong KongRecruiting
Hong Kong, Hong Kong
The Chinese University of Hong KongRecruiting
Shatin, Hong Kong
Gleneagles Hospital Hong KongRecruiting
Wong Chuk Hang, Hong Kong
Mazumdar Shaw Medical CenterRecruiting
Bangalore, India
All India Institute of Medical SciencesRecruiting
Bhubaneswar, India
Narayana Superspeciality HospitalRecruiting
Howrah, India
Yenepoya Medical College HospitalRecruiting
Mangalore, India
Deenanath Mangeshkar Hospital and Research CentreRecruiting
Pune, India
Nirmal Hospital Private LimitedRecruiting
Surat, India
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IrccsRecruiting
Bologna, Italy
Fondazione del Piemonte per l'Oncologia IRCCS CandioloRecruiting
Candiolo, Italy
Ospedale Santa CroceRecruiting
Fano, Italy
Istituto Nazionale Per La Ricerca Sul Cancro Di GenovaRecruiting
Genova, Italy
Presidio Ospedaliero Di LivornoRecruiting
Livorno, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Humanitas Istituto Clinico CataneseRecruiting
Misterbianco, Italy
Azienda Ospedaliero-Universitaria S.Luigi GonzagaRecruiting
Orbassano, Italy
Azienda Ospedaliera S.Giovanni AddolorataRecruiting
Roma, Italy
Istituto Nazionale Tumori Regina Elena IRCCSRecruiting
Roma, Italy
Centro Ricerche Cliniche di Verona s.r.l.Recruiting
Verona, Italy
Saitama Medical University International Medical CenterRecruiting
Hidaka-shi, Japan
Kansai Medical University HospitalRecruiting
Hirakata-shi, Japan
Hirosaki University HospitalRecruiting
Hirosaki-shi, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa-shi, Japan
St. Marianna University HospitalRecruiting
Kawasaki-shi, Japan
Hospital of the University of Occupational and Environmental HealthRecruiting
Kitakyushu-shi, Japan
Saiseikai Kumamoto HospitalRecruiting
Kumamoto, Japan
Kurume University HospitalRecruiting
Kurume-shi, Japan
Matsusaka Municipal HospitalRecruiting
Matsusaka-shi, Japan
NHO Okayama Medical CenterRecruiting
Okayama, Japan
Osaka City General HospitalRecruiting
Osaka, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Japan
Toho University Omori Medical CenterRecruiting
Ōta-ku, Japan
NHO Kinki-Chuo Chest Medical CenterRecruiting
Sakaishi, Japan
Keijinkai Teine Keijinkai HospitalRecruiting
Sapporo, Japan
Tokyo Medical University HospitalRecruiting
Shinjuku-ku, Japan
Shizuoka Cancer CenterRecruiting
Sunto-gun, Japan
Ehime University HospitalRecruiting
Toon-shi, Japan
Fujita Health University HospitalRecruiting
Toyoake-shi, Japan
Wakayama Medical University HospitalRecruiting
Wakayama, Japan
Kanagawa Cancer CenterRecruiting
Yokohama, Japan
Tottori University HospitalRecruiting
Yonago-shi, Japan
Gleneagles Hospital PenangRecruiting
Jalan Pangkor, Malaysia
Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan AfzanRecruiting
Kuantan, Malaysia
Beacon Hospital Sdn BhdRecruiting
Petaling Jaya, Malaysia
Wojewodzki Szpital Im. SW. Ojca Pio W PrzemysluRecruiting
Rzeszów, Poland
Hospital da LuzRecruiting
Lisbon, Portugal
Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido ValenteRecruiting
Lisbon, Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo AntónioRecruiting
Porto, Portugal
Hospital CUF PortoRecruiting
Porto, Portugal
Delta Health Care S.R.LRecruiting
Bucharest, Romania
Colentina HospitalRecruiting
Bucharest, Romania
Memorial Healthcare International S R LRecruiting
Bucharest, Romania
Institutul OncologicRecruiting
Cluj-Napoca, Romania
Spitalul Clinic Militar de Urgenta Dr. "Constantin Papilian" Cluj-NapocaRecruiting
Cluj-Napoca, Romania
Centrul de Oncologie Sfantul Nectarie CraiovaRecruiting
Craiova, Romania
Institutul Regional de Oncologie LasiRecruiting
Lasi, Romania
S.C R.T.C Radiology Therapeutic Center S.R.LRecruiting
Otopeni, Romania
Spitalul Municipal PloiestiRecruiting
Ploieşti, Romania
Chungbuk National University HospitalRecruiting
Cheongju-si, South Korea
National Cancer CenterRecruiting
Goyang-si, South Korea
Gyeongsang National University HospitalRecruiting
Jinju, South Korea
CHA Bundang Medical Center, CHA UniversityRecruiting
Seongnam, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea, St. Vincent's HospitalRecruiting
Suwon, South Korea
Hospital del MarRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i ReynalsRecruiting
Barcelona, Spain
Hospital Universitari DexeusRecruiting
Barcelona, Spain
Hospital Universitari Vall d'Hebron - VHIORecruiting
Barcelona, Spain
Hospital Provincial de CastellonRecruiting
Castellion, Spain
Complejo Hospitalario Universitario Insular-Materno InfantilRecruiting
Las Palmas de Gran Canaria, Spain
Hospital Universitario Lucus AugustiRecruiting
Lugo, Spain
Hospital General Universitario Gregorio MarañonRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Clinico San CarlosRecruiting
Madrid, Spain
Hospital Clinico Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Spain
Complejo Hospitalario Universitario de SantiagoRecruiting
Santiago de Compostela, Spain
Hospital Universitario Nuestra Señora de ValmeRecruiting
Seville, Spain
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
Chi Mei Hospital, LiouyingRecruiting
Tainan, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University Cancer CenterRecruiting
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Tri-Service General HospitalRecruiting
Taipei, Taiwan
Chang Gung Memorial Hospital,LinkouRecruiting
Taoyuan City, Taiwan
Siriraj HospitalRecruiting
Bangkok, Thailand
Phramongkutklao HospitalRecruiting
Bangkok, Thailand
Vajira HospitalRecruiting
Dusit, Thailand
Songklanagarind HospitalRecruiting
Hat Yai, Thailand
Chulabhorn HospitalRecruiting
Laksi, Thailand
Rajavithi HospitalRecruiting
Rajathevee, Thailand
Medical Park Seyhan HospitalRecruiting
Adana, Turkey (Türkiye)
Gulhane Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Hacettepe University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Medipol University Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Eastbourne District General HospitalRecruiting
Eastbourne, United Kingdom
Charing Cross HospitalRecruiting
London, United Kingdom
Altnagelvin Area HospitalRecruiting
Londonderry, United Kingdom
Nottingham University Hospitals City CampusRecruiting
Nottingham, United Kingdom
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer · TrialPath