Non-small Cell Lung CancerPhase 3DESTINY-Lung06NCT06899126
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
A Phase 3 study testing Trastuzumab Deruxtecan, pembrolizumab and Pemetrexed in people with Non-small Cell Lung Cancer, run by Daiichi Sankyo at 246 sites in 24 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Trastuzumab Deruxtecan, pembrolizumab and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 246 sitesin 24 countries
- Study dates
- 24 Oct 2025to 24 Nov 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
246 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
246 sites in 24 countries
China31 sites, 31 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
- Recruiting
China-Japan Friendship hospital
Beijing
- Recruiting
Jilin Cancer Hospital
Changchun, 130000
- Recruiting
The First Hospital of Jilin University
Changchun
- Recruiting
Hunan Cancer Hospital
Changsha
- Recruiting
Sichuan Cancer Hospital
Chengdu
- Recruiting
West China Hospital, Sichuan University
Chengdu
- Recruiting
Chongqing University Cancer Hospital
Chongqing
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
- Recruiting
Anhui Provincial Hospital
Hefei
- Recruiting
The Second Hospital of Anhui Medical University
Hefei
- Recruiting
Hong Kong Integrated Oncology Centre
Hong Kong
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
- Recruiting
Hong Kong United Oncology Centre
Jordan
- Recruiting
Linyi Cancer Hospital
Linyi
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
- Recruiting
Jiangsu Province Hospital
Nanjing
- Recruiting
The Second People's Hospital of Neijiang
Neijiang
- Recruiting
Shanghai East Hospital
Shanghai
- Recruiting
The First Hospital of China Medical University
Shenyang, 110001
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan
- Recruiting
Tianjin Medical University General Hospital
Tianjin
- Recruiting
Hubei Cancer Hospital
Wuhan, 430079
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan
- Recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
- Recruiting
Xiangyang Central Hospital
Xiangyang
- Recruiting
Henan Cancer Hospital
Zhengzhou, 450003
United States26 sites, 26 recruiting
- Recruiting
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, 99508
- Recruiting
Piedmont Cancer Institute OneOncology
Atlanta, Georgia, 30318
- Recruiting
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
- Recruiting
St. Charles Health System
Bend, Oregon, 97701
- Recruiting
Lynn Cancer Institute Center
Boca Raton, Florida, 33486
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02216
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
- Recruiting
Orange Coast Memorial Medical Center Fountain Valley
Fountain Valley, California, 97208
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
- Recruiting
The Queens Medical Center
Honolulu, Hawaii, 96813-2402
- Recruiting
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Logan Health Research
Kalispell, Montana, 59901
- Recruiting
Lumi Research
Kingwood, Texas, 77339
- Recruiting
California Research Institute
Los Angeles, California, 90027
- Recruiting
Los Angeles Cancer Network (LACN)
Los Angeles, California, 91204
- Recruiting
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, 33763
- Recruiting
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
- Recruiting
BRCR Global Plantation
Plantation, Florida, 33321
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
- Recruiting
Summit Cancer Treatment Center
Spokane, Washington, 99208
- Recruiting
Clinical Research Alliance
Westbury, New York, 11590
- Recruiting
Cleveland Clinic Florida - Weston
Weston, Florida, 33331
- Recruiting
Carolina Cancer Research Center
Wilson, North Carolina, 27893
Japan22 sites, 22 recruiting
- Recruiting
Saitama Medical University International Medical Center
Hidaka-shi
- Recruiting
Kansai Medical University Hospital
Hirakata-shi
- Recruiting
Hirosaki University Hospital
Hirosaki-shi, 036-8563
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, 277-8577
- Recruiting
St. Marianna University Hospital
Kawasaki-shi, 220-0011
- Recruiting
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi
- Recruiting
Saiseikai Kumamoto Hospital
Kumamoto
- Recruiting
Kurume University Hospital
Kurume-shi, 810-0001
- Recruiting
Matsusaka Municipal Hospital
Matsusaka-shi
- Recruiting
NHO Okayama Medical Center
Okayama, 700-0815
- Recruiting
Osaka City General Hospital
Osaka, 533-0033
- Recruiting
Osaka International Cancer Institute
Osaka, 541-0045
- Recruiting
Toho University Omori Medical Center
Ōta-ku
- Recruiting
NHO Kinki-Chuo Chest Medical Center
Sakaishi
- Recruiting
Keijinkai Teine Keijinkai Hospital
Sapporo
- Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, 220-0004
- Recruiting
Shizuoka Cancer Center
Sunto-gun
- Recruiting
Ehime University Hospital
Toon-shi, 162-0821
- Recruiting
Fujita Health University Hospital
Toyoake-shi, 470-1192
- Recruiting
Wakayama Medical University Hospital
Wakayama
- Recruiting
Kanagawa Cancer Center
Yokohama
- Recruiting
Tottori University Hospital
Yonago-shi
Spain19 sites, 19 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006
- Recruiting
Hospital del Mar
Barcelona, 08003
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 8908
- Recruiting
Hospital Universitari Dexeus
Barcelona
- Recruiting
Hospital Universitari Vall d'Hebron - VHIO
Barcelona
- Recruiting
Complejo Asistencial Universitario de Burgos
Burgos, 9006
- Recruiting
Hospital Provincial de Castellon
Castellion
- Recruiting
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, 35016
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, 27003
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Clinico San Carlos
Madrid
- Recruiting
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Regional Universitario de Malaga
Málaga
- Recruiting
Hospital Universitario Central de Asturias
Oviedo
- Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706
- Recruiting
Hospital Universitario Nuestra Señora de Valme
Seville, 41014
Brazil17 sites, 17 recruiting
- Recruiting
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, 14784-400
- Recruiting
Centro de Pesquisas Clinica Reichow
Blumenau, 89010-340
- Recruiting
CIONC-Centro Integrado de Oncologia de Curitiba
Curitiba, 80810-050
- Recruiting
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, 60336-045
- Recruiting
Liga Norte-Rio-Grandense Contra o Câncer
Natal, 59075-740
- Recruiting
Hospital Ernesto Dornelles
Porto Alegre, 90035-170
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, 90619-000
- Recruiting
Hospital Nossa Senhora Da Conceição
Porto Alegre
- Recruiting
Centro de Tratamento Oncologico (CTO)
Ribeirão Preto, 14026-596
- Recruiting
Hospital das Clínicas FMRP-USP
Ribeirão Preto, 14051-140
- Recruiting
Oncoclínicas Rio de Janeiro
Rio de Janeiro, 20230-130
- Recruiting
Instituto Dâor Pesquisa E Ensino - Rio de Janeiro
Rio de Janeiro
- Recruiting
Obras Sociais Irmã Dulce - Hospital Santo Antônio
Salvador, 40.414-120
- Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, 09060-870
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, 15090-000
- Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira
São Paulo
- Recruiting
Centro Paulista de Oncologia S A
Vila Olímpia
France17 sites, 17 recruiting
- Recruiting
CHU Angers - Hôpital Larrey
Angers, 49933
- Recruiting
Institut Bergonié
Bordeaux
- Recruiting
Hăpital Ambroise Pară
Boulogne-Billancourt
- Recruiting
Hospices Civils de Lyon
Bron, 69677
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
- Recruiting
Centre Georges Francois Leclerc
Dijon, 21079
- Recruiting
Hopital Albert Calmette - CHU Lille
Lille
- Recruiting
Centre Leon Berard
Lyon
- Recruiting
Assistance Publique-Hôpitaux de Marseille
Marseille, 13915
- Recruiting
Clinique Clementville
Montpellier, 34070
- Recruiting
Hăpital Privă Du Confluent
Nantes
- Recruiting
Hopital Bichat - Claude Bernard
Paris, 75018
- Recruiting
Hopital Tenon
Paris, 75020
- Recruiting
Chu Nantes - Hăpital Guillaume Et Renă Laă Nnec
Saint-Herblain
- Recruiting
Institut de Cancerologie de L'Ouest
Saint-Herblain
- Recruiting
Hăpital Foch
Suresnes
- Recruiting
Hopital Larrey
Toulouse, 31059
Argentina13 sites, 13 recruiting
- Recruiting
CINME - Centro De Investigaciones Metabolicas
Buenos Aires
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires
- Recruiting
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires
- Recruiting
Instituto de Investigaciones Metabolicas (IDIM)
Buenos Aires
- Recruiting
Centro de Investigaciones Medicas y Desarrollo LC SRL (LC Investigacion)
Ciudad Autonoma Buenos Aires, 1113
- Recruiting
Instituto de Investigaciones Clinicas Cordoba S.A.
Córdoba, 5000
- Recruiting
Centro de Investigacion Pergamino SA
Pergamino
- Recruiting
Hospital Universitario Austral
Pilar
- Recruiting
Sanatorio Britanico S.A.
Rosario, 2000
- Recruiting
Instituto de Oncologia de Rosario
Rosario
- Recruiting
Instituto Medico de la Fundacion Estudios Clinicos
Rosario
- Recruiting
Sanatorio Parque S.A.
Rosario
- Recruiting
Instituto San Marcos
San Juan
Italy12 sites, 12 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Irccs
Bologna
- Recruiting
Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
Candiolo
- Recruiting
Ospedale Santa Croce
Fano, 61032
- Recruiting
Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
Genova
- Recruiting
Presidio Ospedaliero Di Livorno
Livorno
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Humanitas Istituto Clinico Catanese
Misterbianco, 95045
- Recruiting
Azienda Ospedaliero-Universitaria S.Luigi Gonzaga
Orbassano, 10043
- Recruiting
Azienda Ospedaliera S.Giovanni Addolorata
Roma, 00184
- Recruiting
Istituto Nazionale Tumori Regina Elena IRCCS
Roma
- Recruiting
Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)
Varese, 21100
- Recruiting
Centro Ricerche Cliniche di Verona s.r.l.
Verona
Greece10 sites, 10 recruiting
- Recruiting
General Hospital of Athens of Chest Diseases "SOTIRIA"
Athens, 11527
- Recruiting
'Henry Dynant' Hospital Center
Athens
- Recruiting
National and Kapodistrian University of Athens (Nkua)-University General Hospital Attikon
Athens
- Recruiting
University General Hospital of Larissa
Larissa
- Recruiting
Metropolitan Hospital
Neo Faliro, 18547
- Recruiting
St Luke's Hospital
Panórama, 55236
- Recruiting
University General Hospital of Patras
Pátrai
- Recruiting
Special Anticancer Hospital of Piraeus 'Metaxa'
Piraeus
- Recruiting
General Hospital Papageorgiou
Thessaloniki, 57010
- Recruiting
Interbalkan Hospital of Thessaloniki
Thessaloniki
Romania9 sites, 9 recruiting
- Recruiting
Delta Health Care S.R.L
Bucharest, 14142
- Recruiting
Colentina Hospital
Bucharest
- Recruiting
Memorial Healthcare International S R L
Bucharest
- Recruiting
Institutul Oncologic
Cluj-Napoca, 400015
- Recruiting
Spitalul Clinic Militar de Urgenta Dr. "Constantin Papilian" Cluj-Napoca
Cluj-Napoca, 400132
- Recruiting
Centrul de Oncologie Sfantul Nectarie Craiova
Craiova, 200347
- Recruiting
Institutul Regional de Oncologie Lasi
Lasi, 700483
- Recruiting
S.C R.T.C Radiology Therapeutic Center S.R.L
Otopeni
- Recruiting
Spitalul Municipal Ploiesti
Ploieşti
South Korea9 sites, 9 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
- Recruiting
National Cancer Center
Goyang-si, 10408
- Recruiting
Gyeongsang National University Hospital
Jinju
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam, 13496
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
- Recruiting
Asan Medical Center
Seoul
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247
Taiwan9 sites, 9 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
- Recruiting
Taichung Veterans General Hospital
Taichung
- Recruiting
Chi Mei Hospital, Liouying
Tainan
- Recruiting
National Cheng Kung University Hospital
Tainan
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei
- Recruiting
Taipei Veterans General Hospital
Taipei
- Recruiting
Tri-Service General Hospital
Taipei
- Recruiting
Chang Gung Memorial Hospital,Linkou
Taoyuan City
Chile6 sites, 6 recruiting
- Recruiting
Biocenter
Concepción
- Recruiting
Orlandi Oncologia
Santiago, 7500713
- Recruiting
Centro de Oncologia de Precision
Santiago, 7560908
- Recruiting
Hospital Clinico Universidad de Chile
Santiago, 8380456
- Recruiting
Centro de Investigacion Clinica Bradford Hill
Santiago, 8420383
- Recruiting
Clinica Redsalud Vitacura
Santiago
India6 sites, 6 recruiting
- Recruiting
Mazumdar Shaw Medical Center
Bangalore
- Recruiting
All India Institute of Medical Sciences
Bhubaneswar, 751019
- Recruiting
Narayana Superspeciality Hospital
Howrah
- Recruiting
Yenepoya Medical College Hospital
Mangalore
- Recruiting
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004
- Recruiting
Nirmal Hospital Private Limited
Surat
Thailand6 sites, 6 recruiting
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Phramongkutklao Hospital
Bangkok
- Recruiting
Vajira Hospital
Dusit, 10300
- Recruiting
Songklanagarind Hospital
Hat Yai, 90110
- Recruiting
Chulabhorn Hospital
Laksi
- Recruiting
Rajavithi Hospital
Rajathevee
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Medical Park Seyhan Hospital
Adana
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Research and Training Hospital, Clinical Research Center
Ankara, 06200
- Recruiting
Gulhane Training and Research Hospital
Ankara, 6010
- Recruiting
Hacettepe University Medical Faculty
Ankara, 6100
- Recruiting
Medipol University Medical Faculty
Istanbul, 34147
- Recruiting
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34722
Belgium5 sites, 5 recruiting
- Recruiting
UZA
Edegem, 2650
- Recruiting
Grand Hôpital de Charleroi-Les Viviers
Gilly, 6060
- Recruiting
Chu Helora Hospital La Louvière Site Jolimont
La Louvière, 7100
- Recruiting
Chu de Liăge
Liège
- Recruiting
CHU Helora-Hospital de Mons
Mons
Germany5 sites, 5 recruiting
- Recruiting
Universitatsmedizin Mainz
Essen, 60590
- Recruiting
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
- Recruiting
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
Giessen, 35392
- Recruiting
Universitaetsmedizin Mannheim
Manheim
- Recruiting
Universtitaetsklinikum Essen
Nordrhein Westfalen
Hong Kong4 sites, 4 recruiting
- Recruiting
Queen Elizabeth Hospital
Hong Kong
- Recruiting
The University of Hong Kong
Hong Kong
- Recruiting
The Chinese University of Hong Kong
Shatin
- Recruiting
Gleneagles Hospital Hong Kong
Wong Chuk Hang
Malaysia4 sites, 4 recruiting
- Recruiting
Gleneagles Hospital Penang
Jalan Pangkor, 10050
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur
- Recruiting
Hospital Tengku Ampuan Afzan
Kuantan
- Recruiting
Beacon Hospital Sdn Bhd
Petaling Jaya
Portugal4 sites, 4 recruiting
- Recruiting
Hospital da Luz
Lisbon, 1500-650
- Recruiting
Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido Valente
Lisbon
- Recruiting
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto, 4099-001
- Recruiting
Hospital CUF Porto
Porto, 4100-180
United Kingdom4 sites, 4 recruiting
- Recruiting
Eastbourne District General Hospital
Eastbourne, BN21 2UD
- Recruiting
Charing Cross Hospital
London
- Recruiting
Altnagelvin Area Hospital
Londonderry, BT47 6SB
- Recruiting
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB
Mexico1 site, 1 recruiting
- Recruiting
Clinstile, S.A. de C.V.
Mexico City, 06700
Poland1 site, 1 recruiting
- Recruiting
Wojewodzki Szpital Im. SW. Ojca Pio W Przemyslu
Rzeszów
About this study
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)
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Trastuzumab Deruxtecan, pembrolizumab, Pemetrexed, Platinum Chemotherapy
- Keywords
- DESTINY, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab DeruxtecanDrug
Also called T-DXd, ENHERTU®, DS-8201a
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
pembrolizumabDrug
Also called KEYTRUDA®
pembrolizumab will be administered at a dose of 200 mg IV Q3W
PemetrexedDrug
Pemetrexed will be administered at a dose of 500 mg/m^2 IV Q3W
Platinum ChemotherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A: T-DXd + Pembrolizumab | Experimental | Participants will receive T-DXd plus pembrolizumab Receives: Drug: Trastuzumab Deruxtecan; Drug: pembrolizumab |
| Arm B: Pemetrexed + Platinum Chemotherapy + Pembrolizumab | Active comparator | Participants will receive Pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab Receives: Drug: pembrolizumab; Drug: Pemetrexed; Drug: Platinum Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival by Blinded Independent Central Review
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.
Measured: From date of randomization to the date of radiographic disease progression or death due to any cause, up to approximately 54 months
Secondary outcomes (1)
Overall Survival
OS is defined as the time interval from the date of randomization to the date of death due to any cause.
Measured: From date of randomization to the date of death due to any cause, up to approximately 85 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start24 Oct 2025
- Primary completion24 Apr 2030 (estimated)
- Study completion24 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899126
- Sponsor's protocol ID
- DS8201-793
- Other IDs
- 2024-515658-26-00, KEYNOTE-G23, MK-3475-G23
- Acronym
- DESTINY-Lung06
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Publications
Janne PA, Zhou CC, Smit EF, Felip E, Blumenschein G Jr, Goto K, William WN Jr, Abe C, Lin J, Cheng CY, Pereira K. DESTINY-Lung06: trastuzumab deruxtecan and pembrolizumab as first-line treatment for HER2-overexpressing, PD-L1 TPS <50% NSCLC. Future Oncol. 2026 Sep 2:1-9. doi: 10.1080/14796694.2026.2724696. Online ahead of print.
PubMed 42682104