Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
DESTINY-Lung06
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)
4 other identifiers
interventional
686
23 countries
237
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Oct 2025
Typical duration for phase_3 nonsmall-cell-lung-cancer
237 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 24, 2032
July 21, 2026
July 1, 2026
4.5 years
March 21, 2025
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
From date of randomization to the date of death due to any cause, up to approximately 85 months
Study Arms (2)
Arm A: T-DXd + Pembrolizumab
EXPERIMENTALParticipants will receive T-DXd plus pembrolizumab
Arm B: Pemetrexed + Platinum Chemotherapy + Pembrolizumab
ACTIVE COMPARATORParticipants will receive Pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab
Interventions
Pemetrexed will be administered at a dose of 500 mg/m\^2 IV Q3W
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (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
pembrolizumab will be administered at a dose of 200 mg IV Q3W
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLCcollaborator
- Daiichi Sankyolead
Study Sites (237)
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, 99508, United States
Orange Coast Memorial Medical Center Fountain Valley
Fountain Valley, California, 97208, United States
California Research Institute
Los Angeles, California, 90027, United States
Los Angeles Cancer Network (LACN)
Los Angeles, California, 91204, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Lynn Cancer Institute Center
Boca Raton, Florida, 33486, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, 33763, United States
BRCR Global Plantation
Plantation, Florida, 33321, United States
Cleveland Clinic Florida - Weston
Weston, Florida, 33331, United States
Piedmont Cancer Institute OneOncology
Atlanta, Georgia, 30318, United States
The Queens Medical Center
Honolulu, Hawaii, 96813-2402, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02216, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Clinical Research Alliance
Westbury, New York, 11590, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374, United States
Carolina Cancer Research Center
Wilson, North Carolina, 27893, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
St. Charles Health System
Bend, Oregon, 97701, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Lumi Research
Kingwood, Texas, 77339, United States
Summit Cancer Treatment Center
Spokane, Washington, 99208, United States
CINME - Centro De Investigaciones Metabolicas
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires, Argentina
Instituto de Investigaciones Metabolicas (IDIM)
Buenos Aires, Argentina
Centro de Investigaciones Medicas y Desarrollo LC SRL (LC Investigacion)
Ciudad Autonoma Buenos Aires, 1113, Argentina
Instituto de Investigaciones Clinicas Cordoba S.A.
Córdoba, 5000, Argentina
Centro de Investigacion Pergamino SA
Pergamino, Argentina
Hospital Universitario Austral
Pilar, Argentina
Sanatorio Britanico S.A.
Rosario, 2000, Argentina
Instituto de Oncologia de Rosario
Rosario, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Argentina
Sanatorio Parque S.A.
Rosario, Argentina
Instituto San Marcos
San Juan, Argentina
Grand Hôpital de Charleroi-Les Viviers
Gilly, 6060, Belgium
Chu Helora Hospital La Louvière Site Jolimont
La Louvière, 7100, Belgium
Chu de Liăge
Liège, Belgium
CHU Helora-Hospital de Mons
Mons, Belgium
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, 14784-400, Brazil
Centro de Pesquisas Clinica Reichow
Blumenau, 89010-340, Brazil
CIONC-Centro Integrado de Oncologia de Curitiba
Curitiba, 80810-050, Brazil
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, 60336-045, Brazil
Liga Norte-Rio-Grandense Contra o Câncer
Natal, 59075-740, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90035-170, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, 90619-000, Brazil
Hospital Nossa Senhora Da Conceição
Porto Alegre, Brazil
Centro de Tratamento Oncologico (CTO)
Ribeirão Preto, 14026-596, Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, 14051-140, Brazil
Oncoclínicas Rio de Janeiro
Rio de Janeiro, 20230-130, Brazil
Instituto Dâor Pesquisa E Ensino - Rio de Janeiro
Rio de Janeiro, Brazil
Obras Sociais Irmã Dulce - Hospital Santo Antônio
Salvador, 40.414-120, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, 09060-870, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, 15090-000, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, Brazil
Centro Paulista de Oncologia S A
Vila Olímpia, Brazil
Biocenter
Concepción, Chile
Orlandi Oncologia
Santiago, 7500713, Chile
Centro de Oncologia de Precision
Santiago, 7560908, Chile
Hospital Clinico Universidad de Chile
Santiago, 8380456, Chile
Centro de Investigacion Clinica Bradford Hill
Santiago, 8420383, Chile
Clinica Redsalud Vitacura
Santiago, Chile
Beijing Cancer Hospital
Beijing, 100142, China
China-Japan Friendship hospital
Beijing, China
Jilin Cancer Hospital
Changchun, 130000, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Nanfang Hospital of Southern Medical University
Guangzhou, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Hospital
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
Hong Kong Integrated Oncology Centre
Hong Kong, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Hong Kong United Oncology Centre
Jordan, China
Linyi Cancer Hospital
Linyi, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
The Second People's Hospital of Neijiang
Neijiang, China
Shanghai East Hospital
Shanghai, China
The First Hospital of China Medical University
Shenyang, 110001, China
Liaoning Cancer Hospital & Institute
Shenyang, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Tianjin Medical University General Hospital
Tianjin, China
Hubei Cancer Hospital
Wuhan, 430079, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Xiangyang Central Hospital
Xiangyang, China
Henan Cancer Hospital
Zhengzhou, 450003, China
CHU Angers - Hôpital Larrey
Angers, 49933, France
Institut Bergonié
Bordeaux, France
Hăpital Ambroise Pară
Boulogne-Billancourt, France
Hospices Civils de Lyon
Bron, 69677, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Centre Georges Francois Leclerc
Dijon, 21079, France
Hopital Albert Calmette - CHU Lille
Lille, France
Centre Leon Berard
Lyon, France
Assistance Publique-Hôpitaux de Marseille
Marseille, 13915, France
Clinique Clementville
Montpellier, 34070, France
Hăpital Privă Du Confluent
Nantes, France
Hopital Bichat - Claude Bernard
Paris, 75018, France
Chu Nantes - Hăpital Guillaume Et Renă Laă Nnec
Saint-Herblain, France
Institut de Cancerologie de L'Ouest
Saint-Herblain, France
Hăpital Foch
Suresnes, France
Hopital Larrey
Toulouse, 31059, France
Universitatsmedizin Mainz
Essen, 60590, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Universitaetsmedizin Mannheim
Manheim, Germany
Universtitaetsklinikum Essen
Nordrhein Westfalen, Germany
General Hospital of Athens of Chest Diseases "SOTIRIA"
Athens, 11527, Greece
'Henry Dynant' Hospital Center
Athens, Greece
National and Kapodistrian University of Athens (Nkua)-University General Hospital Attikon
Athens, Greece
University General Hospital of Larissa
Larissa, Greece
Metropolitan Hospital
Neo Faliro, 18547, Greece
St Luke's Hospital
Panórama, 55236, Greece
University General Hospital of Patras
Pátrai, Greece
Special Anticancer Hospital of Piraeus 'Metaxa'
Piraeus, Greece
General Hospital Papageorgiou
Thessaloniki, 57010, Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, Greece
Queen Elizabeth Hospital
Hong Kong, Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
The Chinese University of Hong Kong
Shatin, Hong Kong
Gleneagles Hospital Hong Kong
Wong Chuk Hang, Hong Kong
Mazumdar Shaw Medical Center
Bangalore, India
All India Institute of Medical Sciences
Bhubaneswar, 751019, India
Narayana Superspeciality Hospital
Howrah, India
Yenepoya Medical College Hospital
Mangalore, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Nirmal Hospital Private Limited
Surat, India
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Irccs
Bologna, Italy
Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
Candiolo, Italy
Ospedale Santa Croce
Fano, 61032, Italy
Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
Genova, Italy
Presidio Ospedaliero Di Livorno
Livorno, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Humanitas Istituto Clinico Catanese
Misterbianco, 95045, Italy
Azienda Ospedaliero-Universitaria S.Luigi Gonzaga
Orbassano, 10043, Italy
Azienda Ospedaliera S.Giovanni Addolorata
Roma, 00184, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Roma, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, Italy
Saitama Medical University International Medical Center
Hidaka-shi, Japan
Kansai Medical University Hospital
Hirakata-shi, Japan
Hirosaki University Hospital
Hirosaki-shi, 036-8563, Japan
National Cancer Center Hospital East
Kashiwa-shi, 277-8577, Japan
St. Marianna University Hospital
Kawasaki-shi, 220-0011, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Japan
Kurume University Hospital
Kurume-shi, 810-0001, Japan
Matsusaka Municipal Hospital
Matsusaka-shi, Japan
NHO Okayama Medical Center
Okayama, 700-0815, Japan
Osaka City General Hospital
Osaka, 533-0033, Japan
Osaka International Cancer Institute
Osaka, 541-0045, Japan
Toho University Omori Medical Center
Ōta-ku, Japan
NHO Kinki-Chuo Chest Medical Center
Sakaishi, Japan
Keijinkai Teine Keijinkai Hospital
Sapporo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, 220-0004, Japan
Shizuoka Cancer Center
Sunto-gun, Japan
Ehime University Hospital
Toon-shi, 162-0821, Japan
Fujita Health University Hospital
Toyoake-shi, 470-1192, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Kanagawa Cancer Center
Yokohama, Japan
Tottori University Hospital
Yonago-shi, Japan
Gleneagles Hospital Penang
Jalan Pangkor, 10050, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, Malaysia
Wojewodzki Szpital Im. SW. Ojca Pio W Przemyslu
Rzeszów, Poland
Hospital da Luz
Lisbon, 1500-650, Portugal
Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido Valente
Lisbon, Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto, 4099-001, Portugal
Hospital CUF Porto
Porto, 4100-180, Portugal
Delta Health Care S.R.L
Bucharest, 14142, Romania
Colentina Hospital
Bucharest, Romania
Memorial Healthcare International S R L
Bucharest, Romania
Institutul Oncologic
Cluj-Napoca, 400015, Romania
Spitalul Clinic Militar de Urgenta Dr. "Constantin Papilian" Cluj-Napoca
Cluj-Napoca, 400132, Romania
Centrul de Oncologie Sfantul Nectarie Craiova
Craiova, 200347, Romania
Institutul Regional de Oncologie Lasi
Lasi, 700483, Romania
S.C R.T.C Radiology Therapeutic Center S.R.L
Otopeni, Romania
Spitalul Municipal Ploiesti
Ploieşti, Romania
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
CHA Bundang Medical Center, CHA University
Seongnam, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 8908, Spain
Hospital Universitari Dexeus
Barcelona, Spain
Hospital Universitari Vall d'Hebron - VHIO
Barcelona, Spain
Hospital Provincial de Castellon
Castellion, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Clinico San Carlos
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, 41014, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi Mei Hospital, Liouying
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Cancer Center
Taipei, 106, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan City, Taiwan
Siriraj Hospital
Bangkok, 10700, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Vajira Hospital
Dusit, 10300, Thailand
Songklanagarind Hospital
Hat Yai, 90110, Thailand
Chulabhorn Hospital
Laksi, Thailand
Rajavithi Hospital
Rajathevee, Thailand
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 6010, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 6100, Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, 34147, Turkey (Türkiye)
Eastbourne District General Hospital
Eastbourne, BN21 2UD, United Kingdom
Charing Cross Hospital
London, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2025
First Posted
March 27, 2025
Study Start
October 24, 2025
Primary Completion (Estimated)
April 24, 2030
Study Completion (Estimated)
November 24, 2032
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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/