Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)
6 other identifiers
interventional
1,170
28 countries
248
Brief Summary
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2023
Longer than P75 for phase_3
248 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
September 22, 2022
CompletedFirst Posted
Study publicly available on registry
September 27, 2022
CompletedStudy Start
First participant enrolled
January 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 11, 2029
March 25, 2026
March 1, 2026
6.3 years
September 22, 2022
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Overall Survival in All Randomized Participants
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
Overall Survival in All Randomized Participants who are TROP2 NMR positive
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
Secondary Outcomes (11)
Objective Response Rate by Blinded Independent Central Review in All Randomized Participants
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Objective Response Rate by Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Progression-free Survival by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Objective Response Rate by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Duration of Response by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive
From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months
- +6 more secondary outcomes
Study Arms (3)
Dato-DXd + Pembrolizumab + Platinum Chemotherapy
EXPERIMENTALParticipants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]).
Dato-DXd + Pembrolizumab
EXPERIMENTALParticipants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab.
Pembrolizumab + Pemetrexed + Platinum Chemotherapy
ACTIVE COMPARATORParticipants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m\^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]).
Interventions
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Eligibility Criteria
You may qualify if:
- Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is \>18 years old).
- Has tumor with PD-L1 TPS \<50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of 6 slides). PD-L1 expression results available at the same central laboratory from screening for the purpose of entry into another Dato-DXd study may be used for tissue screening purposes in this study as long as the subject has not been randomized/enrolled in the other study.
- Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron sections or block equivalent) for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers. This tissue requirement is in addition to the tissue required for PD-L1 testing for tissue screening purposes. If a documented law or regulation prohibits (or does not approve) sample collection, then such sample will not be collected, and the subject is still eligible for the study.
You may not qualify if:
- Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days before randomization.
- Has received prior systemic treatment for advanced/metastatic NSCLC.
- Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting (for NSCLC):
- Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I
- TROP2-targeted therapy
- Any anti-PD-1, anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
- Any other ICIs Subjects who received adjuvant or neoadjuvant therapy other than those listed above are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced or metastatic disease.
- Has received a live vaccine within 30 days prior to the first dose of study treatment.
- Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. For any subject receiving an approved severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine, please follow the vaccine label and/or local guidance. The vaccine manufacturer and the date of administration should be recorded on the electronic case report form (Concomitant Medications page), as should any AEs relating to the vaccine (including hypersensitivity or allergies). Note: Any licensed SARS-CoV2 vaccine (including those authorized for emergency use) in a particular country is allowed in the study as long as the vaccine is an mRNA vaccine, replication-incompetent adenoviral vaccine, or inactivated vaccine. Such vaccines will be treated just as any other concomitant therapy.
- Investigational vaccines (ie, those not licensed or authorized for emergency use) are not allowed.
- Has spinal cord compression or clinically active untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 2 weeks by repeat imaging (Note: Repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 7 days before the first dose of study drug. Note: A contrasted computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of the brain at baseline (MRI with contrast preferred) is required for all subjects. For those subjects in whom CNS metastases are first discovered at the time of screening, the treating investigator must delay of study treatment to document stability of CNS metastases with repeat imaging at least 2 weeks later (in which case, repeat of all screening activity may be required).
- Has uncontrolled or significant cardiovascular disease not controlled by maximal medical therapy, including:
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval \>470 msec regardless of sex (based on the 12-lead electrocardiogram \[ECG\] performed at screening).
- Myocardial infarction within 6 months prior to Cycle 1 Day 1.
- History of a serious cardiac arrhythmia requiring treatment
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- AstraZenecacollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (254)
Southern Cancer Center Pc
Daphne, Alabama, 36526, United States
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Arizona Oncology Associates, Pc - Nahoa
Prescott Valley, Arizona, 86314, United States
Hoag Memorial Hospital Prebyterian
Newport Beach, California, 92663, United States
Compassionate Cancer Care Medical Group
Riverside, California, 92501, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Ronald Reagan UCLA Medical Center
Santa Monica, California, 90404, United States
UCHealth Memorial Hospital
Colorado Springs, Colorado, 80909, United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901, United States
Cancer Specialist of North Florida
Jacksonville, Florida, 32256, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901, United States
Woodlands Medical Specialists, Pa
Pensacola, Florida, 32503, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, 33705, United States
Emory University - Winship Cancer Institute Wci
Atlanta, Georgia, 30322-1013, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
American Oncology Partners of Maryland
Bethesda, Maryland, 20817, United States
Maryland Oncology Heamtology P.A.
Columbia, Maryland, 21044, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute; Inv Drg Svc Pharm
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute At St. Elizabeth'S Medical Center
Brighton, Massachusetts, 02135, United States
Dana Farber Brigham Cancer Center
Foxborough, Massachusetts, 02035, United States
Dana Farber At Milford Regional Cancer Center
Milford, Massachusetts, 01757, United States
Dana Farber/Bwcc in Affiliation With South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Regional Cancer Care Associates LLC
Hackensack, New Jersey, 07601, United States
North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists- New Hyde Park
New Hyde Park, New York, 11042, United States
North Shore Hematology Oncology Associates
Patchogue, New York, 11772, United States
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
Port Jefferson Station, New York, 11776, United States
North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists - Bronx
The Bronx, New York, 10469, United States
Texas Oncology, P.A.
McAllen, Texas, 78503, United States
Ut Health San Antonio
San Antonio, Texas, 78229, United States
Texas Oncology, P.A.
Sugar Land, Texas, 77479, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Utah Cancer Specialists IHO Corp
Salt Lake City, Utah, 84106, United States
Providence Regional Cancer System
Lacey, Washington, 98503, United States
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
Centro de Investigaciones Medicas y Desarrollo LC SRL
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Fundacion CENIT para la investigacion en Neurociencias
Ciudad Autonoma de Buenos Aire, 1125, Argentina
Hospital de La Comunidad
Mar del Plata, 7600, Argentina
Centro de Investigacion Pergamino Sa
Pergamino, B2700, Argentina
Instituto de Oncologia de Rosario
Rosario, 2000DSK, Argentina
Sanatorio Parque
Rosario, S2000DSV, Argentina
Sanatorio Britanico
Rosario, Argentina
Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan
San Juan, 5400, Argentina
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma, 8500, Argentina
CRSA/ St Andrews Hospital
Adelaide, 5000, Australia
Flinders Medical Centre (Fmc)
Bedford Park, 5042, Australia
PSEHOG (Peninsula and South Eastern Haematology and Oncology Group)
Frankston, 3199, Australia
St George Public Hospital
Kogarah, 2217, Australia
Southern Medical Day Care Centre
Wollongong, 2500, Australia
Princess Alexandra Hospital
Woolloongabba, QLD 4102, Australia
Landeskrankenhaus Feldkirch
Feldkirch, 6800, Austria
Klinikum Klagenfurt Pulmologie
Klagenfurt, 9020, Austria
Karl Landsteiner Institut Fã¼R Lungenforschung Und Pneumologische Onkologie C/O Klinik Floridsdorf
Vienna, 1210, Austria
Az Maria Middelares - Campus Maria Middelares
Ghent, 9000, Belgium
Centre hospitalier Jolimont-Lobbes
Haine-Saint-Paul, Belgium
Jessa Hospital
Hasselt, 3500, Belgium
Cliniques Saint Pierre Ottignies (CSPO)
Ottignies, Belgium
Az Nikolaas
Sint-Niklaas, 9100, Belgium
Personal Oncologia de Precisao - Cenantron
Belo Horizonte, 30130 090, Brazil
Fundaco Universidade de Caxias Do Sul- Instituto de Pesquisas Em Saude Ips-Ucs
Caxias do Sul, 95070-560, Brazil
Hospital Erasto Gaertner
Curitiba, 81520-060, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, 98700-000, Brazil
Clínica de Neoplasias Litoral Ltda
ItajaĂ-, 88301-220, Brazil
Clnica Lacks
Pelotas, 96020-080, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Instituto Nacional de Căncer - Inca
Rio de Janeiro, 20231-050, Brazil
Centro de Estudos E Pesquisa de Hematologia E Oncologia - Cepho
Santo André, 09060-870, Brazil
Instituto de Ensino E Pesquisa Sao Lucas
São Paulo, 01236-030, Brazil
Instituto Do Cancer Brasil - Unidade Taubate
Taubaté, 12030-200, Brazil
CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus
Québec, G1J 1Z4, Canada
ONCOVIDA
Santiago, 7500000, Chile
Centro de Estudios Clinicos Saga Spa
Santiago, 7500653, Chile
Orlandi Oncologia
Santiago, 7500713, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile
Centro de Investigaciones Clinicas Vina Del Mar
ViĂąa Del Mar, 254-0488, Chile
Oncocentro Apys
Viña del Mar, Chile
Peking University Peoples Hospital
Beijing, 100044, China
Peking University Cancer Hospital Beijing Cancer Hospital Beijing Institute For Cancer Research
Beijing Sheng, 100142, China
Cangzhou Peoples Hospital
Cangzhou, 061000, China
First Affiliated Hospital of Medical College of Jilin University
Changchun, 130000, China
Jilin Cancer Hospital
Changchun, 130000, China
Hunan Cancer Hospital
Changsha, 410011, China
University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute SIC
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fujian Medical University - Union Hospital Foochow Christian Union Hospital
Fuzhou, 350001, China
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, 510080, China
Affiliated Cancer Hospital and Insititute of Guangzhou Medical University
Guangzhou, 510095, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 310000, China
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, 310003, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
An Hui Cancer Hospital
Hefei, China
Inner Mongolia Medical University- the Affiliated Hospital
Hohhot, 010050, China
Jiamusi Cancer Hospital
Jiamusi, 154007, China
Linyi Cancer Hospital
Linyi, 276000, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Zhongda Hospital, Southeast University
Nanjing, 210009, China
Shanghai Chest Hospital
Shanghai, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Liaoning Cancer Hospital & Institute
Shenyang, 110042, China
The First Affiliated Hosptial of Xinjiang Medical University
Ürümqi, 830000, China
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
The First Affiliate Hospital of Xi'An Jiaotong University
Xi'an, 710061, China
Xiangyang Central Hospital
Xianyang, 441021, China
Henan Cancer Hospital
Zhengzhou, 450003, China
FN Brno Klinika Nemoci Plicnich a TBC
Brno, 63500, Czechia
Fakultni nemocnice Olomouc FNOL
Olomouc, 779 00, Czechia
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, France
Hopital Jean Minjoz - CHU de Besancon
Besançon, 25000, France
Chu de Bordeaux - Hopital Saint Andre
Bordeaux, 33075, France
Centre Hospitalier Universitaire, CHU, de Poitiers
France, 86021, France
Hopital Lyon Sud
Lyon, 69003, France
Centre Leon Berard
Lyon, 69008, France
Institut Paoli Calmettes
Marseille, 13009, France
Aphm - Hopital Nord
Marseille, 13015, France
Chu de Montpellier
Montpellier, 34295, France
Chu de Nantes
Nantes, 44000, France
Hopital Prive Du Confluent
Nantes, 44277, France
Institut Curie
Paris, 75005, France
Tenon Hospital
Paris, 75020, France
CHU de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Hôpital Foch
Suresnes, 92150, France
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Klinikum Chemnitz
Chemnitz, 9116, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Klinikum Esslingen Gmbh
Esslingen am Neckar, 73730, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
University Hospital Giessen, ZIM IV
Giessen, Germany
External pharmacy Fortuna Herstellung GmbH of main site Universitaetsmedizin Mannheim
Mannheim, Germany
Ludwig-Maximilians University Hospital of Munich
Munich, 80336, Germany
University Hospital Mănster
Münster, 48149, Germany
Sotiria General Hospital of Chest Diseases
Athens, 11527, Greece
Metropolitan Hospital - Athens
Athens, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
University Hospital of Ioannina Uhi
Ioannina, 45500, Greece
Metropolitan Hospital
Neo Faliro, 18547, Greece
Olympion Hospital
Pátrai, 26443, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, 546 45, Greece
St. Luke's Hospital
Thessaloniki, Greece
Bioclinic Thessaloniki (Galinos Clinic)
Thessalonki, 54622, Greece
Tuen Mun Hospital
Hong Kong, 999077, Hong Kong
Prince of Wales Hospital / The Chinese University of Hong Kong
Hong Kong, 99999, Hong Kong
Queen Mary Hospital
Pok Fu Lam, 999077, Hong Kong
National Koranyi Institute For Pulmonology
Budapest, 1121, Hungary
Veszprem Megyei Tudogyogyintezet Farkasgyepu
Farkasgyepű, 8582, Hungary
Bkmk Hospital
KecskemĂŠt, 6000, Hungary
Fejer Megyei Szent Gyorgy Korhaz Pulmonologiai Osztaly
Székesfehérvár, 8000, Hungary
Hetenyi G Korhaz, Onkologiai Kozpont
Szolnok, 5007, Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, Hungary
Istituto Di Candiolo Irccs
Candiolo, 10060, Italy
Ospedale San Luca
Lucca, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
IFO Regina Elena
Rome, Italy
Ospedale S. Maria Della Misericordia
Udine, 33100, Italy
Asst Sette Laghi
Varese, 21100, Italy
Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Roma Crc - Centro Ricerche Clinich
Verona, 37134, Italy
NHO Shikoku Cancer Center
Ehime, Japan
Kurume University Hospital
Fukoka, 830-0011, Japan
Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-0054, Japan
Teine Keijinkai Hospital
Hokkaido, 006-0811, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
Kanazawa University Hospital
Ishikawa, 920-8641, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Kitasato University hospital
Kanagawa, 252-0375, Japan
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Kumamoto, 861-4193, Japan
University Hospital Kyoto Prefectual University of Medicine
Kyoto, 602-8566, Japan
Matsusaka Municipal Hospital
Mie, 515-8544, Japan
Sendai Kousei Hospital
Miyagi, 981-0914, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute
Osaka, 540-0008, Japan
Osaka Toneyama Medical Center
Osaka, 560-8552, Japan
Kansai Medical University Hospital
Osaka, 573-1191, Japan
NHO Kinki-Chuo Chest Medical Center
Osaka, 591-8555, Japan
Dokkyo Medical University Hospital
Tochigi, 321-0293, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, 113-0021, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-0063, Japan
Toho University Omori Medical Center
Tokyo, 143-8540, Japan
Iwakuni Clinical Center
Yamaguchi, 740-8510, Japan
Yamaguchi-Ube Medical Center
Yamaguchi, 755-0241, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506, Japan
Cryptex Investigacion Clinica Sa de Cv
Cuauhtémoc, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico
Health Pharma Professional Research S.A de C.V.
Mexico City, Mexico
Instituto Nacional de Cancerologia
Mexico City, Mexico
Centro de Investigacion Clinica de Oaxaca CICLO
Oaxaca City, Mexico
Jeroen Bosch Ziekenhuis Jbz
's-Hertogenbosch, 5200 ME, Netherlands
Amphia Ziekenhuis
Breda, 4819 EV, Netherlands
Leiden University Medical Center
Leiden, 2333ZA, Netherlands
II Klinika Chorob Pluc i Gruzlicy
Bialystok, 15-540, Poland
Centrum Terapii Wspolczesnej
Lodz, 90-338, Poland
Instytut Centrum Zdrowia Matki Polki (Iczmp)
Lodz, 93-338, Poland
SPSK4, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954, Poland
Med Polonia Sp. Z O.O.
Poznan, 60-693, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02-778, Poland
Fundacao Champalimaud
Lisbon, 1400-038, Portugal
IPO Porto Francisco Gentil, E.P.E.
Porto, 4150-001, Portugal
Hospital CUF Porto
Porto, Portugal
Institute of Oncology Prof. Dr. Ion Chiricuta
Cluj-Napoca, 400015, Romania
Onco Clinic Consult Sa
Craiova, 200094, Romania
Centrul de Oncologie Sfantu Nectarie
Craiova, 200745, Romania
SC Oncomed SRL
Jud Timis, Romania
Oncocenter Oncologie Clinica S.R.L
Timișoara, 300166, Romania
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Samsung Medical Center
Gangnam-Gu, 6351, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Gyeongsang National University Hospital
Jinju-si Gyeongsangnam-do, 52727, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Yonsei University Health System - Severance Hospital
Seoul, 3722, South Korea
The Catholic Univ. of Korea, Seoul St. Marys Hospital
Seoul, 6591, South Korea
Vall Hebron University Hospital
Barcelona, 08035, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, 8036, Spain
Hospital Universitario Arnau de Vilanova
Lleida, 25198, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Regional Universitario Malaga
Málaga, 29011, Spain
CHUO
Ourense, 32005, Spain
Hosp Univ Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Hospital Universitario y Politecnico de La Fe
Valenica, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Kantonsspital Baselland
Liestal, 4410, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
Spital Sts Ag
Thun, 3600, Switzerland
Changhua Christian Hospital
Changhua, 500, Taiwan
China Medical University Hospital
Hsia, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10055, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Faculty of Medicine Chulalongkorn University
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Prince of Songkla University PSU - Faculty of Medicine
Hat Yai, 90110, Thailand
Khon Kaen University - Faculty of Medicine-Srinagarind Hospital
Nonthaburi, 40002, Thailand
Baskent University
Adana, 1230, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 6800, Turkey (Türkiye)
Akdeniz University Hospital
Antalya, 7070, Turkey (Türkiye)
Medipol Mega University Hospital
Bağcılar, 34214, Turkey (Türkiye)
Ege Universitesi Gogus Hastaliklari Poliklinigi
Bornova-Izmir, Turkey (Türkiye)
Memorial Ankara Hospital
Cankaya/Ankara, 6520, Turkey (Türkiye)
Istanbul Medeniyet University Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Adana Acibadem Hospital
Seyhan, Turkey (Türkiye)
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
Related Publications (1)
Okamoto I, Kuyama S, Girard N, Lu S, Franke F, Li Z, Danchaivijitr P, Han JY, Sun JM, Sugawara S, Pan E, Ren N, Chen A, Rajagopalan R, Lisberg AE. TROPION-Lung07: Phase III study of Dato-DXd + pembrolizumab +/- platinum-based chemotherapy as 1L therapy for advanced non-small-cell lung cancer. Future Oncol. 2024;20(37):2927-2936. doi: 10.1080/14796694.2024.2409621. Epub 2024 Oct 29.
PMID: 39469838DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2022
First Posted
September 27, 2022
Study Start
January 11, 2023
Primary Completion (Estimated)
May 11, 2029
Study Completion (Estimated)
May 11, 2029
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/