Clinical trial NCT05555732: Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Non Small Cell Lung Cancer
Keywords: Metastatic Non Small Cell Lung Cancer
Advanced Non Small Cell Lung Cancer
Datopotamab Deruxtecan (Dato-DXd)
Pembrolizumab
Pemetrexed
Tropion-Lung07
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
name: Merck Sharp & Dohme LLC
First posted: 2022-09-27
Enrollment: 1170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS \<50% and advanced or metastatic NSCLC without actionable genomic alternations.

Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.

Eligibility criteria: Key Inclusion Criteria:

1. 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.
2. 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).
3. Has tumor with PD-L1 TPS \<50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of six 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.
4. 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.
5. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Subjects who received adjuvant or neoadjuvant therapy other than those listed in the exclusion criteria are eligible if the adjuvant/ neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease and should not have progressed on or within the 6 months of completion.
6. Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days before randomization.

Key Exclusion Criteria:

1. Has received prior systemic treatment for advanced/metastatic NSCLC.
2. Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting (for NSCLC):

   1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I
   2. TROP2-targeted therapy
   3. Any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
   4. 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.
3. 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.
4. 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).
5. Has uncontrolled or significant cardiovascular disease not controlled by maximal medical therapy, including:

   1. 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).
   2. Myocardial infarction within 6 months prior to Cycle 1 Day 1.
   3. History of a serious cardiac arrhythmia requiring treatment
   4. Uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
   5. Left ventricular ejection fraction (LVEF) \<50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization.
   6. New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) at screening. Subjects with a history of Class II to IV CHF prior to screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
   7. Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).
6. Clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli diagnosed within 3 months of Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc) or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), or prior complete pneumonectomy.

Primary outcomes:
measure: Progression-free Survival Based on Blinded Independent Central Review in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
measure: Overall Survival in Participants in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Secondary outcomes:
measure: Objective Response Rate by Blinded Independent Central Review in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
measure: Progression-free Survival by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
measure: Objective Response Rate by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
measure: Duration of Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: 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 29 months
measure: Time to Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization to date of first objective response (CR or PR), up to approximately 29 months
measure: Disease Control Rate by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
measure: Progression-free Survival 2 in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
measure: Time to Deterioration in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE) in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
timeFrame: Up to 57 months
measure: Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
timeFrame: Baseline and up to 57 months
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center Pc
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Prescott Valley
country: United States
facility: Arizona Oncology Associates, Pc - Nahoa
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Prebyterian
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Monica
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialist of North Florida
state: Florida
city: Palm Bay
country: United States
facility: Cancer Care Centers of Brevard, Inc.
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, Pa
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists-North
state: Florida
city: Atlanta
country: United States
facility: Emory University - Winship Cancer Institute Wci
state: Georgia
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Heamtology P.A.
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute; Inv Drg Svc Pharm
state: Massachusetts
city: Brighton
country: United States
facility: Dana Farber Cancer Institute At St. Elizabeth'S Medical Center
state: Massachusetts
city: Foxboro
country: United States
facility: Dana Farber Brigham Cancer Center
state: Massachusetts
city: Milford
country: United States
facility: Dana Farber At Milford Regional Cancer Center
state: Massachusetts
city: South Weymouth
country: United States
facility: Dana Farber/Bwcc in Affiliation With South Shore Hospital
state: Massachusetts
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Hackensack
country: United States
facility: Regional Cancer Care Associates LLC
state: New Jersey
city: Bronx
country: United States
facility: North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists - Bronx
state: New York
city: New Hyde Park
country: United States
facility: North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists- New Hyde Park
state: New York
city: Patchogue
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Port Jefferson Station
country: United States
facility: North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
state: New York
city: McAllen
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Ut Health San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists IHO Corp
state: Utah
city: Lacey
country: United States
facility: Providence Regional Cancer System
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fundacion CENIT para la investigacion en Neurociencias
city: Mar del Plata
country: Argentina
facility: Hospital de La Comunidad
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino Sa
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clinicas. Clinica Viedma S.A.
city: Adelaide
country: Australia
facility: CRSA/ St Andrews Hospital
city: Bedford Park
country: Australia
facility: Flinders Medical Centre (Fmc)
city: Frankston
country: Australia
facility: PSEHOG (Peninsula and South Eastern Haematology and Oncology Group)
city: Kogarah
country: Australia
facility: St George Public Hospital
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt Pulmologie
city: Vienna
country: Austria
facility: Karl Landsteiner Institut Fã¼R Lungenforschung Und Pneumologische Onkologie C/O Klinik Floridsdorf
city: Gent
country: Belgium
facility: Az Maria Middelares - Campus Maria Middelares
city: Haine Saint-Paul
country: Belgium
facility: Centre hospitalier Jolimont-Lobbes
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Ottignies
country: Belgium
facility: Cliniques Saint Pierre Ottignies (CSPO)
city: Sint-Niklaas
country: Belgium
facility: Az Nikolaas
city: Belo Horizonte
country: Brazil
facility: Personal Oncologia de Precisao - Cenantron
city: Caxias do Sul
country: Brazil
facility: Fundaco Universidade de Caxias Do Sul- Instituto de Pesquisas Em Saude Ips-Ucs
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
city: ItajaĂ-
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda
city: Pelotas
country: Brazil
facility: Clnica Lacks
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Că'Ncer - Inca
city: Santo Andre
country: Brazil
facility: Centro de Estudos E Pesquisa de Hematologia E Oncologia - Cepho
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino E Pesquisa Sao Lucas
city: Taubate
country: Brazil
facility: Instituto Do Cancer Brasil - Unidade Taubate
city: Quebec City
country: Canada
facility: CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus
city: Santiago de Chile
country: Chile
facility: Centro de Estudios Clinicos Saga Spa
city: Santiago
country: Chile
facility: ONCOVIDA
city: Santiago
country: Chile
facility: Orlandi Oncologia
city: ViĂąa Del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina Del Mar
city: Beijing Sheng
country: China
facility: Peking University Cancer Hospital Beijing Cancer Hospital Beijing Institute For Cancer Research
city: Beijing
country: China
facility: Peking University Peoples Hospital
city: Cangzhou
country: China
facility: Cangzhou Peoples Hospital
city: Changchun
country: China
facility: First Affiliated Hospital of Medical College of Jilin University
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute SIC
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Medical University - Union Hospital Foochow Christian Union Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat-Sen University
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital and Insititute of Guangzhou Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: Run Run Shaw Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine Zhejiang University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hohhot
country: China
facility: Inner Mongolia Medical University- the Affiliated Hospital
city: Jiamusi
country: China
facility: Jiamusi Cancer Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The First Affiliate Hospital of Xi'An Jiaotong University
city: Xianyang
country: China
facility: Xiangyang Central Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Ürümqi
country: China
facility: The First Affiliated Hosptial of Xinjiang Medical University
city: Brno
country: Czechia
facility: FN Brno Klinika Nemoci Plicnich a TBC
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc FNOL
city: Besancon
country: France
facility: Hopital Jean Minjoz - CHU de Besancon
city: Bordeaux
country: France
facility: Chu de Bordeaux - Hopital Saint Andre
city: France
country: France
facility: Centre Hospitalier Universitaire, CHU, de Poitiers
city: Lyon
country: France
facility: Hopital Lyon Sud
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille Cedex 20
country: France
facility: Aphm - Hopital Nord
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier Cedex 5
country: France
facility: Chu de Montpellier
city: Nantes
country: France
facility: Chu de Nantes
city: Nantes
country: France
facility: Hopital Prive Du Confluent
city: Paris Cedex 05
country: France
facility: Institut Curie
city: Paris
country: France
facility: Tenon Hospital
city: Rennes
country: France
facility: CHU de Rennes - Hopital Pontchaillou
city: Suresnes
country: France
facility: Hôpital Foch
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Esslingen
country: Germany
facility: Klinikum Esslingen Gmbh
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Giessen
country: Germany
facility: University Hospital Giessen, ZIM IV
city: Mannheim
country: Germany
facility: External pharmacy Fortuna Herstellung GmbH of main site Universitaetsmedizin Mannheim
city: Muenster
country: Germany
facility: University Hospital Mă Nster
city: Munich
country: Germany
facility: Ludwig-Maximilians University Hospital of Munich
city: Athens
country: Greece
facility: Sotiria General Hospital of Chest Diseases
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: University Hospital of Ioannina Uhi
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital
city: Patras
country: Greece
facility: Olympion Hospital
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Thessalonki
country: Greece
facility: Bioclinic Thessaloniki (Galinos Clinic)
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital / The Chinese University of Hong Kong
city: Pok Fu Lam
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: National Koranyi Institute For Pulmonology
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet Farkasgyepu
city: KecskemĂŠt
country: Hungary
facility: Bkmk Hospital
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz Pulmonologiai Osztaly
city: Szolnok
country: Hungary
facility: Hetenyi G Korhaz, Onkologiai Kozpont
city: Candiolo
country: Italy
facility: Istituto Di Candiolo Irccs
city: Lucca
country: Italy
facility: Ospedale San Luca
city: Orbassano
country: Italy
facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga
city: Rome
country: Italy
facility: IFO Regina Elena
city: Udine
country: Italy
facility: Ospedale S. Maria Della Misericordia
city: Varese
country: Italy
facility: Asst Sette Laghi
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Roma Crc - Centro Ricerche Clinich
city: Ehime
country: Japan
facility: NHO Shikoku Cancer Center
city: Fukoka
country: Japan
facility: Kurume University Hospital
city: Fukuoka
country: Japan
facility: Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hokkaido
country: Japan
facility: Teine Keijinkai Hospital
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanagawa
country: Japan
facility: Kitasato University hospital
city: Kumamoto
country: Japan
facility: Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectual University of Medicine
city: Mie
country: Japan
facility: Matsusaka Municipal Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Osaka Toneyama Medical Center
city: Osaka
country: Japan
facility: Kansai Medical University Hospital
city: Osaka
country: Japan
facility: NHO Kinki-Chuo Chest Medical Center
city: Tochigi
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Toho University Omori Medical Center
city: Yamaguchi
country: Japan
facility: Iwakuni Clinical Center
city: Yamaguchi
country: Japan
facility: Yamaguchi-Ube Medical Center
city: Yamanashi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Cheongjusi
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Jinju-si Gyeongsangnam-do
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System - Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea, Seoul St. Marys Hospital
city: Cuauhtemoc
country: Mexico
facility: Cryptex Investigacion Clinica Sa de Cv
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca CICLO
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: s-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis Jbz
city: Bialystok
country: Poland
facility: II Klinika Chorob Pluc i Gruzlicy
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki (Iczmp)
city: Lublin
country: Poland
facility: SPSK4, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Poznan
country: Poland
facility: Med Polonia Sp. Z O.O.
city: Warszawa
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
city: Lisbon
country: Portugal
facility: Fundacao Champalimaud
city: Porto
country: Portugal
facility: IPO Porto Francisco Gentil, E.P.E.
city: Cluj- Napoca
country: Romania
facility: Institute of Oncology Prof. Dr. Ion Chiricuta
city: Craiova
country: Romania
facility: Onco Clinic Consult Sa
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantu Nectarie
city: Timisoara
country: Romania
facility: Oncocenter Oncologie Clinica S.R.L
city: Barcelona
country: Spain
facility: Vall Hebron University Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Malaga
country: Spain
facility: Hospital Regional Universitario Malaga
city: Ourense
country: Spain
facility: CHUO
city: Sevilla
country: Spain
facility: Hosp Univ Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Valenica
country: Spain
facility: Hospital Universitario y Politecnico de La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Thun
country: Switzerland
facility: Spital Sts Ag
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Hsia
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Faculty of Medicine Chulalongkorn University
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital
city: Hat Yai
country: Thailand
facility: Prince of Songkla University PSU - Faculty of Medicine
city: Mueang Nonthaburi
country: Thailand
facility: Khon Kaen University - Faculty of Medicine-Srinagarind Hospital
city: Adana
country: Turkey
facility: Baskent University
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
city: Bağcılar
country: Turkey
facility: Medipol Mega University Hospital
city: Cankaya/Ankara
country: Turkey
facility: Memorial Ankara Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Medical Faculty
city: Seyhan
country: Turkey
facility: Adana Acibadem Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: