Clinical trial NCT05215340: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
Official title: A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
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
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
name: Merck Sharp & Dohme LLC
First posted: 2022-01-31
Enrollment: 740
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 alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.

Detailed description: The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) by BICR or Overall Survival (OS) for participants with advanced or metastatic NSCLC with non-squamous histology without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC.

Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and Follow-up Period.

Eligibility criteria: Inclusion Criteria:

Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.

* Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
* Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
* Histologically documented non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0):

  1. Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study.
  2. Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations (AGAs) based on analysis of tumor tissue. If test results for EGFR, ALK, and ROS1 are not available, subjects are required to undergo testing performed locally for these genomic alterations.
  3. No known AGAs in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies. (Testing for genomic alterations besides EGFR, ALK, and ROS1 is not required prior to randomization). Subjects whose tumors harbor KRAS mutations are eligible for the study.
* Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
* Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
* Has an adequate treatment washout period before Cycle 1 Day 1.
* Measurable disease based on local imaging assessment using RECIST Version 1.1.
* Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
* Has a life expectancy of at least 3 months.
* Adequate bone marrow function within 7 days before randomization.

Exclusion Criteria:

* Has received prior systemic treatment for advanced or metastatic NSCLC.
* Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadjuvant setting:

  1. Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
  2. TROP2-targeted therapy.
  3. Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
  4. Any other immune checkpoint inhibitors. Participants 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/metastatic disease.
* Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases and who are asymptomatic may participate provided they are radiologically stable.
* Has received prior radiotherapy \< 4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.
* History of another primary malignancy (beyond NSCLC) except for:

  1. Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.
  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  3. Adequately treated carcinoma in situ without evidence of disease.
  4. Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Clinically severe pulmonary compromise, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.
* Uncontrolled or significant cardiovascular disease, including:

  1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval \>470 ms regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
  2. Myocardial infarction within 6 months prior to randomization.
  3. Uncontrolled angina pectoris within 6 months prior to randomization.
  4. LVEF \<50% by ECHO or MUGA scan within 28 days before randomization.
  5. New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
  6. Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) within 28 days before randomization.

Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.

* Clinically significant corneal disease.
* Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
* Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage \>10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
* Has known human immunodeficiency virus (HIV) infection that is not well controlled.
* Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.
* Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
* Had an allogeneic tissue/solid organ transplant.
* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.

Primary outcomes:
measure: Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
measure: Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
timeFrame: From randomization until date of death due to any cause, up to approximately 71 months
Secondary outcomes:
measure: OS in All Randomized Participants, Including Participants With Squamous and Non-Squamous Histology
timeFrame: From randomization until date of death due to any cause, up to approximately 71 months
measure: PFS Based on BICR in All Randomized Participants, Including Participants With Squamous and Non-Squamous Histology
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
measure: Progression-free Survival by Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
measure: Progression-free Survival 2 in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 71 months
measure: ORR by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: From randomization to first confirmed response, up to approximately 44 months
measure: Duration of Response by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
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 44 months
measure: Time to Response by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: From randomization to date of first objective response (CR or PR), up to approximately 44 months
measure: Disease Control Rate by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
measure: Time to Deterioration in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: From randomization until disease progression or death (whichever occurs first), up to 71 months
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE) with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: Up to 71 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 for Participants with Non-Squamous Histology, and Separately for All Randomized Participants
timeFrame: Baseline and up to 71 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA HemOnc - Clinical Research Unit
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Santa Barbara
country: United States
facility: Ridley-Tree Cancer Center
state: California
city: Whittier
country: United States
facility: PIH Health Whittier Hospital
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Colorado Springs
country: United States
facility: Uch-Mhs D/B/A Memorial Health System
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: DFCI - Steward St. Elizabeth's Medical Center
state: Massachusetts
city: Foxboro
country: United States
facility: Dana Farber Cancer Institute - Foxborough
state: Massachusetts
city: Milford
country: United States
facility: Dana Farber Cancer Institute - Milford Medical Center
state: Massachusetts
city: South Weymouth
country: United States
facility: DFCI - South Shore Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Freehold
country: United States
facility: Regional Cancer Care Associates LLC
state: New Jersey
city: New Brunswick
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Irving
country: United States
facility: Arizona Oncology NAHOA
state: Texas
city: Irving
country: United States
facility: Cancer Care Center of Brevard
state: Texas
city: Irving
country: United States
facility: Illinois Cancer Specialists
state: Texas
city: Irving
country: United States
facility: Maryland Oncology Hematology
state: Texas
city: Irving
country: United States
facility: Southern Cancer Center
state: Texas
city: Irving
country: United States
facility: Texas Oncology - Northeast Texas
state: Texas
city: Irving
country: United States
facility: Texas Oncology Gulf Coast
state: Texas
city: Irving
country: United States
facility: Texas Oncology McAllen
state: Texas
city: Irving
country: United States
facility: Woodlands Medical
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
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 - VAPSHCS
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fundacion CENIT para la investigación en Neurociencias
city: Mar del Plata
country: Argentina
facility: Hospital Privado de la Comunidad
city: Pergamino
country: Argentina
facility: Centro de Investigación Pergamino S. A.
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: Rosario
country: Argentina
facility: Sanatorio Británico de Rosario
city: San Juan
country: Argentina
facility: CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
city: Viedma
country: Argentina
facility: Clinica Viedma SA
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Mount Waverley
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: Camperdown
country: Australia
facility: Chris Obrien Lifehouse
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
city: Vienna
country: Austria
facility: Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Hopital Saint Joseph
city: Gent
country: Belgium
facility: Az Maria Middelares - Campus Maria Middelares
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Caxias Do Sul
country: Brazil
facility: Instituto de Pesquisas em Saúde - IPS
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Oncologia
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral
city: Pelotas
country: Brazil
facility: UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - 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 Pesquisas Sao Lucas
city: Taubate
country: Brazil
facility: Instituto do Cancer Brasil - Unidade Taubate
city: Montreal
country: Canada
facility: McGill University Health Centre
city: Montréal
country: Canada
facility: Santa Cabrini Hospital
city: Santiago de Chile
country: Chile
facility: Centro de Estudios Clínicos SAGA
state: Metropolitana
city: Santiago
country: Chile
facility: Oncovida
city: Santiago
country: Chile
facility: Fundación Arturo Pérez López
city: Santiago
country: Chile
facility: Orlandi Oncología
city: Vina Del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina Del Mar
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Beijing
country: China
facility: Peking University Peoples Hospital
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chongqing
country: China
facility: Army Medical Center of PLA
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University
city: Haikou
country: China
facility: Haikou People's Hospital
city: Hanghzou
country: China
facility: The First Affiliated Hospital of College of Medicine Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
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 Tumor and Tuberculosis Hospital
city: Kunming
country: China
facility: Yunnan 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: Jiangsu Province Hospital
city: Neijiang
country: China
facility: The Second People's Hospital of Neijiang
city: Shanghai Shi
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang City
country: China
facility: Liaoning Cancer Hospital& Institute
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an
country: China
facility: The First Affiliate Hospitalof Xi'An Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital Xiamen University
city: Xiangyang
country: China
facility: Xiangyang Central Hospital- 5 Lumen Avenue
city: Ürümqi
country: China
facility: Xinjiang Tumor Hospital
city: Avignon
country: France
facility: Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
city: Bordeaux
country: France
facility: Bordeaux University Hospital - Hopital Saint Andre
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille Cedex 9
country: France
facility: Institut Paoli-Calmettes
city: Marseille
country: France
facility: APHM - Hopital Nord
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Nantes Cedex 2
country: France
facility: Hopital prive du Confluent
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: AP-HP - Hopital Tenon
city: Poitiers
country: France
facility: CHU de Poitier Pole Regional de Cancerologie
city: Suresnes
country: France
facility: Hopital FOCH
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital
state: Athens
city: Athens
country: Greece
facility: Sotiria General Hosptial of Chest Diseases
city: Ioannina
country: Greece
facility: University Hospital of Ioannina Uhi
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital
city: Piraeus
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloniki
country: Greece
facility: St. Luke's Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital / The Chinese University of Hong Kong 99999
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Pok Fu Lam
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Semmelweis University Department of Pulmonology
city: Farkasgyepű
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet Farkasgyepu
city: KecskemĂŠt
country: Hungary
facility: Bkmk Hospital
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Torokbalint
country: Hungary
facility: Pulmonology Hospital Torokbalint
city: Bari
country: Italy
facility: IRCCS Istituto Oncologico Giovanni Paolo II
city: Chieti
country: Italy
facility: UOC Oncologia
city: Lucca
country: Italy
facility: Ospedale San Luca
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia
city: Naples
country: Italy
facility: Azienda Ospedaliera dei Colli
city: Perugia
country: Italy
facility: A.O. Perugia Santa Maria della Misericordia
city: Rome
country: Italy
facility: Policlinico Tor Vergata
city: Rome
country: Italy
facility: Ifo Regina Elena
city: Varese
country: Italy
facility: Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
city: Aomori-shi
country: Japan
facility: Aomori Prefectural Central Hospital
state: Aomori
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Saiseikai Kumamoto Hospital
state: Kumamoto
city: Matsusaka-shi
country: Japan
facility: Matsusaka Municipal Hospital
state: Mie
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Sakai-shi
country: Japan
facility: NHO Kinki-Chuo Chest Medical Center
state: Osaka
city: Ina-machi
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Toyko
city: Ota-ku
country: Japan
facility: Toho University Omori Medical Center
state: Toyko
city: Iwakuni-shi
country: Japan
facility: NHO Iwakuni Clinical Center
state: Yamaguchi
city: Ube-shi
country: Japan
facility: Yamaguchi-Ube Medical Center
state: Yamaguchi
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Osaka
country: Japan
facility: Osaka Toneyama Medical Center
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungbuk
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
city: Cuauhtémoc
country: Mexico
facility: Cryptex Investigacion Clinica Sa de Cv
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca (CICLO)
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam Umc, Location Vumc
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: s-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
state: Iodzkie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
state: Pomorskie
city: Szczecin
country: Poland
facility: Dom Lekarski SA
state: Zachodniopomorskie
city: Bialystok
country: Poland
facility: II Klinika Chorob Pluc I Gruzlicy
city: Lublin
country: Poland
facility: MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
city: Lisboa
country: Portugal
facility: Centro Clinico Champalimau
city: Porto
country: Portugal
facility: Centro Hospitalar e Universitário do Porto
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Porto
country: Portugal
facility: Instituto Portuguas de Oncologia do Porto Francisco Gentil
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
city: Craiova
country: Romania
facility: Onco Clinic Consult SA
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf Nectarie S.R.L.
city: Suceava
country: Romania
facility: Sc Sigmedical Services Srl
city: Timisoara
country: Romania
facility: Oncocenter-Oncologie Clinica SRL
city: Timisoara
country: Romania
facility: SC Oncomed SRL
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova - Lleida
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: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: St.Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Kaohsiung City
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital Nckuh
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital LinKou
city: Muaeng
country: Thailand
facility: Srinagarind Hospital
state: Khon Kaen
city: Hat Yai
country: Thailand
facility: Prince of Songkla University PSU - Faculty of Medicine
state: Songkhla
city: Bangkok
country: Thailand
facility: Faculty of Medicine Chulalongkorn University
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Adana
country: Turkey
facility: Adana Acibadem Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
city: Bornova-İzmir
country: Turkey
facility: Ege University
city: Cankaya
country: Turkey
facility: Memorial Ankara Hospital Ankara
city: İstanbul
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital
city: Seyhan /Adana
country: Turkey
facility: Medical Park Seyhan Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: