Clinical trial NCT04656652: Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
Official title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Metastatic Non-small Cell Lung Cancer
Advanced Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
DS-1062
Docetaxel
Datopotamab Deruxtecan (Dato-DXd)
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2020-12-07
Enrollment: 590
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 will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

Detailed description: This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m\^2 in participants with advanced or metastatic NSCLC with or without actionable genomic alterations (AGAs). Participants without actionable genomic alterations must have been previously treated with platinum-based chemotherapy and α (anti)-programmed cell death 1 (PD-1)/α-programmed cell death ligand 1 (PD-L1) monoclonal antibody, either in combination or sequentially. Participants with AGA must have progressed on or after 1 platinum-containing therapy and 1 to 2 prior lines of approved targeted therapy for the applicable genomic alteration. The study will be divided into 3 periods: 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 inform consent form (ICF) prior to the start of any study specific qualification procedures.
* Adults ≥18 years (if the legal age of consent is \>18 years old, then follow local regulatory requirements)
* Life expectancy ≥3 months
* Has pathologically documented Stage IIIB, IIIC, or stage IV NSCLC disease with or without actionable genomic alterations (AGA) at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition) and meets following criteria for NSCLC:
* Participants without AGA:

  1. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK).
  2. Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), mesenchymal-epithelial transition (MET) exon 14 skipping, or rearranged during transfection (RET).
* Participants with AGA must have one or more documented actionable genomic alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
* Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
* Participant without AGA must meet 1 of the following prior therapy requirements for advanced or metastatic NSCLC:

  1. Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal antibody as the only prior line of therapy.

     * Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III disease and relapsed/progressed within 6 months from the last dose of platinum-based chemotherapy.
     * Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody therapy (with or without platinum-based chemotherapy) for recurrent disease.
  2. Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.
* Participants with AGA must meet the following for advanced or metastatic NSCLC:

  1. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for the participant's genomic alteration at the time of screening;

     * Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior Osimertinib.
     * Those who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
     * Participants who have been treated with a prior TKI must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.
  2. Participants who have received platinum-based chemotherapy as the only prior line of cytotoxic therapy:

     * One platinum-containing regimen for advanced disease
     * Those who received a platinum-containing regimen as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of platinum-containing therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease.
  3. May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in combination with a cytotoxic agent.
* Must undergo a pre-treatment tumor biopsy procedure or if available, tumor tissue previously retrieved from a biopsy procedure performed within 2 years prior to the participant signing informed consent and that has a minimum of 10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for the pre-treatment biopsy procedure during Screening. If a documented law or regulation prohibits (or does not approve) sample collection, then such samples will not be collected/submitted
* Measurable disease based on local imaging assessment using RECIST v1.1
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening
* Within 7 days before randomization, has adequate bone marrow, hepatic, and renal function
* Left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization
* Adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × upper limit of normal (ULN)
* Adequate treatment washout period before randomization
* Females of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use highly effective birth control from the time of enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
* Males must be surgically sterile or must use a condom in addition to highly effective birth control if his partners are of reproductive potential from the time of enrollment and for at least 4 months after last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
* Male participants must not freeze or donate sperm from the time of Screening and throughout the study period and for at least 4 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
* Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study period and for at least 7 months after the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel

Exclusion Criteria:

* Mixed small-cell lung cancer (SCLC) and NSCLC histology
* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
* Has leptomeningeal carcinomatosis or metastasis
* Had prior treatment with:

  * Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I
  * TROP2-targeted therapy
  * Docetaxel
* Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease
* Has NSCLC disease that is eligible for definitive local therapy alone
* Has uncontrolled or significant cardiac disease, including:

  * Mean QT interval corrected for heart rate using Fridericia's formula \>470 msec (based on the average of Screening triplicate 12-lead electrocardiogram \[ECG\] determinations).
  * Myocardial infarction or uncontrolled/unstable angina within 6 months before randomization
  * Congestive heart failure (CHF) (New York Heart Association Class II to IV) at Screening. Participants 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.
  * Uncontrolled or significant cardiac arrhythmia
  * LVEF \<50% by ECHO or MUGA scan within 28 days before randomization
  * Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) within 28 days before randomization
* Has a history of (non-infectious) interstitial lung disease (ILD)/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 resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months before randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
* Significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
* Clinically significant corneal disease
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
* Has known human immunodeficiency virus (HIV) infection that is not well controlled
* Has an active or uncontrolled hepatitis B and/or hepatitis C infection, is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen \[HBsAg\], anti-hepatitis B surface antibody \[anti-HBs\], anti-hepatitis B core antibody \[anti-HBc\], or hepatitis B virus \[HBV\] DNA), and/or hepatitis C infection (as per hepatitis C virus \[HCV\] RNA) within 28 days of randomization.
* Has a history of malignancy, other than NSCLC, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years
* Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
* Has a history of severe hypersensitivity reactions to either the drug substances, inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel, or monoclonal antibodies
* Pregnant or breastfeeding
* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions

Primary outcomes:
measure: Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
measure: Overall Survival (OS) Following DS-1062a Versus Docetaxel
timeFrame: From randomization until date of death due to any cause, up to approximately 43 months
Secondary outcomes:
measure: Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
measure: Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
measure: Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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 43 months
measure: Disease Control Rate (DCR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
timeFrame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
measure: Time to Response (TTR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
timeFrame: From randomization to date of first objective response (CR or PR), up to approximately 43 months
measure: Time to Deterioration (TTD) Following DS-1062a Versus Docetaxel
timeFrame: Baseline and assessed on Day 15 of each cycle until disease progression or end of treatment (each cycle is 21 days) and then once more at +90 days end of treatment
measure: Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Versus Docetaxel
timeFrame: Baseline up to 35 days after last study dose, up to approximately 43 months
measure: Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of DS-1062a, Total Anti-Trophoblast cell surface protein 2 (Anti-TROP2) Antibody, and Active Metabolite MAAA-1181a
timeFrame: Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
measure: Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
timeFrame: Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
measure: Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
timeFrame: Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
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: Cycle 1, Day 1 predose; Cycle 1, Day 8; Cycles 2, 4, and subsequent cycles, Day 1 predose; end of treatment; 28-day safety follow up; and long-term survival follow up every 3 months, up to approximately 43 months (each cycle is 21 days)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Anaheim
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Glendale
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Whittier
country: United States
facility: PIH Health
state: California
city: Hollywood
country: United States
facility: Memorial Healthcare System- Memorial Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Fort Wayne
country: United States
facility: Ft. Wayne Medical Oncology and Hematology
state: Indiana
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Baton Rouge General
state: Louisiana
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: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Las Vegas
country: United States
facility: OptumCare Cancer Care
state: Nevada
city: Manahawkin
country: United States
facility: Meridian Hematology and Oncology
state: New Jersey
city: Somerset
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Asheville
country: United States
facility: Messino Cancer Centers
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialist
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Buenos Aires
country: Argentina
facility: CER San Juan
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino S.A.
city: Rosario
country: Argentina
facility: Instituto de OncologÃƒÂ-a de Rosario
city: Rosario
country: Argentina
facility: Gaston Martinengo
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Blacktown
country: Australia
facility: Blacktown Hosital
city: Heidelberg
country: Australia
facility: Austin Hospital
city: North Ryde
country: Australia
facility: Macquarie Hospital
city: Sydney
country: Australia
facility: Crown Princess Mary Cancer Centre Westmead Hospital
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
city: Haine-Saint-Paul
country: Belgium
facility: Centre Hospitalier Jolimont-Lobbes
city: Libramont
country: Belgium
facility: CHA Centre Hospitalier de l Ardenne
city: Liège
country: Belgium
facility: CHR site de la Citadelle
city: Yvoir
country: Belgium
facility: CHU UCL Namur
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara - ICC
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da Pucrs
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cancer-INCA
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnbrook Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: MUHC-Glen Site and MUHC Research Institute
state: Quebec
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: Xiangya Hospital central south university
city: Hangzhou
country: China
facility: Linyi Cancer Hospital
city: Hangzou
country: China
facility: The First Affiliated Hospital of Zhejiang University
city: Heilongjiang
country: China
facility: Harbin Medical University Cancer Hospital
city: Heilongjiang
country: China
facility: Jiamusi Cancer Tuberculosis Hospital
city: Henan
country: China
facility: Fudan University Shanghai Cancer Center
city: Hubei
country: China
facility: Hubei Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shandong
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Shanghai Sheng
country: China
facility: Henan Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanxi
country: China
facility: Zhejiang Cancer Hospital
city: Sichuan Province
country: China
facility: West China Hospital, Sichuan University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
city: Zhejiang
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice VFN
city: Besançon
country: France
facility: Hopital Jean Minjoz
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: CHU Louis Pradel
city: Marseille
country: France
facility: APHM - Hopital Nord
city: Nantes
country: France
facility: University Hospital of Nantes - Thoracic Oncology
city: Paris
country: France
facility: Institut Curie
city: Poitiers
country: France
facility: CHU de Poitier Pole regional de Cancerologie
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg
city: Sureesnes
country: France
facility: Hopital Foch
city: Toulouse
country: France
facility: CHU Toulouse Hopital Larrey
city: Villejuif
country: France
facility: Gustav Roussy Cancer Campus Grand Paris
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Frankfurt am main
country: Germany
facility: IKF Krankenhaus Nordwest
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Gauting
country: Germany
facility: Asklepios Fachklinik Muenchen-Gauting
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Kempten
country: Germany
facility: Klinikverbund AllgÃ¤u
city: Koeln
country: Germany
facility: Universitaet zu Koeln - Uniklinik Koeln
city: Standort Gießen
country: Germany
facility: Medizinische Klinik V
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital / The Chinese University of Hong Kong
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Tatabánya
country: Hungary
facility: Szent Borbala Korhaz
city: Tolna
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Bologna
country: Italy
facility: Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco
city: Genova
country: Italy
facility: ASL 3 Genovese Oncologia Medica Villa Scassi
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Roma
country: Italy
facility: Instituicao de Fisioterapeutas Ocupacionais
city: Akashi
country: Japan
facility: Hyogo Cancer Center
city: Chuo Ku
country: Japan
facility: Niigata Cancer Center Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Matsuyama
country: Japan
facility: NHO Shikoku Cancer Center
city: Nagaizumi-chō
country: Japan
facility: Shizuoka Cancer Center
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital
city: Shiroishi
country: Japan
facility: NHO Hokkaido Cancer Center
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Ōsaka-sayama
country: Japan
facility: Kindai University Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: St. Vincents Hospital The Catholic University of Korea
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System - Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Aguascalientes
country: Mexico
facility: San Peregrino Cancer Center
city: Ciudad de mexico
country: Mexico
facility: Hospital Medica Sur Tlalpan
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Monterrey
country: Mexico
facility: Hospital Universitario Jose Eleuterio Gonzalez
city: Amsterdam
country: Netherlands
facility: Erasmus MC
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Harderwijk
country: Netherlands
facility: Isala Klinieken
city: Rotterdam
country: Netherlands
facility: St. Jansdal Ziekenhuis
city: Białystok
country: Poland
facility: II Klinika Chorob Pluc i Gruzlicy
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp.zo.o
city: Lublin
country: Poland
facility: Ms Pneumed
city: Olsztyn
country: Poland
facility: SP Zespol Gruzlicy i Chorob Pluc
city: Poznań
country: Poland
facility: Med Polonia Sp. z o.o.
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Sp. z o.o.
city: Słupsk
country: Poland
facility: Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk
city: Warsaw
country: Poland
facility: Magodent Sp. z.o.o Szpital Elblaska
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Baia Mare
country: Romania
facility: SC Oncopremium Team SRL
city: Bucharest
country: Romania
facility: Centrul Medical Sanador
city: Bucuresti
country: Romania
facility: Institutul Oncologic Profesor Doctor Alexandru Trestioreanu
city: Constanţa
country: Romania
facility: Clinical Emergency Hospital
city: Craiova
country: Romania
facility: Onco Clinic Consult SA
city: Craiova
country: Romania
facility: Sf Nectarie Oncology Center
city: Craiova
country: Romania
facility: Oncolab SRL
city: Timişoara
country: Romania
facility: SC Oncomed SRL
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology
city: Moscow
country: Russian Federation
facility: University Headache Clinic LLC
city: Moscow
country: Russian Federation
facility: VitaMed LLC
city: Moscow
country: Russian Federation
facility: Institute of Oncology Hadassah Moscow
city: Novosibirsk
country: Russian Federation
facility: LLC MSCH "Klinitsist"
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: ICON Cancer Centre Farrer Park Hospital
city: Singapore
country: Singapore
facility: OncoCare Cancer Centre - Gleneagles Medical Centre Location
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Puerte de Hierro de Majadahonda
city: Málaga
country: Spain
facility: Hospital Regional Universitario Málaga
city: Ourense
country: Spain
facility: CHUO
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Bleza
city: Bern
country: Switzerland
facility: Inselspital UniversitÃ¤tsspital Bern
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology &amp; hematology
city: Kaohsiung City
country: Taiwan
facility: E-Da Hospital
city: Niaosong
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: Tainan
country: Taiwan
facility: Chi Mei Medical Center CMMC - Liouying Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital NTUH
city: Taoyuan
country: Taiwan
facility: LinKou Chang Gung Memorial Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: