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)

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified February 2026 by Daiichi Sankyo
Sponsor
Daiichi Sankyo
Information Provided by (Responsible Party)
Daiichi Sankyo
Clinicaltrials.gov Identifier
NCT04656652
Other Study ID Numbers:
DS1062-A-U301
First Submitted
November 18, 2020
First Posted
December 6, 2020
Results First Posted
May 6, 2025
Last Update Posted
March 23, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Non-small Cell Lung Cancer
Drug: DS-1062aDrug: Docetaxel

Study Design

Study TypeInterventional
Actual Enrollment605 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitlePhase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)
Study Start DateDecember 20, 2020
Actual Primary Completion DateMay 9, 2024
Actual Study Completion Date8mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
DS-1062a 6.0 mg/kg
Participants will be randomized to receive 6.0 mg/kg of DS-1062a.
Drug: DS-1062a
DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
Docetaxel 75 mg/m^2
Participants will be randomized to receive 75 mg/m\^2 docetaxel.
Drug: Docetaxel
Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.

Outcome Measures

Primary Outcome Measures
  1. Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
    PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
  2. Overall Survival (OS) Following DS-1062a Versus Docetaxel
    OS is defined as the time from randomization to the date of death due to any cause.
Secondary Outcome Measures
  1. Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
    PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
  2. Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
    ORR is defined as the proportion of subjects who achieved a best overall response (BOR) of complete response (CR) or partial response (PR), as assessed by BICR and investigator per RECIST v1.1.
  3. Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
    DOR is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of radiographic Progressive Disease or death due to any cause, whichever occurs first.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 tyrosine kinase inhibitor (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

Contacts and Locations

Sponsors and CollaboratorsDaiichi Sankyo
Locations
Ironwood Cancer and Research Center | Chandler Arizona, United States, 85224St. Joseph Heritage Healthcare | Anaheim California, United States, 92835The Oncology Institute of Hope and Innovation | Glendale California, United States, 91204University of California San Diego | La Jolla California, United States, 92093UCLA | Los Angeles California, United States, 90095PIH Health | Whittier California, United States, 90602Memorial Healthcare System- Memorial Cancer Institute | Hollywood Florida, United States, 33021Orlando Health | Orlando Florida, United States, 32806Florida Cancer Specialists | Tallahassee Florida, United States, 32308Northwestern University | Chicago Illinois, United States, 60611University of Chicago | Chicago Illinois, United States, 60637Ft. Wayne Medical Oncology and Hematology | Fort Wayne Indiana, United States, 46804Baptist Health Louisville | Louisville Kentucky, United States, 40207Baton Rouge General | Baton Rouge Louisiana, United States, 70809American Oncology Partners of Maryland | Bethesda Maryland, United States, 20817Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02115Karmanos Cancer Institute | Detroit Michigan, United States, 48201OptumCare Cancer Care | Las Vegas Nevada, United States, 89106Meridian Hematology and Oncology | Manahawkin New Jersey, United States, 08050Astera Cancer Care | Somerset New Jersey, United States, 08873Montefiore Medical Center | The Bronx New York, United States, 10461Messino Cancer Centers | Asheville North Carolina, United States, 28806University Hospitals Cleveland Medical Center | Cleveland Ohio, United States, 44106Roger Williams Medical Center | Providence Rhode Island, United States, 02908Avera Cancer Institute | Sioux Falls South Dakota, United States, 57105Sarah Cannon Research Institute | Nashville Tennessee, United States, 37203The Center for Cancer and Blood Disorders | Fort Worth Texas, United States, 76104Utah Cancer Specialists | Salt Lake City Utah, United States, 84106University of Virginia Health System | Charlottesville Virginia, United States, 22903Virginia Cancer Specialist | Fairfax Virginia, United States, 22031Kadlec Clinic Hematology and Oncology | Kennewick Washington, United States, 99336Northwest Medical Specialties | Tacoma Washington, United States, 98405CER San Juan | Buenos Aires , Argentina, 01878Centro de Investigacion Pergamino S.A. | Pergamino , Argentina, B2700CPMInstituto de OncologÃÂ-a de Rosario | Rosario , Argentina, S2000KZEGaston Martinengo | Rosario , Argentina, S2000Flinders Medical Centre | Bedford Park , Australia, 05042Blacktown Hosital | Blacktown , Australia, 02148Austin Hospital | Heidelberg , Australia, 03084Macquarie Hospital | North Ryde , Australia, 02109Crown Princess Mary Cancer Centre Westmead Hospital | Sydney , Australia, 2145Southern Medical Day Care Centre | Wollongong , Australia, 02500Centre Hospitalier Jolimont-Lobbes | Haine-Saint-Paul , Belgium, 07100CHA Centre Hospitalier de l Ardenne | Libramont , Belgium, B-6800CHR site de la Citadelle | Liège , Belgium, 04000CHU UCL Namur | Yvoir , Belgium, 05530Instituto do Cancer do Ceara - ICC | Fortaleza , Brazil, 60430-230Hospital Sao Lucas da Pucrs | Porto Alegre , Brazil, 90610-000Hospital Nossa Senhora da Conceição | Porto Alegre , Brazil, 91350-200Instituto Nacional de Cancer-INCA | Rio de Janeiro , Brazil, 20231-050Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto , Brazil, 15090-000Cross Cancer Institute | Edmonton Alberta, Canada, T6G 1Z2University Health Network - Princess Margaret Hospital | Toronto Ontario, Canada, M5G0A3Sunnbrook Health Sciences Centre | Toronto Ontario, Canada, ON M4N 3M5MUHC-Glen Site and MUHC Research Institute | Montreal Quebec, Canada, H4A 3J1Beijing Cancer Hospital | Beijing , China, 100142Hunan Cancer Hospital | Changsha , China, Xiangya Hospital central south university | Changsha , China, Linyi Cancer Hospital | Hangzhou , China, 310003The First Affiliated Hospital of Zhejiang University | Hangzou , China, 310022Harbin Medical University Cancer Hospital | Heilongjiang , China, 150081Jiamusi Cancer Tuberculosis Hospital | Heilongjiang , China, 154007Fudan University Shanghai Cancer Center | Henan , China, 450008Hubei Cancer Hospital | Hubei , China, 430079Jiangsu Province Hospital | Nanjing , China, The First Affiliated Hospital of Xi'an Jiaotong University | Shandong , China, 276000Shanghai Chest Hospital | Shanghai , China, Henan Cancer Hospital | Shanghai Sheng , China, 200032Zhejiang Cancer Hospital | Shanxi , China, 710061West China Hospital, Sichuan University | Sichuan Province , China, Tianjin Medical University Cancer Institute and Hospital | Tianjin , China, 300060Affiliated Cancer Hospital of Xinjiang Medical University | Ürümqi , China, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan , China, 43002Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Zhejiang , China, 310016Vseobecna Fakultni Nemocnice VFN | Prague , Czechia, 12800Hopital Jean Minjoz | Besançon , France, 25030Centre Hospitalier Universitaire de Grenoble | Grenoble , France, 38043Centre Leon Berard | Lyon , France, 69008CHU Louis Pradel | Lyon , France, APHM - Hopital Nord | Marseille , France, 13915University Hospital of Nantes - Thoracic Oncology | Nantes , France, 44000Institut Curie | Paris , France, 75248CHU de Poitier Pole regional de Cancerologie | Poitiers , France, 86000Hopital Pontchaillou | Rennes , France, 35000Hopitaux Universitaire de Strasbourg | Strasbourg , France, 67098Hopital Foch | Sureesnes , France, 92150CHU Toulouse Hopital Larrey | Toulouse , France, 31059Gustav Roussy Cancer Campus Grand Paris | Villejuif , France, 94805Charite - Universitaetsmedizin Berlin | Berlin , Germany, 10117Evangelische Lungenklinik Berlin | Berlin , Germany, 13125Universitaet zu Koeln - Uniklinik Koeln | Cologne , Germany, 50937IKF Krankenhaus Nordwest | Frankfurt am Main , Germany, 60488Universitaetsklinikum Freiburg | Freiburg im Breisgau , Germany, 79106Asklepios Fachklinik Muenchen-Gauting | Gauting , Germany, 82131Thoraxklinik Heidelberg gGmbH | Heidelberg , Germany, 69126Lungenklinik Hemer | Hemer , Germany, 58675Klinikverbund Allgäu | Kempten , Germany, 87439Medizinische Klinik V | Standort Gießen , Germany, Klinikum Traunstein | Traunstein , Germany, Queen Mary Hospital | Hong Kong , Hong Kong, 999077Prince of Wales Hospital / The Chinese University of Hong Kong | Hong Kong , Hong Kong, 99999Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest , Hungary, 01121Uzsoki Utcai Korhaz | Budapest , Hungary, 1145Szent Borbala Korhaz | Tatabánya , Hungary, 02800Tolna Megyei Balassa Janos Korhaz | Tolna , Hungary, Tudogyogyintezet Torokbalint | Törökbálint , Hungary, H-2045Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi | Bologna , Italy, 40138Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco | Catania , Italy, 95030ASL 3 Genovese Oncologia Medica Villa Scassi | Genova , Italy, 16149Fondazione IRCCS Istituto Nazionale Tumori | Milan , Italy, 20133Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan , Italy, 20122IRCCS Istituto Europeo di Oncologia | Milan , Italy, 20141Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano , Italy, 10043Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma , Italy, 00168Instituicao de Fisioterapeutas Ocupacionais | Roma , Italy, RM00144Hyogo Cancer Center | Akashi , Japan, 673-8558Niigata Cancer Center Hospital | Chūōku , Japan, 951-8566Kyushu University Hospital | Fukuoka , Japan, 812-8582Saitama Medical University International Medical Center | Hidaka , Japan, 350-1298Kansai Medical University Hospital | Hirakata , Japan, 573-1191Kanazawa University Hospital | Kanazawa , Japan, 920-8641National Cancer Center Hospital East | Kashiwa , Japan, 277-8577The Cancer Institute Hospital of JFCR | Kōtoku , Japan, 135-8550Kyoto University Hospital | Kyoto , Japan, 606-8507NHO Shikoku Cancer Center | Matsuyama , Japan, 791-0280Shizuoka Cancer Center | Nagaizumi-chō , Japan, 411-8777Okayama University Hospital | Okayama , Japan, 36927Osaka City General Hospital | Osaka , Japan, 534-0021Osaka International Cancer Institute | Osaka , Japan, 541-8567Kindai University Hospital | Ōsaka-sayama , Japan, 589-8511Saitama Cancer Center | Saitama , Japan, 362-0806Sendai Kousei Hospital | Sendai , Japan, 980-0873NHO Hokkaido Cancer Center | Shiroishi , Japan, 003-0804Tokushima University Hospital | Tokushima , Japan, 770-8503National Cancer Center Hospital | Tokyo , Japan, 104-0045Fujita Health University Hospital | Toyoake , Japan, 470-1192San Peregrino Cancer Center | Aguascalientes , Mexico, 20230Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara , Mexico, 44280Hospital Medica Sur Tlalpan | Mexico City , Mexico, 14050Hospital Universitario Jose Eleuterio Gonzalez | Monterrey , Mexico, 64460Erasmus MC | Amsterdam , Netherlands, 3000 CAAmphia Ziekenhuis | Breda , Netherlands, 4818 CKIsala Klinieken | Harderwijk , Netherlands, 3844 DGSt. Jansdal Ziekenhuis | Rotterdam , Netherlands, 3015 CDII Klinika Chorob Pluc i Gruzlicy | Bialystok , Poland, 15-276Szpitale Pomorskie Sp.zo.o | Gdynia , Poland, 81-519Ms Pneumed | Lublin , Poland, 20-090SP Zespol Gruzlicy i Chorob Pluc | Olsztyn , Poland, 10-357Med Polonia Sp. z o.o. | Poznan , Poland, 60-693Szpital Specjalistyczny w Prabutach Sp. z o.o. | Prabuty , Poland, 82-550Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk | Słupsk , Poland, 76-200Magodent Sp. z.o.o Szpital Elblaska | Warsaw , Poland, 01-748Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw , Poland, 02-781FDI Clinical Research | San Juan , Puerto Rico, 00927SC Oncopremium Team SRL | Baia Mare , Romania, 430291Institutul Oncologic Profesor Doctor Alexandru Trestioreanu | Bucharest , Romania, 022328Centrul Medical Sanador | Bucharest , Romania, 20125Clinical Emergency Hospital | Constanța , Romania, 900591Onco Clinic Consult SA | Craiova , Romania, 200103Sf Nectarie Oncology Center | Craiova , Romania, 200347Oncolab SRL | Craiova , Romania, 200385SC Oncomed SRL | Timișoara , Romania, 300425Kursk Regional Clinical Oncology Dispensary | Kursk , Russia, 305524Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology | Moscow , Russia, 115478University Headache Clinic LLC | Moscow , Russia, 121467VitaMed LLC | Moscow , Russia, 129515Institute of Oncology Hadassah Moscow | Moscow , Russia, LLC MSCH "Klinitsist" | Novosibirsk , Russia, 630099N.N. Petrov Research Institute of Oncology | Saint Petersburg , Russia, 197758National Cancer Centre Singapore | Singapore , Singapore, 169610ICON Cancer Centre Farrer Park Hospital | Singapore , Singapore, 217562OncoCare Cancer Centre - Gleneagles Medical Centre Location | Singapore , Singapore, 258499Chungbuk National University Hospital | Cheongju-si , South Korea, 28644Kyungpook National University Chilgok Hospital | Daegu , South Korea, 41404St. Vincents Hospital The Catholic University of Korea | Gyeonggi-do , South Korea, 16247Seoul National University Bundang Hospital | Seongnam-si , South Korea, 13620Kangbuk Samsung Hospital | Seoul , South Korea, 03181Yonsei University Health System - Severance Hospital | Seoul , South Korea, 03722Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 06351The Catholic University of Korea, Seoul St. Marys Hospital | Seoul , South Korea, 06591Seoul National University Boramae Medical Center | Seoul , South Korea, 07061Hospital de la Santa Creu i Sant Pau | Barcelona , Spain, 08025Hospital Clinic i Provincial de Barcelona | Barcelona , Spain, 08036Hospital Universitario Vall d'Hebron | Barcelona , Spain, 80350Hospital Universitario Fundacion Jimenez Diaz | Madrid , Spain, 28040Hospital Universitario 12 de Octubre | Madrid , Spain, 28041Hospital Puerte de Hierro de Majadahonda | Madrid , Spain, 28222Hospital Regional Universitario Málaga | Málaga , Spain, 29010CHUO | Ourense , Spain, 32005Hospital Virgen Macarena | Seville , Spain, 41007Hospital Universitario de Valme | Seville , Spain, 41014Hospital General Universitario de Valencia | Valencia , Spain, 46014Hospital Universitari i Politecnic La Fe | Valencia , Spain, 46026Hospital Clinico Universitario Lozano Bleza | Zaragoza , Spain, 50009Inselspital Universitätsspital Bern | Bern , Switzerland, 3010Kantonsspital St. Gallen | Sankt Gallen , Switzerland, 9007Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology &amp; hematology | Zurich , Switzerland, 8063E-Da Hospital | Kaohsiung City , Taiwan, 00824Chang Gung Memorial Hospital CGMH - Kaohsiung Branch | Niaosong , Taiwan, 00833Chung Shan Medical University Hospital | Taichung , Taiwan, 00420Taichung Veterans General Hospital | Taichung , Taiwan, 40705National Cheng Kung University Hospital NCKUH | Tainan , Taiwan, 00704Chi Mei Medical Center CMMC - Liouying Branch | Tainan , Taiwan, 00736National Taiwan University Hospital NTUH | Taipei , Taiwan, 00100LinKou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 333University College Hospital | London , United Kingdom, NW1 2BUThe Christie Hospital | Manchester , United Kingdom, M20 4BXThe James Cook University Hospital | Middlesbrough , United Kingdom, TS4 3BW
Investigators
Study Director: Global Clinical Leader, Daiichi Sankyo
Study Documents (Full Text)
Documents provided by Daiichi Sankyo: Study Protocol and Statistical Analysis Plan  October 8, 2023