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)

Trial Title: 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)

NCT ID: NCT04656652

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel

Conditions: 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)

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: DS-1062a
Description: DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
Arm group label: DS-1062a 6.0 mg/kg

Other name: Datopotamab deruxtecan (Dato-DXd)

Intervention type: Drug
Intervention name: Docetaxel
Description: Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.
Arm group label: Docetaxel 75 mg/m^2

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ironwood Cancer and Research Center

Address:
City: Chandler
Zip: 85224
Country: United States

Facility:
Name: St. Joseph Heritage Healthcare

Address:
City: Anaheim
Zip: 92835
Country: United States

Facility:
Name: The Oncology Institute of Hope and Innovation

Address:
City: Glendale
Zip: 91204
Country: United States

Facility:
Name: University of California San Diego

Address:
City: La Jolla
Zip: 92093
Country: United States

Facility:
Name: UCLA

Address:
City: Los Angeles
Zip: 90095
Country: United States

Facility:
Name: PIH Health

Address:
City: Whittier
Zip: 90602
Country: United States

Facility:
Name: Memorial Healthcare System- Memorial Cancer Institute

Address:
City: Hollywood
Zip: 33021
Country: United States

Facility:
Name: Orlando Health

Address:
City: Orlando
Zip: 32806
Country: United States

Facility:
Name: Florida Cancer Specialists

Address:
City: Tallahassee
Zip: 32308
Country: United States

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Facility:
Name: University of Chicago

Address:
City: Chicago
Zip: 60637
Country: United States

Facility:
Name: Ft. Wayne Medical Oncology and Hematology

Address:
City: Fort Wayne
Zip: 46804
Country: United States

Facility:
Name: Baptist Health Louisville

Address:
City: Louisville
Zip: 40207
Country: United States

Facility:
Name: Baton Rouge General

Address:
City: Baton Rouge
Zip: 70809
Country: United States

Facility:
Name: American Oncology Partners of Maryland

Address:
City: Bethesda
Zip: 20817
Country: United States

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02115
Country: United States

Facility:
Name: Karmanos Cancer Institute

Address:
City: Detroit
Zip: 48201
Country: United States

Facility:
Name: OptumCare Cancer Care

Address:
City: Las Vegas
Zip: 89106
Country: United States

Facility:
Name: Meridian Hematology and Oncology

Address:
City: Manahawkin
Zip: 08050
Country: United States

Facility:
Name: Astera Cancer Care

Address:
City: Somerset
Zip: 08873
Country: United States

Facility:
Name: Montefiore Medical Center

Address:
City: Bronx
Zip: 10461
Country: United States

Facility:
Name: Messino Cancer Centers

Address:
City: Asheville
Zip: 28806
Country: United States

Facility:
Name: University Hospitals Cleveland Medical Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: Roger Williams Medical Center

Address:
City: Providence
Zip: 02908
Country: United States

Facility:
Name: Avera Cancer Institute

Address:
City: Sioux Falls
Zip: 57105
Country: United States

Facility:
Name: Sarah Cannon Research Institute

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: The Center for Cancer and Blood Disorders

Address:
City: Fort Worth
Zip: 76104
Country: United States

Facility:
Name: Utah Cancer Specialists

Address:
City: Salt Lake City
Zip: 84106
Country: United States

Facility:
Name: University of Virginia Health System

Address:
City: Charlottesville
Zip: 22903
Country: United States

Facility:
Name: Virginia Cancer Specialist

Address:
City: Fairfax
Zip: 22031
Country: United States

Facility:
Name: Kadlec Clinic Hematology and Oncology

Address:
City: Kennewick
Zip: 99336
Country: United States

Facility:
Name: Northwest Medical Specialties

Address:
City: Tacoma
Zip: 98405
Country: United States

Facility:
Name: CER San Juan

Address:
City: Buenos Aires
Zip: 01878
Country: Argentina

Facility:
Name: Centro de Investigacion Pergamino S.A.

Address:
City: Pergamino
Zip: B2700CPM
Country: Argentina

Facility:
Name: Instituto de OncologÃÂ-a de Rosario

Address:
City: Rosario
Zip: S2000KZE
Country: Argentina

Facility:
Name: Gaston Martinengo

Address:
City: Rosario
Zip: S2000
Country: Argentina

Facility:
Name: Flinders Medical Centre

Address:
City: Bedford Park
Zip: 05042
Country: Australia

Facility:
Name: Blacktown Hosital

Address:
City: Blacktown
Zip: 02148
Country: Australia

Facility:
Name: Austin Hospital

Address:
City: Heidelberg
Zip: 03084
Country: Australia

Facility:
Name: Macquarie Hospital

Address:
City: North Ryde
Zip: 02109
Country: Australia

Facility:
Name: Crown Princess Mary Cancer Centre Westmead Hospital

Address:
City: Sydney
Zip: 2145
Country: Australia

Facility:
Name: Southern Medical Day Care Centre

Address:
City: Wollongong
Zip: 02500
Country: Australia

Facility:
Name: Centre Hospitalier Jolimont-Lobbes

Address:
City: Haine-Saint-Paul
Zip: 07100
Country: Belgium

Facility:
Name: CHA Centre Hospitalier de l Ardenne

Address:
City: Libramont
Zip: B-6800
Country: Belgium

Facility:
Name: CHR site de la Citadelle

Address:
City: Liège
Zip: 04000
Country: Belgium

Facility:
Name: CHU UCL Namur

Address:
City: Yvoir
Zip: 05530
Country: Belgium

Facility:
Name: Instituto do Cancer do Ceara - ICC

Address:
City: Fortaleza
Zip: 60430-230
Country: Brazil

Facility:
Name: Hospital Sao Lucas da Pucrs

Address:
City: Porto Alegre
Zip: 90610-000
Country: Brazil

Facility:
Name: Hospital Nossa Senhora da Conceição

Address:
City: Porto Alegre
Zip: 91350-200
Country: Brazil

Facility:
Name: Instituto Nacional de Cancer-INCA

Address:
City: Rio De Janeiro
Zip: 20231-050
Country: Brazil

Facility:
Name: Hospital de Base de Sao Jose do Rio Preto

Address:
City: São José Do Rio Preto
Zip: 15090-000
Country: Brazil

Facility:
Name: Cross Cancer Institute

Address:
City: Edmonton
Zip: T6G 1Z2
Country: Canada

Facility:
Name: University Health Network - Princess Margaret Hospital

Address:
City: Toronto
Zip: M5G0A3
Country: Canada

Facility:
Name: Sunnbrook Health Sciences Centre

Address:
City: Toronto
Zip: ON M4N 3M5
Country: Canada

Facility:
Name: MUHC-Glen Site and MUHC Research Institute

Address:
City: Montréal
Zip: H4A 3J1
Country: Canada

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Hunan Cancer Hospital

Address:
City: Changsha
Country: China

Facility:
Name: Xiangya Hospital central south university

Address:
City: Changsha
Country: China

Facility:
Name: Linyi Cancer Hospital

Address:
City: Hangzhou
Zip: 310003
Country: China

Facility:
Name: The First Affiliated Hospital of Zhejiang University

Address:
City: Hangzou
Zip: 310022
Country: China

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Heilongjiang
Zip: 150081
Country: China

Facility:
Name: Jiamusi Cancer Tuberculosis Hospital

Address:
City: Heilongjiang
Zip: 154007
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Henan
Zip: 450008
Country: China

Facility:
Name: Hubei Cancer Hospital

Address:
City: Hubei
Zip: 430079
Country: China

Facility:
Name: Jiangsu Province Hospital

Address:
City: Nanjing
Country: China

Facility:
Name: The First Affiliated Hospital of Xi'an Jiaotong University

Address:
City: Shandong
Zip: 276000
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Shanghai Sheng
Zip: 200032
Country: China

Facility:
Name: Shanghai Chest Hospital

Address:
City: Shanghai
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Shanxi
Zip: 710061
Country: China

Facility:
Name: West China Hospital, Sichuan University

Address:
City: Sichuan Province
Country: China

Facility:
Name: Tianjin Medical University Cancer Institute and Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Facility:
Name: Affiliated Cancer Hospital of Xinjiang Medical University

Address:
City: Urumqi
Country: China

Facility:
Name: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Address:
City: Wuhan
Zip: 43002
Country: China

Facility:
Name: Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Address:
City: Zhejiang
Zip: 310016
Country: China

Facility:
Name: Vseobecna Fakultni Nemocnice VFN

Address:
City: Praha
Zip: 12800
Country: Czechia

Facility:
Name: Hopital Jean Minjoz

Address:
City: Besançon
Zip: 25030
Country: France

Facility:
Name: Centre Hospitalier Universitaire de Grenoble

Address:
City: Grenoble
Zip: 38043
Country: France

Facility:
Name: Centre Leon Berard

Address:
City: Lyon
Zip: 69008
Country: France

Facility:
Name: CHU Louis Pradel

Address:
City: Lyon
Country: France

Facility:
Name: APHM - Hopital Nord

Address:
City: Marseille
Zip: 13915
Country: France

Facility:
Name: University Hospital of Nantes - Thoracic Oncology

Address:
City: Nantes
Zip: 44000
Country: France

Facility:
Name: Institut Curie

Address:
City: Paris
Zip: 75248
Country: France

Facility:
Name: CHU de Poitier Pole regional de Cancerologie

Address:
City: Poitiers
Zip: 86000
Country: France

Facility:
Name: Hopital Pontchaillou

Address:
City: Rennes
Zip: 35000
Country: France

Facility:
Name: Hopitaux Universitaire de Strasbourg

Address:
City: Strasbourg
Zip: 67098
Country: France

Facility:
Name: Hopital Foch

Address:
City: Sureesnes
Zip: 92150
Country: France

Facility:
Name: CHU Toulouse Hopital Larrey

Address:
City: Toulouse
Zip: 31059
Country: France

Facility:
Name: Gustav Roussy Cancer Campus Grand Paris

Address:
City: Villejuif
Zip: 94805
Country: France

Facility:
Name: Charite - Universitaetsmedizin Berlin

Address:
City: Berlin
Zip: 10117
Country: Germany

Facility:
Name: Evangelische Lungenklinik Berlin

Address:
City: Berlin
Zip: 13125
Country: Germany

Facility:
Name: IKF Krankenhaus Nordwest

Address:
City: Frankfurt am main
Zip: 60488
Country: Germany

Facility:
Name: Universitaetsklinikum Freiburg

Address:
City: Freiburg
Zip: 79106
Country: Germany

Facility:
Name: Asklepios Fachklinik Muenchen-Gauting

Address:
City: Gauting
Zip: 82131
Country: Germany

Facility:
Name: Thoraxklinik Heidelberg gGmbH

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: Lungenklinik Hemer

Address:
City: Hemer
Zip: 58675
Country: Germany

Facility:
Name: Klinikverbund Allgäu

Address:
City: Kempten
Zip: 87439
Country: Germany

Facility:
Name: Universitaet zu Koeln - Uniklinik Koeln

Address:
City: Koeln
Zip: 50937
Country: Germany

Facility:
Name: Medizinische Klinik V

Address:
City: Standort Gießen
Country: Germany

Facility:
Name: Klinikum Traunstein

Address:
City: Traunstein
Country: Germany

Facility:
Name: Queen Mary Hospital

Address:
City: Hong Kong
Zip: 999077
Country: Hong Kong

Facility:
Name: Prince of Wales Hospital / The Chinese University of Hong Kong

Address:
City: Hong Kong
Zip: 99999
Country: Hong Kong

Facility:
Name: Orszagos Koranyi TBC es Pulmonologiai Intezet

Address:
City: Budapest
Zip: 01121
Country: Hungary

Facility:
Name: Uzsoki Utcai Korhaz

Address:
City: Budapest
Zip: 1145
Country: Hungary

Facility:
Name: Szent Borbala Korhaz

Address:
City: Tatabánya
Zip: 02800
Country: Hungary

Facility:
Name: Tolna Megyei Balassa Janos Korhaz

Address:
City: Tolna
Country: Hungary

Facility:
Name: Tudogyogyintezet Torokbalint

Address:
City: Torokbalint
Zip: H-2045
Country: Hungary

Facility:
Name: Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi

Address:
City: Bologna
Zip: 40138
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

Address:
City: Catania
Zip: 95030
Country: Italy

Facility:
Name: ASL 3 Genovese Oncologia Medica Villa Scassi

Address:
City: Genova
Zip: 16149
Country: Italy

Facility:
Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Address:
City: Milano
Zip: 20122
Country: Italy

Facility:
Name: IRCCS Istituto Europeo di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Fondazione IRCCS Istituto Nazionale Tumori

Address:
City: Milan
Zip: 20133
Country: Italy

Facility:
Name: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Address:
City: Orbassano
Zip: 10043
Country: Italy

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: Instituicao de Fisioterapeutas Ocupacionais

Address:
City: Roma
Zip: RM00144
Country: Italy

Facility:
Name: Hyogo Cancer Center

Address:
City: Akashi
Zip: 673-8558
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital

Address:
City: Chuo Ku
Zip: 951-8566
Country: Japan

Facility:
Name: Kyushu University Hospital

Address:
City: Fukuoka
Zip: 812-8582
Country: Japan

Facility:
Name: Saitama Medical University International Medical Center

Address:
City: Hidaka
Zip: 350-1298
Country: Japan

Facility:
Name: Kansai Medical University Hospital

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Facility:
Name: Kanazawa University Hospital

Address:
City: Kanazawa
Zip: 920-8641
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa
Zip: 277-8577
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR

Address:
City: Koto-Ku
Zip: 135-8550
Country: Japan

Facility:
Name: Kyoto University Hospital

Address:
City: Kyoto
Zip: 606-8507
Country: Japan

Facility:
Name: NHO Shikoku Cancer Center

Address:
City: Matsuyama
Zip: 791-0280
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Nagaizumi-chō
Zip: 411-8777
Country: Japan

Facility:
Name: Okayama University Hospital

Address:
City: Okayama
Zip: 36927
Country: Japan

Facility:
Name: Osaka City General Hospital

Address:
City: Osaka-shi
Zip: 534-0021
Country: Japan

Facility:
Name: Osaka International Cancer Institute

Address:
City: Osaka
Zip: 541-8567
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Saitama
Zip: 362-0806
Country: Japan

Facility:
Name: Sendai Kousei Hospital

Address:
City: Sendai-shi
Zip: 980-0873
Country: Japan

Facility:
Name: NHO Hokkaido Cancer Center

Address:
City: Shiroishi
Zip: 003-0804
Country: Japan

Facility:
Name: Tokushima University Hospital

Address:
City: Tokushima
Zip: 770-8503
Country: Japan

Facility:
Name: National Cancer Center Hospital

Address:
City: Tokyo
Zip: 104-0045
Country: Japan

Facility:
Name: Fujita Health University Hospital

Address:
City: Toyoake
Zip: 470-1192
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Ōsaka-sayama
Zip: 589-8511
Country: Japan

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Kyungpook National University Chilgok Hospital

Address:
City: Daegu
Zip: 41404
Country: Korea, Republic of

Facility:
Name: St. Vincents Hospital The Catholic University of Korea

Address:
City: Gyeonggi-do
Zip: 16247
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Kangbuk Samsung Hospital

Address:
City: Seoul
Zip: 03181
Country: Korea, Republic of

Facility:
Name: Yonsei University Health System - Severance Hospital

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, Seoul St. Marys Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Seoul National University Boramae Medical Center

Address:
City: Seoul
Zip: 07061
Country: Korea, Republic of

Facility:
Name: San Peregrino Cancer Center

Address:
City: Aguascalientes
Zip: 20230
Country: Mexico

Facility:
Name: Hospital Medica Sur Tlalpan

Address:
City: Ciudad de mexico
Zip: 14050
Country: Mexico

Facility:
Name: Hospital Civil de Guadalajara Fray Antonio Alcalde

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: Hospital Universitario Jose Eleuterio Gonzalez

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Facility:
Name: Erasmus MC

Address:
City: Amsterdam
Zip: 3000 CA
Country: Netherlands

Facility:
Name: Amphia Ziekenhuis

Address:
City: Breda
Zip: 4818 CK
Country: Netherlands

Facility:
Name: Isala Klinieken

Address:
City: Harderwijk
Zip: 3844 DG
Country: Netherlands

Facility:
Name: St. Jansdal Ziekenhuis

Address:
City: Rotterdam
Zip: 3015 CD
Country: Netherlands

Facility:
Name: II Klinika Chorob Pluc i Gruzlicy

Address:
City: Białystok
Zip: 15-276
Country: Poland

Facility:
Name: Szpitale Pomorskie Sp.zo.o

Address:
City: Gdynia
Zip: 81-519
Country: Poland

Facility:
Name: Ms Pneumed

Address:
City: Lublin
Zip: 20-090
Country: Poland

Facility:
Name: SP Zespol Gruzlicy i Chorob Pluc

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: Med Polonia Sp. z o.o.

Address:
City: Poznań
Zip: 60-693
Country: Poland

Facility:
Name: Szpital Specjalistyczny w Prabutach Sp. z o.o.

Address:
City: Prabuty
Zip: 82-550
Country: Poland

Facility:
Name: Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk

Address:
City: Słupsk
Zip: 76-200
Country: Poland

Facility:
Name: Magodent Sp. z.o.o Szpital Elblaska

Address:
City: Warsaw
Zip: 01-748
Country: Poland

Facility:
Name: Maria Sklodowska-Curie National Research Institute of Oncology

Address:
City: Warsaw
Zip: 02-781
Country: Poland

Facility:
Name: FDI Clinical Research

Address:
City: San Juan
Zip: 00927
Country: Puerto Rico

Facility:
Name: SC Oncopremium Team SRL

Address:
City: Baia Mare
Zip: 430291
Country: Romania

Facility:
Name: Centrul Medical Sanador

Address:
City: Bucharest
Zip: 20125
Country: Romania

Facility:
Name: Institutul Oncologic Profesor Doctor Alexandru Trestioreanu

Address:
City: Bucuresti
Zip: 022328
Country: Romania

Facility:
Name: Clinical Emergency Hospital

Address:
City: Constanţa
Zip: 900591
Country: Romania

Facility:
Name: Onco Clinic Consult SA

Address:
City: Craiova
Zip: 200103
Country: Romania

Facility:
Name: Sf Nectarie Oncology Center

Address:
City: Craiova
Zip: 200347
Country: Romania

Facility:
Name: Oncolab SRL

Address:
City: Craiova
Zip: 200385
Country: Romania

Facility:
Name: SC Oncomed SRL

Address:
City: Timişoara
Zip: 300425
Country: Romania

Facility:
Name: Kursk Regional Clinical Oncology Dispensary

Address:
City: Kursk
Zip: 305524
Country: Russian Federation

Facility:
Name: Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: University Headache Clinic LLC

Address:
City: Moscow
Zip: 121467
Country: Russian Federation

Facility:
Name: VitaMed LLC

Address:
City: Moscow
Zip: 129515
Country: Russian Federation

Facility:
Name: Institute of Oncology Hadassah Moscow

Address:
City: Moscow
Country: Russian Federation

Facility:
Name: LLC MSCH "Klinitsist"

Address:
City: Novosibirsk
Zip: 630099
Country: Russian Federation

Facility:
Name: N.N. Petrov Research Institute of Oncology

Address:
City: Saint Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: National Cancer Centre Singapore

Address:
City: Singapore
Zip: 169610
Country: Singapore

Facility:
Name: ICON Cancer Centre Farrer Park Hospital

Address:
City: Singapore
Zip: 217562
Country: Singapore

Facility:
Name: OncoCare Cancer Centre - Gleneagles Medical Centre Location

Address:
City: Singapore
Zip: 258499
Country: Singapore

Facility:
Name: Hospital de la Santa Creu i Sant Pau

Address:
City: Barcelona
Zip: 08025
Country: Spain

Facility:
Name: Hospital Clinic i Provincial de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hospital Universitario Vall d'Hebron

Address:
City: Barcelona
Zip: 80350
Country: Spain

Facility:
Name: Hospital Universitario Fundacion Jimenez Diaz

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Puerte de Hierro de Majadahonda

Address:
City: Madrid
Zip: 28222
Country: Spain

Facility:
Name: Hospital Regional Universitario Málaga

Address:
City: Málaga
Zip: 29010
Country: Spain

Facility:
Name: CHUO

Address:
City: Ourense
Zip: 32005
Country: Spain

Facility:
Name: Hospital Virgen Macarena

Address:
City: Sevilla
Zip: 41007
Country: Spain

Facility:
Name: Hospital Universitario de Valme

Address:
City: Sevilla
Zip: 41014
Country: Spain

Facility:
Name: Hospital General Universitario de Valencia

Address:
City: Valencia
Zip: 46014
Country: Spain

Facility:
Name: Hospital Universitari i Politecnic La Fe

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Hospital Clinico Universitario Lozano Bleza

Address:
City: Zaragoza
Zip: 50009
Country: Spain

Facility:
Name: Inselspital Universitätsspital Bern

Address:
City: Bern
Zip: 3010
Country: Switzerland

Facility:
Name: Kantonsspital St. Gallen

Address:
City: Saint Gallen
Zip: 9007
Country: Switzerland

Facility:
Name: Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology

Address:
City: Zürich
Zip: 8063
Country: Switzerland

Facility:
Name: E-Da Hospital

Address:
City: Kaohsiung City
Zip: 00824
Country: Taiwan

Facility:
Name: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

Address:
City: Niaosong
Zip: 00833
Country: Taiwan

Facility:
Name: Chung Shan Medical University Hospital

Address:
City: Taichung
Zip: 00420
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital NCKUH

Address:
City: Tainan
Zip: 00704
Country: Taiwan

Facility:
Name: Chi Mei Medical Center CMMC - Liouying Branch

Address:
City: Tainan
Zip: 00736
Country: Taiwan

Facility:
Name: National Taiwan University Hospital NTUH

Address:
City: Taipei
Zip: 00100
Country: Taiwan

Facility:
Name: LinKou Chang Gung Memorial Hospital

Address:
City: Taoyuan
Zip: 333
Country: Taiwan

Facility:
Name: University College Hospital

Address:
City: London
Zip: NW1 2BU
Country: United Kingdom

Facility:
Name: The Christie Hospital

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Facility:
Name: The James Cook University Hospital

Address:
City: Middlesbrough
Zip: TS4 3BW
Country: United Kingdom

Start date: December 21, 2020

Completion date: June 21, 2025

Lead sponsor:
Agency: Daiichi Sankyo
Agency class: Industry

Collaborator:
Agency: AstraZeneca
Agency class: Industry

Source: Daiichi Sankyo

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04656652