Lung Cancer Clinical Trial

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Summary

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

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Full Description

Patritumab deruxtecan (HER3-DXd, U3-1402) is an antibody-drug conjugate (ADC) comprising an anti-HER3 mAb linked to a topoisomerase I inhibitor that is in clinical development for patients with NSCLC, metastatic breast cancer, and colorectal cancer.

The primary objective of the current study is to compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by progression-free survival (PFS) and the key secondary endpoint of overall survival (OS), in participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (eg, osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Is a male or female subject aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation.
Has documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter.
Received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a third -generation EGFR TKI
May have received either neoadjuvant and/or adjuvant treatment if progression to metastatic or locally advanced disease occurred at least 12 months after the last dose of such therapy and subsequently experienced disease progression on or after third-generation EGFR TKI treatment administered in the metastatic or locally advanced setting.
Has not received any other prior systemic therapies in the metastatic or locally advanced setting (including chemotherapy, immunotherapy etc) (even if administered in combination with EGFR TKI).
Has documentation of radiographic disease progression while receiving or after receiving a third generation EGFR TKI for metastatic or locally advanced disease.
Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment.
Is willing to have a tumor biopsy or provide recently obtained tumor tissue.
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.

Has adequate bone marrow reserve and organ function based on local laboratory evaluation within 14 days prior to randomization:

Platelet count: ≥100,000/mm^3 or ≥100 × 10^9/L
Absolute neutrophil count: ≥1500/mm^3 or ≥1.5 × 10^9/L
Hemoglobin (Hgb): ≥9.0 g/dL
Creatine clearance (CrCl): CrCl ≥45 mL/min calculated by using the Cockcroft-Gault equation or measured CrCl
Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): AST/ALT ≤3× Upper limit of normal (ULN)
Total bilirubin (TBL): TBL ≤1.5 × ULN
Serum albumin: ≥2.5 g/dL
Prothrombin time (PT) or Prothrombin time-International normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT): ≤1.5 × ULN, except for participants receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy who must have PT-INR within therapeutic range as deemed appropriate by the Investigator

Exclusion Criteria:

Has any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy, or squamous NSCLC histology
Has any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during Screening

Has clinically severe respiratory compromise (based on the Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to the following:

Any underlying pulmonary disorder, restrictive lung disease, or pleural effusion
Any autoimmune, connective tissue, or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of Screening
OR prior complete pneumonectomy
Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization
Has evidence of any leptomeningeal disease
Has evidence of clinically active spinal cord compression or brain metastases, defined as being symptomatic and untreated, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
Any prior treatment with any agent including an antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I, human epidermal growth factor receptor 3 (HER3) antibody, and any systemic therapies (other than EGFR TKIs) in the metastatic/locally advanced setting, including chemotherapy or any other systemic therapy in combination with an EGFR TKI
Has history of other active malignancy within 3 years prior to randomization, except for adequately resected nonmelanoma skin cancer, adequately treated intraepithelial carcinoma of the cervix, and any other curatively treated in situ disease
Has uncontrolled or significant cardiovascular disease prior to randomization
Has active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of randomization
Has a known human immunodeficiency virus (HIV) infection that is not well controlled
Has clinically significant corneal disease

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

560

Study ID:

NCT05338970

Recruitment Status:

Recruiting

Sponsor:

Daiichi Sankyo, Inc.

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There are 174 Locations for this study

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Alaska Oncology and Hematology LLC
Anchorage Alaska, 99508, United States More Info
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Highlands Oncology
Springdale Arkansas, 72762, United States More Info
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City of Hope
Duarte California, 91010, United States More Info
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Moores Cancer Center at the UC San Diego Health
La Jolla California, 92037, United States More Info
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Scripps MD Anderson Cancer Center
La Jolla California, 92037, United States More Info
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USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
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Kaiser Permanente - Vallejo Medical Center
Vallejo California, 94589, United States More Info
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Innovative Clinical Research Institute
Whittier California, 90603, United States More Info
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Sarah Cannon/Florida Cancer Specialists - FCS South
Port Charlotte Florida, 33980, United States More Info
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Emory University
Atlanta Georgia, 30322, United States More Info
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St Luke's Cancer Institute
Boise Idaho, 83712, United States More Info
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The University of Chicago
Chicago Illinois, 60637, United States
American Oncology Partners of Maryland
Bethesda Maryland, 20817, United States More Info
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Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States More Info
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Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin New Jersey, 08050, United States More Info
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Montefiore Medical Center
Bronx New York, 10467, United States More Info
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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
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Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
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Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
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University of Texas Southwestern Medical Center
Dallas Texas, 75235, United States More Info
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Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
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Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
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University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info
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The Chris O'Brien Lifehouse
Camperdown , 2050, Australia More Info
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St George Public Hospital
Kogarah , 2217, Australia More Info
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Liverpool Hospital
Liverpool , 2170, Australia More Info
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Austin Hospital
Melbourne , 3084, Australia More Info
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St John of God Subiaco Hospital
Subiaco , 6008, Australia More Info
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Princess Alexandra Hospital
Woolloongabba , 4102, Australia More Info
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Landeskrankenhaus Feldkirch
Feldkirch , 6800, Austria More Info
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Medizinische Universitaet Innsbruck
Innsbruck , 6020, Austria More Info
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Klinikum Klagenfurt Pulmologie
Klagenfurt , 9020, Austria More Info
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Klinikum Wels-Grieskirchen
Wels , 4600, Austria More Info
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Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Wien , 1210, Austria More Info
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Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium More Info
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UZ Leuven
Leuven , 3000, Belgium More Info
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AZ Sint Maarten Mechelen
Mechelen , 2800, Belgium More Info
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AZ Delta
Roeselare , 8800, Belgium More Info
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William Osler Health System - Brampton Civic Hospital
Brampton , L6R 3, Canada More Info
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Sunnybrook Health Sciences Ctr
Toronto , M4N 3, Canada More Info
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Peking University Cancer Hospital
Beijing , 10014, China More Info
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Jilin Cancer Hospital
Chang chun , 13002, China More Info
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University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital
Chengdu , 61004, China More Info
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National Cancer Center Hospital East
Chibi , 260-0, China More Info
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Fujian Medical University - Union Hospital Foochow Christian Union Hospital
Fuzhou , 35000, China More Info
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Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital
Guangzhou , 51008, China More Info
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The First Affiliated Hospital Sun-Yat-Sen University
Guangzhou , 51008, China More Info
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The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou , 31000, China More Info
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Zhejiang Cancer hospital
Hangzhou , 31002, China More Info
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Harbin Medical University - Tumor Hospital The Third Affiliated Hospital
Harbin , 15008, China More Info
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The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology
Hefei , 23002, China More Info
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Henan Provincial Peoples Hospital
Henan , 45000, China More Info
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The Second Affiliated Hospital of Kunming Medical University
Kunming , 65003, China More Info
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General Hospital of Eastern Theater Command
Nanjing , 21000, China More Info
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The First Affiliated Hospital of Guangxi Medical University
Nanning , 53002, China More Info
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Fudan University - Shanghai Cancer Center FUSCC
Shanghai , 20003, China More Info
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Cancer Hospital of Shantou University Medical College
Shantou , 51504, China More Info
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Liaoning Cancer Hospital & Institute
Shenyang , 11004, China More Info
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Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan , 43002, China More Info
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Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
Wuhan , 43003, China More Info
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The First Affiliate Hospital of Xi'an Jiaotong University
Xi'an , 71006, China More Info
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Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi , 83000, China More Info
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Hopital Morvan CHU de Brest
Brest , 29609, France More Info
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Centre Francois Baclesse
Caen , 14076, France More Info
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Centre Francois Baclesse
Caen , 14076, France More Info
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Centre Leon Berard
Lyon , 69008, France More Info
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Montpellier Cancer Institute ICM
Montpellier , 34298, France More Info
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Institut Curie
Paris Cedex 05 , 75005, France More Info
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APHP - Hopital Saint Louis
Paris , 75010, France More Info
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Centre Hospitalier Lyon Sud
Pierre-Bénite , 69495, France More Info
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Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes , 35000, France More Info
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Institut de Cancrologie de lOuest ICO
Saint-Herblain , 44805, France More Info
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Gustave Roussy
Villejuif , 94805, France More Info
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Universitaetsklinikum Essen
Essen , 45147, Germany More Info
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Klinikum Esslingen GmbH
Esslingen , 73730, Germany More Info
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IKF Krankenhaus Nordwest
Frankfurt am main , 60488, Germany More Info
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Asklepios Fachklinik Muenchen-Gauting
Gauting , 82131, Germany More Info
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Universitatsklinik Giessen und Marburg
Gießen , 35392, Germany More Info
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LungenClinic Grosshansdorf
Großhansdorf , 22927, Germany More Info
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Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany More Info
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LKI Lungenfachklinik Immenhausen
Immenhausen , 34376, Germany More Info
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Klinikverbund Allgaeu
Kempten , 87439, Germany More Info
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Klinikum Nuernberg Nord
Nürnberg , 90419, Germany
Pius-Hospital Oldenburg
Oldenburg , 26121, Germany More Info
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Universitaetsklinikum Wurzburg
Würzburg , 97078, Germany More Info
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Pamela Youde Nethersole Eastern Hospital
Hong Kong , 00852, Hong Kong More Info
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Prince of Wales Hospital
Hong Kong , 99907, Hong Kong More Info
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University of Hong Kong/Queen Mary Hospital
Hong Kong , 99907, Hong Kong More Info
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Queen Elizabeth Hospital
Hong Kong , , Hong Kong More Info
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IRCCS Istituto Oncologico Giovanni Paolo II
Bari , 70124, Italy More Info
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University G. D'Annunzio Chieti
Chieti , 66100, Italy More Info
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Ospedale San Luca
Lucca , 55100, Italy More Info
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IRCCS Istituto Europeo di Oncologia
Milano , 20141, Italy More Info
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Asst Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy More Info
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Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano , 10043, Italy More Info
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Azienda Ospedaliero Universitaria di Parma
Parma , 43126, Italy More Info
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Ospedale Santa Maria della Misericordia
Perugia , 06132, Italy More Info
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IFO Regina Elena
Roma , 00144, Italy More Info
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IRCCS Humanitas Research Hospital
Rozzano , 20089, Italy More Info
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ASST Sette Laghi
Varese , 21100, Italy More Info
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Hyogo Cancer Center
Akashi , 673-8, Japan More Info
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Kyushu University Hospital
Fukuoka , 812-8, Japan More Info
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Saitama Medical University International Medical Center
Hidaka , 350-1, Japan More Info
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Kansai Medical University Hospital
Hirakata , 573-1, Japan More Info
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Iwakuni Clinical Center
Iwakuni , 740-8, Japan More Info
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Izumi City General Hospital
Izumi , 594-0, Japan More Info
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Kanazawa University Hospital
Kanazawa , 920-8, Japan More Info
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The Cancer Institute Hospital of JFCR
Koto-Ku , 135-8, Japan More Info
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Saiseikai Kumamoto Hospital
Kumamoto , 861- , Japan More Info
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Kurashiki Central Hospital
Kurashiki , 710-8, Japan More Info
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Kurume University Hospital
Kurume , 830-0, Japan More Info
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Matsusaka Municipal Hospital
Matsusaka , 515-8, Japan More Info
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NHO Shikoku Cancer Center
Matsuyama , 791-0, Japan More Info
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National Hospital Organization Nagoya Medical Center
Nagoya , 460-0, Japan More Info
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Niigata Cancer Center Hospital
Niigata , 951-8, Japan More Info
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Okayama University Hospital
Okayama , 700-8, Japan More Info
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National Hospital Organization Hokkaido Cancer Center
Sapporo , 003-0, Japan More Info
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Sendai Kousei Hospital
Sendai , 980-0, Japan More Info
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Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo , 113-8, Japan More Info
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Fujita Health University Hospital
Toyoake , 470-1, Japan More Info
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Wakayama Medical University Hospital
Wakayama , 641-8, Japan More Info
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Kindai University Hospital
Ōsaka-sayama , 589-8, Japan More Info
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Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of More Info
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National Cancer Center
Goyang , 10323, Korea, Republic of More Info
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Seoul National University Bundang Hospital
Seongnam , 463-7, Korea, Republic of More Info
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Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
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Severance Hospital
Seoul , 03722, Korea, Republic of More Info
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Asan Medical Center
Seoul , 05505, Korea, Republic of More Info
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Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
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The Catholic University of Korea, Seoul St. Marys Hospital
Seoul , 06591, Korea, Republic of More Info
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Samsung Medical Center
Seoul , 135-7, Korea, Republic of More Info
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Netherlands Cancer Institute
Amsterdam , 1066 , Netherlands More Info
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Rijnstate Ziekenhuis
Arnhem , 6815 , Netherlands More Info
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St. Jansdal Ziekenhuis
Harderwijk , 3844 , Netherlands More Info
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Leiden University Medical Center
Leiden , 2333Z, Netherlands More Info
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Erasmus MC
Rotterdam , 3015 , Netherlands More Info
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University Medical Center Utrecht
Utrecht , 3584 , Netherlands More Info
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Akershus University Hospital
Nordbyhagen , 1478, Norway More Info
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Oslo University Hospital-The Norwegian Radium Hospital
Oslo , 0379, Norway More Info
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Stavanger University Hospital
Stavanger , 8100, Norway More Info
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II Klinika Chorob Pluc i Gruzlicy
Białystok , 15-45, Poland More Info
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Onko-Centrum Sp. z o.o.
Lublin , 20-25, Poland More Info
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Med Polonia Sp. z o.o.
Poznań , 60-69, Poland More Info
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Centro Clinico Champalimaud
Lisboa , 1400-, Portugal More Info
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Instituto Portugues de Oncologio de Lisboa
Lisbon , 1908-, Portugal More Info
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Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio
Porto , 4099-, Portugal More Info
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Centro Hospitalar de Vila Nova de Gaia - Espinho
Porto , 4434-, Portugal More Info
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National University Cancer Institute National University Hospital
Singapore , 11907, Singapore More Info
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National Cancer Centre Singapore NCCS
Singapore , 16961, Singapore More Info
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Tan Tock Seng Hospital
Singapore , 30843, Singapore More Info
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ICON Cancer Centre
Singapore , 32956, Singapore More Info
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Hospital Teresa Herrera C.H.U.A.C.
A Coruña , 15006, Spain More Info
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Hospital del Mar
Barcelona , 08003, Spain More Info
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Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain More Info
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Hospital Clinic i Provincial de Barcelona
Barcelona , 08036, Spain More Info
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Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria
Las Palmas De Gran Canaria , 35016, Spain More Info
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Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain More Info
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MD Anderson Cancer Center
Madrid , 28033, Spain More Info
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Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain More Info
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Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
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Hospital Regional Universitario Malaga
Málaga , 29010, Spain More Info
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Hospital Univeritario Marques de Valdecilla
Santander , 39120, Spain More Info
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Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain More Info
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Hospital Universitario Virgen Macarena
Sevilla , 41071, Spain More Info
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University Hospital Basel
Basel , 4031, Switzerland
Kantonsspital Graubuenden - Hauptstandort
Chur , 7000, Switzerland More Info
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Kantonsspital Winterthur KSW
Winterthur , 8400, Switzerland More Info
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E-Da Hospital
Kaohsiung City , 824, Taiwan More Info
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Taichung Veterans General Hospital
Taichung , 40705, Taiwan More Info
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National Cheng Kung University Hospital NCKUH
Tainan , 704, Taiwan More Info
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National Taiwan University Hospital NTUH
Taipei , 100, Taiwan More Info
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Taipei Veterans General Hospital
Taipei , 11217, Taiwan More Info
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Chang Gung Memorial Hospital-Linkou Branch
Taoyuan , 333, Taiwan More Info
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University Hospital Birmingham NHS Trust
Birmingham , B9 5S, United Kingdom More Info
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Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom More Info
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Leeds Cancer Centre
Leeds , LS9 7, United Kingdom More Info
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University Hospitals of Leicester
Leicester , LE15W, United Kingdom More Info
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Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre
London , EC1A , United Kingdom More Info
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The Royal Marsden Hospital NHS Foundation Trust
London , SW3 6, United Kingdom More Info
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The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom More Info
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The Christie Hospital
Manchester , M20 4, United Kingdom More Info
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The Royal Wolverhampton NHS Trust
Wolverhampton , WV10 , United Kingdom More Info
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

560

Study ID:

NCT05338970

Recruitment Status:

Recruiting

Sponsor:


Daiichi Sankyo, Inc.

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