Spots Global Cancer Trial Database for HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
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Trial Identification
Brief Title: HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
Official Title: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy (HERTHENA-Lung02)
Study ID: NCT05338970
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Highlands Oncology, Springdale, Arkansas, United States
City of Hope, Duarte, California, United States
Moores Cancer Center at the UC San Diego Health, La Jolla, California, United States
Scripps MD Anderson Cancer Center, La Jolla, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Kaiser Permanente - Vallejo Medical Center, Vallejo, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Sarah Cannon/Florida Cancer Specialists - FCS South, Port Charlotte, Florida, United States
Emory University, Atlanta, Georgia, United States
St Luke's Cancer Institute, Boise, Idaho, United States
American Oncology Partners of Maryland, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hackensack Meridian Health-Southern Ocean Medical Center, Manahawkin, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Providence Portland Medical Center, Portland, Oregon, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
The Chris O'Brien Lifehouse, Camperdown, , Australia
St George Public Hospital, Kogarah, , Australia
Liverpool Hospital, Liverpool, , Australia
Austin Hospital, Melbourne, , Australia
St John of God Subiaco Hospital, Subiaco, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Landeskrankenhaus Feldkirch, Feldkirch, , Austria
Medizinische Universitaet Innsbruck, Innsbruck, , Austria
Klinikum Klagenfurt Pulmologie, Klagenfurt, , Austria
Klinikum Wels-Grieskirchen, Wels, , Austria
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf, Wien, , Austria
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
UZ Leuven, Leuven, , Belgium
AZ Sint Maarten Mechelen, Mechelen, , Belgium
AZ Delta, Roeselare, , Belgium
William Osler Health System - Brampton Civic Hospital, Brampton, , Canada
Peking University Cancer Hospital, Beijing, , China
Jilin Cancer Hospital, Chang chun, , China
Hunan Cancer Hospital, Changsha, , China
University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital, Chengdu, , China
National Cancer Center Hospital East, Chibi, , China
Fujian Medical University - Union Hospital Foochow Christian Union Hospital, Fuzhou, , China
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital, Guangzhou, , China
The First Affiliated Hospital Sun-Yat-Sen University, Guangzhou, , China
Pecking University Third Hospital, Haidian, , China
The First Affiliated Hospital of College of Medicine Zhejiang University, Hangzhou, , China
Zhejiang Cancer hospital, Hangzhou, , China
Harbin Medical University - Tumor Hospital The Third Affiliated Hospital, Harbin, , China
The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology, Hefei, , China
Henan Provincial Peoples Hospital, Henan, , China
The Second Affiliated Hospital of Kunming Medical University, Kunming, , China
Lin Yi Cancer Hospital, Linyi, , China
General Hospital of Eastern Theater Command, Nanjing, , China
The First Affiliated Hospital of Guangxi Medical University, Nanning, , China
Fudan University - Shanghai Cancer Center FUSCC, Shanghai, , China
Cancer Hospital of Shantou University Medical College, Shantou, , China
The First Hospital of China Medical University, Shenyang, , China
Union Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH, Wuhan, , China
The First Affiliate Hospital of Xi'an Jiaotong University, Xi'an, , China
Henan Cancer Hospital, Zhengzhou, , China
Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, , China
Hopital Morvan CHU de Brest, Brest, , France
Centre Francois Baclesse, Caen, , France
Centre Francois Baclesse, Caen, , France
Centre Leon Berard, Lyon, , France
Montpellier Cancer Institute ICM, Montpellier, , France
Institut Curie, Paris Cedex 05, , France
APHP - Hopital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou, Rennes, , France
Institut de Cancrologie de lOuest ICO, Saint-Herblain, , France
Gustave Roussy, Villejuif, , France
Universitaetsklinikum Essen, Essen, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
IKF Krankenhaus Nordwest, Frankfurt am main, , Germany
Asklepios Fachklinik Muenchen-Gauting, Gauting, , Germany
Universitatsklinik Giessen und Marburg, Gießen, , Germany
LungenClinic Grosshansdorf, Großhansdorf, , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
LKI Lungenfachklinik Immenhausen, Immenhausen, , Germany
Klinikverbund Allgaeu, Kempten, , Germany
Pius-Hospital Oldenburg, Oldenburg, , Germany
Pamela Youde Nethersole Eastern Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital, Hong Kong, , Hong Kong
University of Hong Kong/Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Elizabeth Hospital, Hong Kong, , Hong Kong
IRCCS Istituto Oncologico Giovanni Paolo II, Bari, , Italy
University G. D'Annunzio Chieti, Chieti, , Italy
Ospedale San Luca, Lucca, , Italy
IRCCS Istituto Europeo di Oncologia, Milano, , Italy
Asst Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Ospedale Santa Maria della Misericordia, Perugia, , Italy
IFO Regina Elena, Roma, , Italy
IRCCS Humanitas Research Hospital, Rozzano, , Italy
ASST Sette Laghi, Varese, , Italy
Hyogo Cancer Center, Akashi, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Saitama Medical University International Medical Center, Hidaka, , Japan
Kansai Medical University Hospital, Hirakata, , Japan
Iwakuni Clinical Center, Iwakuni, , Japan
Izumi City General Hospital, Izumi, , Japan
Kanazawa University Hospital, Kanazawa, , Japan
The Cancer Institute Hospital of JFCR, Koto-Ku, , Japan
Saiseikai Kumamoto Hospital, Kumamoto, , Japan
Kurashiki Central Hospital, Kurashiki, , Japan
Kurume University Hospital, Kurume, , Japan
Matsusaka Municipal Hospital, Matsusaka, , Japan
NHO Shikoku Cancer Center, Matsuyama, , Japan
National Hospital Organization Nagoya Medical Center, Nagoya, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, , Japan
Sendai Kousei Hospital, Sendai, , Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, , Japan
Fujita Health University Hospital, Toyoake, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
Kindai University Hospital, Ōsaka-sayama, , Japan
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
National Cancer Center, Goyang, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Netherlands Cancer Institute, Amsterdam, , Netherlands
Rijnstate Ziekenhuis, Arnhem, , Netherlands
St. Jansdal Ziekenhuis, Harderwijk, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Akershus University Hospital, Nordbyhagen, , Norway
Oslo University Hospital-The Norwegian Radium Hospital, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
II Klinika Chorob Pluc i Gruzlicy, Białystok, , Poland
Onko-Centrum Sp. z o.o., Lublin, , Poland
Med Polonia Sp. z o.o., Poznań, , Poland
Centro Clinico Champalimaud, Lisboa, , Portugal
Instituto Portugues de Oncologio de Lisboa, Lisbon, , Portugal
Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio, Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia - Espinho, Porto, , Portugal
National University Cancer Institute National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore NCCS, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
ICON Cancer Centre, Singapore, , Singapore
Hospital Teresa Herrera C.H.U.A.C., A Coruña, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria, Las Palmas De Gran Canaria, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Regional Universitario Malaga, Málaga, , Spain
Hospital Univeritario Marques de Valdecilla, Santander, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Kantonsspital Graubuenden - Hauptstandort, Chur, , Switzerland
Kantonsspital Winterthur KSW, Winterthur, , Switzerland
E-Da Hospital, Kaohsiung City, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital NCKUH, Tainan, , Taiwan
National Taiwan University Hospital NTUH, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital-Linkou Branch, Taoyuan, , Taiwan
University Hospital Birmingham NHS Trust, Birmingham, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Leeds Cancer Centre, Leeds, , United Kingdom
University Hospitals of Leicester, Leicester, , United Kingdom
Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre, London, , United Kingdom
The Royal Marsden Hospital NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
The Royal Wolverhampton NHS Trust, Wolverhampton, , United Kingdom
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
Name: Clinical Scientist
Affiliation: Daiichi Sankyo
Role: STUDY_CHAIR
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