Spots Global Cancer Trial Database for HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
Official Title: HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT04619004
Study Description
Brief Summary: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.
Detailed Description: This study will initially randomize participants to one of 2 arms in a 1:1 ratio to receive either a 5.6 mg/kg fixed dose regimen or an up-titration dose regimen of patritumab deruxtecan (HER3-DXd, U3-1402).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
City of Hope, Duarte, California, United States
Moores Cancer Center at the UC San Diego Health, La Jolla, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California at Irvine, Orange, California, United States
Cedars Sinai, West Hollywood, California, United States
University of Colorado Denver - Anschutz Medical Campus, Aurora, Colorado, United States
Florida Cancer Specialists - South, Fort Myers, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Memorial Healthcare System, Pembroke Pines, Florida, United States
Florida Cancer Specialist-North, Saint Petersburg, Florida, United States
Florida Cancer Specialists-Panhandle, Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Florida Cancer Specialists-East, West Palm Beach, Florida, United States
Emory University, Dunwoody, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital (MGH) - Hematology/Oncology, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Cancer Institute/Henry Ford Hospital, Detroit, Michigan, United States
Montefiore Medical Center, Bronx, New York, United States
Mount Sinai Hospital, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Cleveland Clinic - Main Campus, Cleveland, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga, Chattanooga, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
Virginia Cancer Specialist, PC, Fairfax, Virginia, United States
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States
Blacktown Hospital, Blacktown, New South Wales, Australia
The Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
St George Public Hospital, Kogarah, New South Wales, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
St John of God Subiaco Hospital, Subiaco, Western Australia, Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf, Wien, , Austria
Universitaire Ziekenhuis Gasthuisberg, Leuven, , Belgium
MHAT Uni Hospital OOD, Panagyurishte, , Bulgaria
Complex Oncological Center - Russe, Russe, , Bulgaria
MHAT Serdika, Sofia, , Bulgaria
Beijing Cancer Hospital, Beijing, , China
Jilin Cancer Hospital, Chang chun, , China
University of Electronic Science & Technology of China (UESTC) - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital, Chengdu, , China
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital, Guangzhou, , China
The First Affiliated Hospital of College of Medicine Zhejiang University, Hangzhou, , China
Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital), Harbin, , China
General Hospital of Eastern Theater Command, Nanjing, , China
Fudan University - Shanghai Cancer Center FUSCC, Shanghai, , China
The First Hospital of China Medical University, Shenyang, , China
Union Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
CHU Toulouse - Hopital Larrey, Toulouse, Haute-Garonne, France
University Hospital of Nantes - Thoracic Oncology, Nantes, Loire-Atlantique, France
Centre Leon Berard, Lyon, Rhone, France
Hopital Morvan CHU de Brest, Brest, , France
Centre Hospitalier Universitaire de Grenoble, Grenoble, , France
Institut Curie, Paris, , France
Hopital Pontchaillou, Rennes, , France
Gustave Roussy, Villejuif, , France
Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim, Köln, Nordrhein-Westfalen, Germany
Universitaet zu Koeln - Uniklinik Koeln, Koeln, North Rhine-Westphal, Germany
LungenClinic Grosshansdorf, Großhansdorf, Schleswig-Holstein, Germany
University Cancer Center, Dresden, , Germany
Universitaet zu Koeln - Uniklinik Koeln, Koeln, , Germany
Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim, Koeln, , Germany
Azienda Ospedaliero Universitaria di Parma, Parma, Province Of Parma, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, Turin, Italy
IRCCS - Istituto Scientifico Romagnolo per lo Studio e La Cura Dei Tumori ISRT, Meldola, , Italy
Fondazione IRCCS Istituto Nazionale Tumori, Milano, , Italy
Humanitas Cancer Center, Rozzano, , Italy
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
National Cancer Center Hospital East, Chiba, Kashiwa-shi, Japan
The Cancer Institute Hospital of JFCR, Ariake, Koto, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
Kindai University Hospital, Ōsaka-sayama, Osaka, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
Niigata Cancer Center Hospital, Chuo Ku Niigata-shi, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, , Japan
Asan Medical Center, Songpa-gu, Seoul, Korea, Republic of
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital, Seoul, , Korea, Republic of
Netherlands Cancer Institute, Amsterdam, , Netherlands
National University Cancer Institute National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore NCCS, Singapore, , Singapore
OncoCare Cancer Centre- Gleneagles Medical Centre, Singapore, , Singapore
Hospital Universitario Virgen Macarena, Sevilla, Andalucia, Spain
Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO, Badalona, Cataluã'a, Spain
Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda, Madrid, Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
START Madrid - Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Regional Universitario Carlos Haya, Málaga, , Spain
Hospital Clinico Universitario Lozano Bleza, Zaragoza, , Spain
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch, Niaosong, Gao Xiong Shi, Taiwan
National Cheng Kung University Hospital, Tainan City, Tai Nan Shi, Taiwan
E-Da Hospital, Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch, Niaosong, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Chung Shan Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital NTUH, Taipei, , Taiwan
MacKay Memorial Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch, Taoyuan, , Taiwan
University Hospital Birmingham NHS Trust, Birmingham, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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