Spots Global Cancer Trial Database for Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
Official Title: A Phase 2, Multicenter, Randomized Study of Trastuzumab Deruxtecan in Subjects With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02)
Study ID: NCT04644237
Conditions
Interventions
Study Description
Brief Summary: This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug.
Detailed Description: This randomized, two-arm, phase 2, multicenter study will evaluate the safety and efficacy of 5.4 mg/kg and 6.4 mg/kg trastuzumab deruxtecan administered every 3 weeks (Q3W) in participants with HER2-mutated metastatic NSCLC. Each participant is expected to receive approximately 14 months of trastuzumab deruxtecan treatment. The primary endpoint of the study will be confirmed objective response rate (blinded independent central review). Secondary endpoints will include, but not limited to, disease control rate, duration of response, progression-free survival, objective response rate (investigator), overall survival, and safety.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Denver - Anschutz Medical Campus, Aurora, Colorado, United States
AdventHealth Orlando, Orlando, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Cancer Institute/Henry Ford Hospital, Detroit, Michigan, United States
University of Michigan, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Virgina Cancer Specialists, Fairfax, Virginia, United States
St John of God Subiaco Hospital, Subiaco, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
University Health Network, Toronto, , Canada
Centre Leon Berard, Lyon, , France
Assistance Publique Hopitaux de Marseille AP-HM, Hopital NORD, Marseille, , France
Hopital Pontchaillou, Rennes, , France
CHU Nantes, Saint-Herblain, , France
CHU toulouse - hôpital Larrey, Toulouse, , France
Gustav Roussy, Villejuif, , France
Ospedale San Luca, Lucca, , Italy
IRCCS Istituto Europeo di Oncologia, Milano, , Italy
SC Oncologia, AOU Policlinico Modena, Modena, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Strutturadi Oncologia, Napoli, , Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, , Italy
Humanitas Cancer Center Istituto Clinico Humanitas, Rozzano, , Italy
Aichi Cancer Center Hospital, Chikusa, , Japan
National Cancer Central Hospital, Chuo Ku, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Okayama University Hospital, Okayama, , Japan
Kindai University Hospital, Ōsaka-sayama, , Japan
Chungbuk National University Hospital, Chungbuk, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Netherlands Cancer Institute, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Chung Shan Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital NCKUH, Tainan, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Chang Gung Memorial Hospital CGMH - LinKou Branch, Taoyuan, , Taiwan
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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