246
Participants
Start Date
June 11, 2021
Primary Completion Date
January 31, 2025
Study Completion Date
April 30, 2027
HER3-DXd
Intravenous infusion at a starting dose of 3.2 mg/kg Q3W
HER3-DXd
Intravenous infusion at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)
Osimertinib
Oral administration at 40 mg or 80 mg once daily
Osimertinib
Oral administration at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)
HER3-DXd
Intravenous infusion 5.6 mg/kg Q3W
HER3-DXd
Intravenous infusion 4.8 mg/kg Q3W
Osimertinib
Oral administration at 80 mg once daily
National Taiwan University Hospital, Taipei
Columbia University Irving Medical Center, New York
Memorial Sloan Kettering Cancer Center, New York
Taipei Veterans General Hospital, Taipei
University of Pennsylvania, Philadelphia
Georgetown University Medical Center, Washington D.C.
Virginia Cancer Specialists, PC, Fairfax
Sarah Cannon and HCA Research Institute, Nashville
Chung Shan Medical University Hospital, Taichung
Henry Ford Cancer Institute, Detroit
Northwestern University Feinberg School of Medicine, Chicago
UCLA, Santa Monica
Taipei Medical University Hospital, Taipei
Yale University School of Medicine - Yale-New Haven Hospital, New Haven
Massachusetts General Hospital Cancer Center, Boston
Dana-Farber Cancer Institute, Boston
Dartmouth-Hitchcock Medical Center, Lebanon
National Hospital Organization Shikoku Cancer Center, Matsuyama
National Hospital Organization Kyushu Cancer Center, Fukuoka
National Hospital Organization Hokkaido Cancer Center, Sapporo
Kanagawa Cancer Center, Yokohama
Okayama University Hospital, Okayama
National Cancer Center Hospital, Chuo Ku
National Hospital Organization Iwakuni Clinical Center, Iwakuni-shi
Kindai University Hospital, Ōsaka-sayama
Shizuoka Cancer Center, Shizuoka
The Cancer Institute Hospital of JFCR, Tokyo
Seoul National University Hospital, Seoul
Yonsei University Health System - Severance Hospital, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Lead Sponsor
Collaborators (1)
AstraZeneca
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY