Garrido, Charo http://orcid.org/0009-0002-1257-5066
Manoogian, Melissa
Ghambire, Dhiraj
Lucas, Shawn
Karnoub, Maha
Olson, Matthew T.
Hicks, David G.
Tozbikian, Gary
Prat, Aleix
Ueno, Naoto T.
Modi, Shanu
Feng, Wenqin
Pugh, Judith
Hsu, Ching
Tsurutani, Junji
Cameron, David
Harbeck, Nadia
Fang, Qijun
Khambata-Ford, Shirin
Liu, Xuemin
Inge, Landon J.
Vitazka, Patrik
Funding for this research was provided by:
Daiichi-Sankyo
Article History
Received: 16 August 2023
Revised: 27 September 2023
Accepted: 29 September 2023
First Online: 20 October 2023
Declarations
:
: The DB-04 trial was designed by Daiichi Sankyo, approved by the institutional review board at each site, and conducted in adherence with the International Council for Harmonisation Good Clinical Practice guidelines, the Declaration of Helsinki, and local regulations on the conduct of clinical research. All the patients provided written informed consent before participation in the trial.
: The authors make the following financial disclosures:Charo Garrido, Dhiraj Ghambire, Wenqin Feng, Ching Hsu, Maha Karnoub, and<sup>,</sup> Shirin Khambata-Ford are employees of, and stockholders in Daiichi Sankyo, Inc.At the time of the study, Patrik Vitazka was an employee of, and stockholder in Daiichi Sankyo, Inc.Melissa Manoogian, Shawn Lucas, Matthew T. Olson, Judith Pugh, Qijun Fang, Xuemin Liu, and Landon J. Inge are all employees of Roche Tissue Diagnostics.Shanu Modi: consultancies/advisory boards with AstraZeneca, Daiichi Sankyo, Inc., Eli Lilly and Company, Genentech, GSK, Macrogenics, Novartis, Puma Biotechnologies Inc., Seagen Inc., Zymeworks Inc.. Principal Investigator on clinical trials for AstraZeneca, Daiichi Sankyo, Inc., Seagen Inc., and Genentech.Nadia Harbeck: consultancies/honoraria with Amgen, AstraZeneca, Daiichi Sankyo, Inc., Exact Science, F-Hoffman-la Roche, Lilly Deutschland, Merck, Novartis, Pfizer Pharma GMBH, Pierre Fabre Pharmaceutics, Inc., Sandoz, Seagen Inc. Minority ownership in West German Study GroupDavid Cameron: consultancies for AstraZeneca, Cellgene, Daiichi Sankyo, Inc., Eisai, Eli-Lilly and Company, F-Hoffman-la Roche, GSK, Novartis Pharma, Oncolytics Biotech, Pfizer, prima biomed, Puma, Research Triangle Institute, Sanofi, Seattle Genetics, synthon, Zymeworks Inc. Principal Investigator on clinical trials for Sanofi.Aleix Prat: consultancies for AstraZeneca, Daiichi Sankyo, Inc., F-Hoffman-la Roche, Guardant, Novartis, Oncolytics Biotech, Pfizer Pharam GMBH, Veracyte. Recipient of Research grant from AstraZeneca. Stockholder in Reveal Genomics.Junji Tsurutani: consultancies/honoraria for Daiichi Sankyo, Inc., Eisai Co Ltd, Nippon Kayaku.Naoto T. Ueno: consultant for and recipient of research grant from Daiichi Sankyo, Inc.David G. Hicks: consultancies/honoraria for Daiichi Sankyo, Inc. and AstraZeneca.Gary Tozbikian: consultancies/honoraria for Daiichi Sankyo, Inc. and AstraZeneca.