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Article History

Received: 8 June 2025

Accepted: 11 August 2025

First Online: 4 September 2025

Declarations

:

: Myung-Ju Ahn declares honoraria from AstraZeneca, Lilly, MSD, Takeda, Amgen, Merck Serono, YUHAN and Daiichi Sankyo/AstraZeneca; consulting or advisory role from AstraZeneca, Lilly, MSD, TAKEDA, Alpha Pharmaceutical, Amgen, Merck Serono, Pfizer, YUHAN, Arcus Ventures and Daiichi Sankyo/AstraZeneca; and research funding from YUHAN. Byoung Chul Cho declares research funding from MOGAM Institute, LG Chem, Oscotec, Interpark Bio Convergence Corp, GIInnovation, GI-Cell, Abion, AbbVie, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Champions Oncology, CJ Bioscience, CJ Blossom Park, Cyrus, Dizal Pharma, Genexine, Janssen, Lilly, MSD, Novartis, Nuvalent, Oncternal, Ono, Regeneron, Dong-A ST, BridgeBio Therapeutics, YUHAN, ImmuneOncia, Illumina, Kanaph Therapeutics, Therapex, JINTSbio, Hanmi, CHA Bundang Medical Center and Vertical Bio AG. Kadoaki Ohashi declares honoraria from Amgen Inc., Boehringer Ingelheim Japan, Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan, Bristol Myers Squibb, Ono Pharmaceutical Co. Ltd., Pfizer Inc., Taiho Pharmaceutical Co., Ltd., MSD K.K. and Novartis Japan; and research funding from Amgen, BeiGene, Chugai Pharmaceutical Co. Ltd., Daiichi-Sankyo, Taiho Pharmaceutical Co., Ltd. and Eli Lilly Japan. Hiroki Izumi declares speaker fees from Takeda, Merck, Ono Pharmaceutical, MSD, Chugai, and Bristol-Myers Squibb Japan; research funding from AbbVie, AstraZeneca, Amgen, Takeda, Eisai and Ono Pharmaceutical; and advisory fees from Amgen. Jong-Seok Lee declares no conflicts of interest. Ji-Youn Han declares consulting fees from AstraZeneca, Amgen, AbbVie, Daiichi Sankyo, LG Chem, Oncovix, Dae Woong, Novartis, Lantern, BMS, Janssen, Merck, Takeda, Pfizer and Roche; honoraria from AstraZeneca, Janssen, Takeda, Merck, Novartis, Pfizer, YUHAN, Takeda and Roche; expert testimony from AstraZeneca; participation in data safety monitoring or on the advisory board for Janssen and AstraZeneca. Chi-Lu Chiang declares honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, Pfizer and Roche. Shuang Huang, Ali Hamidi, Sujoy Mukherjee, and Krista Lin Xu declare employment by and stock ownership in Amgen Inc. Hiraoki Akamatsu declares honoraria from Amgen Inc., AstraZeneca K.K., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo, Eli Lilly Japan K.K., MSD K.K., Nippon Kayaku Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Pfizer Inc., Taiho Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Co. Ltd; advisory role for Amgen Inc., GSK, Janssen Pharmaceutical K.K. and Sandoz; and research funding from Amgen Inc., Chugai Pharmaceutical Co., Ltd., Novartis and MSD K.K.

: DeLLphi-301 was conducted in accordance with the International Council for Harmonisation Good Clinical Practice guidelines and the principles of the Declaration of Helsinki of 1964 and its later amendments. The protocol and amendments were approved by the institutional review board or ethics committee at each participating site (see supplementary appendix for details) and by the regulatory authorities in the participating countries. All patients provided written informed consent. A data review team external to the trial team provided oversight of safety throughout the trial.