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Article History

Received: 18 July 2024

Accepted: 15 October 2024

First Online: 20 November 2024

Declarations

:

: H Iwata has received honoraria and research funding from Pfizer. Y Naito has received honoraria and/or other fees for conference attendance from Chugai, Daiichi Sankyo, and Eli Lilly; received research funds from AbbVie, AstraZeneca, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Eisai, Pfizer, Taiho, and Takeda. M Hattori has received honoraria from Daiichi Sankyo, MSD, and Eli Lilly; received research funding from Konica Minolta. A Yoshimura has nothing to disclose. K Yonemori has received honoraria from Pfizer, Eisai, AstraZeneca, Eli Lilly, Takeda, Chugai, Fuji Film Pharma, PDR pharma, MSD, Boehringer Ingelheim, Ono, Daiichi Sankyo, Bayer, Jansen, Asteras, Bristol Myers Squibb, Novartis, Sanofi, and Merk Biopharma; received research support (to institution) from MSD, Daiichi Sankyo, Merk Biopharma, AstraZeneca, Taiho, Pfizer, Novartis, Takeda, Chugai, Ono, Sanofi, Seattle Genetics, Eisai, Eli Lilly, Genmab, Boehringer Ingelheim, Kyowa Hakko Kirin, Nihon Kayaku, and Haihe. M Aizawa is an employee of Pfizer R&D Japan. Y Mori is an employee of Pfizer R&D Japan and holds stock in Pfizer Inc. J Yoshimitsu is an employee of Pfizer R&D Japan. Y Umeyama is an employee of Pfizer R&D Japan and holds stock in Pfizer Inc. T Mukohara has received honoraria from Daiichi Sankyo, Eli Lilly, Eisai, Pfizer, Novartis, Chugai, AstraZeneca, Kyowa Kirin, and Taiho; received research funds from AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Gilead Sciences, MSD, Novartis, Ono, Pfizer, Sanofi, and Sysmex. Role of the sponsor: The funders had a role in the design and conduct of the study; data collection, management, and analysis of the data. The drafting of the manuscript, review, and decision to submit for publication were made by all the authors.

: Approval of the study protocol by an Institutional Reviewer Board: The protocol, ICF, Investigator Brochure, and other relevant documents were submitted to an IRB/EC by the investigator and reviewed and approved by the IRB/EC before the study was initiated. These IRBs include the following: IRB at Aichi Cancer Center Hospital, IRB at National Cancer Center Hospital East, and IRB at National Cancer Center Hospital. This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines, including the Declaration of Helsinki Council and CIOMS International Ethical Guidelines, applicable ICH GCP Guidelines, applicable ISO 14155 guidelines, medical device guidelines, and other applicable laws and regulations, including privacy laws.

: All patients provided written informed consent prior to the study. Registry and the Registration no. of the study/trial: This study is registered on ClinicalTrials.gov (NCT05463952).

: Not applicable.