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Article History

Received: 9 March 2024

Accepted: 23 January 2025

First Online: 4 February 2025

Declarations

:

: The PADDLE trial and its biomarker analysis study were approved by the institutional review boards of the participating institutions (Saitama Cancer Center, Chiba Cancer Center, The University of Tokyo Hospital, Cancer Institute Hospital of Japanese Foundation for Cancer Research, National Cancer Center, and Shizuoka Cancer Center). The PADDLE trial is registered at the Japan Registry of Clinical Trials under jRCT2031220448 (date of registration: November. 17, 2022). The biomarker analysis study is registered at the University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) under UMIN000050765. The PADDLE trial will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. The biomarker analysis will be conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects. Appropriate information about the PADDLE trial and its biomarker analysis study is given orally to the patients as well as in a written form. Written informed consent will be obtained from all the patients before enrollment in the trial and its biomarker analysis study.

: Not applicable.

: H.H. has received honoraria from Bristol-Myers Squibb, Chugai Pharmaceutical, Novartis, Taiho Pharmaceutical, Fujifilm Pharmaceuticals, Teijin Pharma, and Ono Pharmaceutical. N.T. has received honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, and Taiho Pharmaceutical. Y.A. has received grants from Ono Pharmaceutical, and Bristol-Myers Squibb. D.T. has received grants from Taiho Pharmaceutical, Ono Pharmaceutical, Eli Lilly, Chugai Pharmaceutical, Bristol-Myers Squibb, and Daiichi Sankyo. C.K.S has received honoraria from Bristol-Myers Squibb, and Ono Pharmaceutical. K.N. has received consulting fees from Senju Pharmaceutical, Toray Industries, and Kowa Company. N.B. has received honoraria from Daiichi Sankyo, Bristol-Myers Squibb, Ono Pharmaceutical, Eli Lilly, and Taiho Pharmaceutical. K.K. has received consulting fees from Ono Pharmaceutical, Bristol-Myers Squibb, BeiGene, Novartis Pharma, AstraZeneca, Roche, Bayer Yakuhin, Merck & Co, Merck Biopharma, and Janssen Pharmaceutical, has received honoraria from Bristol-Myers Squibb, and Ono Pharmaceutical and has participated on a Data Safety Monitoring Board or Advisory Board of Ono Pharmaceutical, Chugai Pharmaceutical, Bristol-Myers Squibb, and Merck & Co. H.S. has received honoraria from Amgen, MSD, and Bristol-Myers Squibb, has participated on a Data Safety Monitoring Board or Advisory Board of Zymworks, MSD, Ono Pharmaceutical, and Astellas Pharma and has received other financial or non-financial interests from Ono Pharmaceutical, Amgen, MSD, Takeda Pharmaceutical Company, AstraZeneca, and Taiho Pharmaceutical. All other authors declare no competing interests.