Conflict of interest

Narikazu Boku disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; and honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, and Taiho Pharma. Takeshi Omori disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Kohei Shitara disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; research funding (to the institution) from Astellas Pharma, Ono Pharmaceutical, Daiichi Sankyo, Taiho Pharma, Chugai, MSD, Amgen, Eisai, PRA Health Sciences, Syneos Health; consulting fees as an advisor from Bristol-Myers Squibb, Takeda, Ono Pharmaceutical, Novartis, Daiichi Sankyo, Amgen, Boehringer Ingelheim, MSD, Astellas, Guardant Health Japan, Janssen, AstraZeneca, Zymeworks, ALX Oncology, and Bayer; and honoraria from Bristol-Myers Squibb, Ono Pharmaceutical, Janssen, Eli Lilly, Astellas, and AstraZeneca. Shinichi Sakuramoto disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Kensei Yamaguchi disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; grants from Taiho Pharma; and honoraria from Daiichi Sankyo, Chugai Pharmaceutical, Bristol-Myers Squibb, Eli Lilly, Taiho Pharma, Takeda, and Merck Biopharm. Ken Kato disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; consulting fees from Ono Pharmaceutical, Bristol-Myers Squibb, BeiGene/Novartis, AstraZeneca, Roche, Bayer, Merck & Co, Merck Bio, and Janssen; honoraria from Ono Pharmaceutical and Bristol-Myers Squibb; and payments for expert testimony from Ono Pharmaceutical and Bristol-Myers Squibb. Shigenori Kadowaki disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; research grants from Bristol-Myers Squibb, Ono Pharmaceutical, Bayer, Daiichi Sankyo, MSD, Chugai, Janssen, Nobelpharma, and Eli Lilly; and honoraria from Bristol-Myers Squibb, Ono Pharmaceutical, Bayer, Taiho Pharma, Eisai, Daiichi Sankyo, MSD, Chugai, and Otsuka Pharmaceutical. Kunihiro Tsuji disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Min-Hee Ryu disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; research grants from AstraZeneca; consulting fees from Ono Pharmaceutical, Bristol-Myers Squibb, MSD, Eli Lilly, Taiho Pharma, Novartis, Daiichi Sankyo, AstraZeneca, Astellas, and Daehwa; and payments or honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, MSD, Eli Lilly, Taiho Pharma, Novartis, and Daehwa. Do-Youn Oh disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; research grants from AstraZeneca, Novartis, Array, Eli Lilly, Servier, BeiGene, MSD, and Handok; and participation on data safety monitoring boards or advisory boards for AstraZeneca, Novartis, Genentech/Roche, Merck Serono, Bayer, Taiho Pharma, ASLAN, Halozyme, Zymeworks, Bristol-Myers Squibb, Celgene, BeiGene, Basilea, Turning Point, Yuhan, Arcus Biosciences, IQVIA, and MSD. Sang Cheul Oh disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Sun Young Rha disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; grants (to the institution) from AstraZeneca, Ono Pharmaceutical, Eisai, Ipsen, MSD, Merck KGaA, Pfizer, BeiGene, Astellas Pharma, AMGEN, ALX Oncology, Zymeworks, Macrogenics, Seagen, Bold Therapeutics, MedPacto, ABLBIO, Daiichi Sankyo, Taiho Pharmaceutical, Leap therapeutics, and Arcus Biosciences for conducting clinical trials; consulting fees from LG Biochem and Indivumed; personal fees/honoraria from MSD, Eli Lilly, Daiichi Sankyo, Eisai, and Ipsen; and participation on data safety monitoring boards or advisory boards for Amgen and Toray. Keun-Wook Lee disclosed institutional research funding (to the institution) from Ono Pharmaceutical for conducting clinical trials; research funding (to the institution) for conducting clinical trials from AstraZeneca, MSD, Merck KGaA, Roche, BeiGene, Leap therapeutics, ALX Oncology, Zymeworks, Astellas, Macrogenics, Amgen, Seagen, Bolt Therapeutics, Trishula Therapeutics, MedPacto, Green Cross Corp, Y-BIOLOGICS, Daiichi Sankyo, Taiho Phama, InventisBio, Elevar Therapeutics, Metafines, Idience, Genome & Company, and Exelixis; honoraria for lectures from Ono Pharmaceutical, Boryung, Daiichi Sankyo, Astellas, and Sanofi-Aventis; and participation on data safety monitoring boards or advisory boards for ALX Oncology and Metafines. Ik-Joo Chung disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Sun Jin Sym disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Li-Tzong Chen disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; grants (to the institution) from MSD; consulting fees from AstraZeneca and MSD; honoraria from AstraZeneca, MSD, Ono Pharmaceutical, and Bristol-Myers Squibb; participation on data safety monitoring boards or advisory boards for AstraZeneca and MSD; and receipt of study drugs (to the institute) from Ono Pharmaceutical, Bristol-Myers Squibb, and Boehringer Ingelheim. Jen-Shi Chen disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Li-Yuan Bai disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial. Takashi Nakada is an employee of Ono Pharmaceutical. Shunsuke Hagihara is an employee of Ono Pharmaceutical. Reina Makino is an employee of Ono Pharmaceutical. Eiji Nishiyama is an employee of Ono Pharmaceutical. Yoon-Koo Kang disclosed research funding (to the institution) from Ono Pharmaceutical for this clinical trial; medical writing support from Astellas Pharma; and consulting fees from Amgen, Novartis, Roche, Daehwa, Zymeworks, Blueprint, Surface Oncology, ALX Oncology, Macrogenics, Bristol-Myers Squibb, Merck, and Liscure.

Ethical approval and consent to participate

This trial was approved by the institutional review board/ethics committee at each participating site and adhered to the Declaration of Helsinki and Good Clinical Practice. All patients provided written informed consent to participate in the trial.