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Article History

Received: 25 January 2019

Accepted: 27 May 2019

First Online: 31 May 2019

Ethics approval and consent to participate

: This study was conducted in accordance with the principles expressed in the Declaration of Helsinki. The main protocol of this study was approved by the institutional review board of Shizuoka Cancer Center (Trial No. 29–12–29-1-5) at August 22, 2017. Protocol amendments have been made in the study period and the list of participating institutions. The latest version (version 4.0) of study protocol have been reviewed and approved by the institutional review board in each participating hospital (Additional file ). The latest version of this protocol was approved by each participant site. Written informed consent will be obtained from all the participants. Consents for the ancillary translational research are obtained separately.

: Not applicable.

: SM has received lecture fees from Chugai Pharmaceutical, Bristol-Myers Squibb, MSD, Chugai Pharmaceutical and Eli Lilly Japan. SM has received research funding from Bayer Yakuhin, Chugai Pharmaceutical, Merck Serono, ASLAN Pharmaceuticals, TORAY, Ono Pharmaceutical, and Sumitomo Dainippon Pharma, Ajinomoto Corporation. TT has received lecture fees from AstraZeneca, Chugai Pharmaceutical, and Eli Lilly Japan. TT has also received research funding from Ono Pharmaceutical, MSD, AstraZeneca, Chugai Pharmaceutical, Eli Lilly Japan, and Pfizer. AI has received lecture fees from Kracie Pharma Ltd. and research funding from Kracie Pharma, Ltd. and Saisei Mirai Clinics. KT has received lecture fees from Ono Pharmaceutical, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, Boehringer-Ingelheim, MSD, Daiichi-Sankyo, and Pfizer. KT has also received research funding from Ono Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, and Boehringer-Ingelheim. The other authors declare that they have no competing interests.