Lam, Lyn Ley
Pavlakis, Nick
Shitara, Kohei
Sjoquist, Katrin M.
Martin, Andrew J.
Yip, Sonia
Kang, Yoon-Koo
Bang, Yung-Jue
Chen, Li-Tzong
Moehler, Markus
Bekaii-Saab, Tanios
Alcindor, Thierry
O’Callaghan, Christopher J.
Tebbutt, Niall C.
Hague, Wendy
Chan, Howard
Rha, Sun Young
Lee, Keun-Wook
Gebski, Val
Jaworski, Anthony
Zalcberg, John
Price, Timothy
Simes, John
Goldstein, David
Article History
Received: 18 December 2022
Accepted: 14 February 2023
First Online: 22 February 2023
Declarations
:
: INTEGRATE II (Protocol v7.0, 27<sup>th</sup> November 2020) was approved by the Human Research Ethics Committee (Royal North Shore Hospital) of the Northern Sydney Local Health District (NSLHD) as well as individual institutional ethics committees for sites not under NSLHD central ethics approval. The study is performed in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans 2007 (updated 2018), the NHMRC Australian Code for Responsible Conduct of Research 2018 and the principles laid down by the World Medical Assembly in the Declaration of Helsinki 2008. All participants must provide written informed consent to the study procedures before enrolment in the study.
: Not applicable. No data reported.
: A potential competing interest is the provision of study drug regorafenib by BAYER.Kohei Shitara reports receiving personal fees for advisory roles from Lilly, Bristol Myers Squibb, Takeda, Pfizer, Ono Pharmaceutical, Merck Pharmaceutical, Taiho Pharmaceutical, Astellas, Novartis, AbbVie, GlaxoSmithKline, Daiichi Sankyo, Amgen, Boehringer Ingelheim, Guardant Health Japan, and Janssen; receiving honoraria (lecture fee) from Takeda, Bristol-Myers Squibb and Janssen; and receiving research funding from Astellas, Ono Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, Chugai, Merck Pharmaceutical, Medi Science, Eisai and Amgen, outside the submitted work.Keun-Wook Lee reports receiving grants from Ono pharmaceutical, AstraZeneca, Merck Sharp and Dohme, Merck KGaA, Pfizer, BeiGene, Zymeworks, ALX Oncology, Astellas, Macrogenics, Five Prime Therapeutics, Seagen, Bolt therapeutics, Trishula therapeutics, Oncologie, Pharmacyclics, Daiichi Sankyo, Taiho Pharmaceutical, InventisBio, Leap therapeutics, MedPacto, LSK BioPharma, Green Cross Corp, ABLBIO, Y-BIOLOGICS, Genexine, Metafines (to his institution for conducting clinical trials), personal fees from Metafines, Bayer, Daiichi Sankyo, Merck Sharp and Dohme, Bristol Myers Squibb, Vifor Pharma (consultation) and Ono pharmaceutical, Boryung (honorarium) outside the submitted work.Thierry Alcindor reports receiving consulting/advisory fees from Merck, Bayer, BMS, Astrazeneca, Astellas Scientific and Medical Affairs Inc and research funding from epizyme, emd serono, karyopharm therapeutics, springworks therapeutics, astellas pharma and deciphera.Tanios Bekaii-Saab reports receiving research funding to institution from Agios, Arys, Arcus, Atreca, Boston Biomedical, Bayer, Eisai, Celgene, Lilly, Ipsen, Clovis, Seattle Genetics, Genentech, Novartis, Mirati, Merus, Abgenomics, Incyte, Pfizer, BMS; Consulting fees to institution from Ipsen, Arcus, Pfizer, Seattle Genetics, Bayer, Genentech, Incyte, Eisai, Merus, Merck KGA and Merck; personal consulting fees from Stemline, AbbVie, Boehringer Ingelheim, Janssen, Daiichi Sankyo, Natera, TreosBio, Celularity, Caladrius Biosciences, Exact Science, Sobi, Beigene, Kanaph, Astra Zeneca, Deciphera, Zai Labs, MJH Life Sciences, Aptitude Health, Illumina and Foundation Medicine.Katrin Marie Sjoquist reports receiving honororia from AMGEN, BMS, Ipsen, Merck and SERVIER; research funding to institution from Bayer; consulting/advisory role for Competitive Drug Development International.Yung-Jue Bang reports consulting on the advisory board for MSD, Merck Serano, Daiichi-Sankyo, Astellas, Alexo Oncol, Samyang Biopharm, Hanmi, Daewoong and Amgen; receiving research grants from Genentech/Roche, MSD, Merck Serano, Daiichi Sankyo, Astellas and Amgen.The other authors declare they have no competing interests.