Macaulay, Valentine M. http://orcid.org/0000-0001-8659-0192
Lord, Simon http://orcid.org/0000-0001-7946-5609
Hussain, Syed http://orcid.org/0000-0003-1552-511X
Maroto, José Pablo
Jones, Robert Hugh
Climent, Miguel Ángel
Cook, Natalie http://orcid.org/0000-0003-2606-1082
Lin, Chia-Chi
Wang, Shian-Shiang
Bianchini, Diletta
Bailey, Mark
Schlieker, Laura
Bogenrieder, Thomas
de Bono, Johann
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Received: 25 January 2023
Revised: 10 July 2023
Accepted: 25 July 2023
First Online: 3 August 2023
Competing interests
: VMM reports consulting or advisory role for Boehringer Ingelheim. SH reports consulting or advisory role for Pierre Fabre, Bayer, Janssen Oncology, Roche, Merck, Bristol-Myers Squibb, AstraZeneca, Pfizer, GlaxoSmithKline; research funding from Boehringer Ingelheim, Janssen-Cilag, Pierre Fabre; and travel, accommodations, expenses from Janssen-Cilag, Bayer, Boehringer Ingelheim, Pierre Fabre, Pfizer, Roche, MSD Oncology. JPM has received honoraria for consulting or advisory role from Sanofi, Janssen, Astellas, and Bayer. MÁC reports consulting role for BMS, MSD, Bayer, EUNSA, Pfizer, Roche, Janssen, Pierre Fabre, Ipsen; honoraria from BMS, Astellas, Janssen, MSD, Sanofi, Bayer, Roche, Pfizer, Novartis, Ipsen; travel/accommodation expenses from Janssen, Astellas, Roche, Ipsen, MSD. NC has received institutional research funding from Roche, AstraZeneca, Redx, Janssen, Pfizer, Taiho, Eisai, Avacta, UCB, Starpharma, Boehringer, Stemline, and Orion; and has participated on a data safety monitoring board or advisory board for Roche, RedX Pharmaceuticals, and Jannsen. C-CL reports receiving personal fees from AbbVie, Bayer, BeiGene, Blueprint Medicines, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Merck KGaA, Novartis, PharmaEngine, and Roche. DB reports personal fees from Pfizer and Janssen. MB, LS and TB report being employees of Boehringer Ingelheim. JdB has received personal fees and travel expenses for serving as an advisor for Amgen, Astellas, AstraZeneca, Bayer, BioXcel Therapeutics, Boehringer Ingelheim, CellCentric, Daiichi, Eisai, Roche/Genentech, Genmab, GlaxoSmithKline, Harpoon, Janssen, Menarini Silicon Biosystems, Merck Serono, Merck Sharp & Dohme, Orion Pharma, Pfizer Inc., Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Terumo, and Vertex Pharmaceuticals; has received grants paid to his institution from Astellas, AstraZeneca, Bayer, CellCentric, Daiichi, Roche/Genentech, Genmab, GlaxoSmithKline, Harpoon, Janssen, Merck Serono, Merck Sharp & Dohme, Orion Pharma, Pfizer Inc., Sanofi Aventis, Sierra Oncology, Taiho, and Vertex Pharmaceuticals; and holds patents WO 2005 053662 licensed to AstraZeneca and US5604213 licensed to Janssen, for which he receives no personal income. SL, RHJ and S-SW declare no competing interests.
: The trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The protocol was approved by the independent ethics committees (IECs) and institutional review boards of the participating centres The IEC (National Research Ethics Service Committee London – Chelsea Research Ethics Committee Bristol Centre, Bristol, United Kingdom) of the Coordinating Investigator gave a favourable opinion for the study on 14 August 2014. All patients provided written informed consent.