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Article History

Received: 3 July 2020

Accepted: 9 December 2020

First Online: 15 January 2021

Ethics approval and consent to participate

: The study was performed in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guideline (ICH) for Good Clinical Practice (GCP). The Independent Ethics Committee (NRES Committee North East, Sunderland, UK) of the coordinating investigator of the trial (Dr Peter Schmid, London, UK) gave a favourable opinion for the study. The IECs and/or IRBs met the requirements of the ICH GCP and local legislation. The Medicines and Healthcare products Regulatory Agency (MHRA) approved the trial on 17 March 2014.

: Not applicable

: PS declares an advisory council or committee role for Pfizer, AstraZeneca, Novartis, Roche/Genentech, MSD, Boehringer Ingelheim, Bayer, Eisai, Celgene, and Puma; has received honoraria and consulting fees from Pfizer, AstraZeneca, Novartis, Roche/Genentech, Merck, Boehringer Ingelheim, Bayer, Eisai, Celgene, and Puma; and has received grants or research funds for his institution from AstraZeneca, Roche, Genentech, Oncogenex, Novartis, and Astellas.JB declares that his institute received payments from Boehringer Ingelheim for conducting this trial, and his institutes (Karolinska University Hospital and/or Karolinska Institutet) have received unrestricted research grants to perform academic clinical studies/spin-off studies from Amgen, AstraZeneca, Bayer HealthCare, Merck, Roche, Pfizer, and Sanofi Aventis.S-AI declares an advisory council or committee role for AstraZeneca, Hanmi, Novartis, MediPacto, Roche, and Pfizer; has received consulting fees from AstraZeneca, Amgen, Hanmi, Novartis, MediPacto, Eisai, Roche, and Pfizer; and has received grants or research funds from AstraZeneca, Roche, and Pfizer.Y-SL declares an advisory council or committee role for Boehringer Ingelheim and Novartis; has received honoraria from Novartis, Pfizer, Roche, Merck Sharp & Dohme, and Eisai; has received consulting fees from Novartis, Pfizer, Roche, and Merck Sharp; has received grants or research funds from Novartis and Roche, and grants from Merck Sharp & Dohme; and has received travel grants or lecture fees from Novartis, Pfizer, Roche, Merck Sharp & Dohme, and Eisai.NM declares an advisory council or committee role for Eisai, AstraZeneca, Roche, Pfizer, and Novartis.PN declares an advisory council or committee role and has received consulting fees (with payment to his institution) for Novartis, Pfizer, and Eli Lilly; he has received grants or research funds from Kom op Tegen Kanker Fund.KSL has received consulting fees from Roche, Lilly, and Novartis and has received grants or research funds from Dong-A ST.JAP-F is a member of a Steering Committee for two trials for AstraZeneca and Karyopharm; has received honoraria from AstraZeneca, Tesaro, Pharmamar, Roche, and Gilead; and has received consulting fees from AstraZeneca, Clovis, Roche, and Tesaro.DA declares research funding from Boehringer Ingelheim and Roche.AG declares receipt of travel grants from Roche, Novartis, Pfizer, and AstraZeneca.AP declares advisory council or committee roles for Nanostring Technologies, Roche, Novartis, Pfizer, Oncoloytics Biotech, Amgen, Lilly, MSD, PUMA, and Daiichi Sankyo, Inc, and grants or research funds from Nanostring Technologies, Roche, and Novartis.GJ declares honoraria from Novartis, Roche, Lilly, Pfizer, Amgen, and Bristol-Myers Squibb; an advisory role for Novartis, Roche, Amgen, Pfizer, Bristol-Myers Squibb, Lilly, AstraZeneca, Daiichi Sankyo, and Abbvie; research funding from Roche and Pfizer; and travel, accommodation, or expenses from Novartis, Roche, Pfizer, and Lilly.LS is employed on behalf of Boehringer Ingelheim.R-ME and DC-LH are employees of Boehringer Ingelheim.TB is a former employee of Boehringer Ingelheim and holds a patent for xentuzumab.JC declares employment and ownership of stock/shares with Oncomark Limited; is on the Board of Directors for Cancer Clinical Research Trust and Cancer Trials Ireland; has received honoraria from Eisai, Amgen, Puma Biotechnology, Seattle Genetics, Boehringer Ingelheim, Pfizer, Vertex Pharmaceuticals, Genomic Health, G1 therapeutics, AstraZeneca, Roche, MSD Oncology, and Pierre Fabre; has a consulting or advisory role with Eisai, Puma Biotechnology, Boehringer Ingelheim, Pfizer, Vertex Pharmaceuticals, Roche, Seattle Genetics, and Novartis; is part of the Speaker’s bureau for Pfizer, Eisai, and Genomic Health; has received research funding from Roche, Eisai, Boehringer Ingelheim, and Puma Biotechnology; and has received travel, accommodation, and expenses from MSD, Pfizer, Roche, AstraZeneca, Abbvie, Novartis, and Pierre Fabre.JCo is a consultant/advisor for Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck Sharp & Dohme, GSK, and Leuko; has received honoraria from Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp & Dohme, and Daiichi Sankyo; has received research funding to his institution from Roche, Aria Pharmaceuticals, AstraZeneca, Baxalta, GMBH/Servier Affaires, Bayer HealthCare, Eisai, F Hoffman-La Roche, Guardant Health, Merck Sharp & Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London, and Seagen; and holds stock, patents, or intellectual property with MedSIR.M-PS and SM have no conflicts of interest to declare.