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Article History

Received: 26 June 2024

Accepted: 3 October 2024

First Online: 20 October 2024

Declarations

:

: The authors declare the following competing interests: N.H. has received lecture honoraria from Art Tempi, AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Medscape, MSD, Novartis, Onkowissen, Pierre Fabre, Roche, Sanofi, Seagen, Viatris, and Zuelligpharma; has received consulting or advisory honoraria from Aptitude Health, Gilead, Pfizer, Sandox-Hexal, Sanofi, and Seagen; has received research funding from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Gilead, MSD, Roche, Seagen, TRIO, and WSG; has participated on IDMC/steering committees for Lilly, Pierre Fabre, and Roche; and has ownership interest in the West German Study Group. E.C. has received lecture, consulting, or advisory honoraria from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, Menarini, MSD, Novartis, Pfizer, Reveal Genomics, and Roche; has received support for attending meetings and/or travel from AstraZeneca, Pfizer, and Roche; has received research funding from Daiichi Sankyo, Pfizer, and Roche; and has participated on steering committees for AstraZeneca, Daiichi Sankyo, Gilead, Novartis, Reveal Genomics, and Roche. G.J. has received consulting honoraria from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Diaccurate, Lilly, Novartis, Pfizer, Roche, and Seagen; has received honoraria from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Lilly, Novartis, Pfizer, Roche, and Seagen; has received support for attending meetings and/or travel from Amgen, AstraZeneca Bristol Myers Squibb, Gilead, Lilly, Novartis, Pfizer, and Roche; and has received medical writing support from Amgen, AstraZeneca, Bristol Myers Squibb, Lilly, Novartis, and Roche. V.M. has received lecture honoraria from AstraZeneca, Daiichi Sankyo, Eisai, Gilead, high5 Oncology, iMED Institut, Lilly, Medac, Medscape, MSD, Novartis, Onkowissen, Pfizer, Pierre Fabre, Roche, and Seagen; has received consulting or advisory honoraria from ClinSol, Daiichi Sankyo, Eisai, Gilead, Lilly, MSD, Novartis, Pierre Fabre, PINK, Roche, and Stemline; and has received research funding from AstraZeneca, Genentech, Novartis, Roche, and Seagen. N.N. has received consulting or advisory honoraria from AstraZeneca, Chugai Pharmaceutical, and Daiichi Sankyo; has received lecture honoraria from AstraZeneca, Chugai Pharmaceutical, Eisai, Daiichi Sankyo, Eli Lilly Japan, Nippon Kayaku, and Pfizer Japan; and has received research funding from Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Nippon Kayaku, and Pfizer Japan. G.V. has received research grants from Dako/Agilent Technologies, Roche/Genentech, and Ventana Medical Systems, and has received honoraria from AstraZeneca, Daiichi Sankyo, Dako/Agilent, Gilead, MSD Oncology, Pfizer, Roche, and Ventana. R.B. has held advisory roles at AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Grünenthal, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Seagen, and Stemline; has received lecture honoraria from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Grünenthal, MSD, Novartis, Pfizer, Pierre Fabre, Roche, Seagen, and Stemline; and has received research support from Daiichi Sankyo, MSD, Novartis, and Roche. C.K. has received lecture honoraria from AstraZeneca, Eli Lilly, Genomic Health, Gilead, GSK, Novartis, PharmaMar, Pfizer, and Roche; has received consulting or advisory honoraria from AstraZeneca, Eli Lilly, Genomic Health, Gilead, GSK, MSD, Novartis, PharmaMar, and Roche; and has participated on steering committees for AstraZeneca. M.J.H. has received lecture honoraria from AstraZeneca. R.M.C. has received an unrestricted educational grant from Pfizer; has received research support from AstraZeneca, Daiichi Sankyo, MSD Ireland, and Pfizer; has received honoraria from AstraZeneca, Daiichi Sankyo, Gilead, Lilly, and Seagen; and has received support for attending meetings and/or travel from Gilead, Novartis, and Roche. M.G. has received support for attending meetings and/or travel from AstraZeneca, Gilead, Roche, and Pfizer, and has received honoraria from AstraZeneca, Gilead, and Pfizer. V.G. has received honoraria from AstraZeneca, Daiichi Sankyo, Eli Lilly, Exact Sciences, Gilead, Menarini Stemline, MSD, Novartis, Pfizer, Olema Oncology, Pierre Fabre, and Roche; has received lecture honoraria from AstraZeneca, Daiichi Sankyo, Eli Lilly, Exact Sciences, Gilead, GSK, Menarini Stemline, Novartis, Roche, and Zentiva; and has received expert testimony honoraria from Eli Lilly. G.B. has received honoraria from Agendia, Amgen, AstraZeneca, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Exact Science, Gilead, Helsinn Lilly, Menarini Stemline, MSD, Novartis, Pfizer, Roche, Sanofi, and Seagen, and has received a research grant from Gilead. H.W. has received lecture honoraria from Seagen; has received consulting or advisory honoraria from AstraZeneca, Augustine Therapeutics, Daiichi Sankyo, E Squared Communications LLC, Gilead, Immutep Ltd, Lilly, MediMix, Novartis, NV Hict, Pfizer, PSI CRO, Roche, and Stemline Therapeutics; has received support for attending meetings and/or travel from Daiichi Sankyo and Pfizer; has received research funding from Novartis, Roche, and Syneos Health; and has received subscription fees from Gilead. S.E.-d-R. has received honoraria from AstraZeneca, COR2ED, Daiichi Sankyo, Jazz Pharmaceuticals, Medistream, Pierre Fabre, Roche, and Seagen; has received research funding from AstraZeneca, Byondis, Daiichi Sankyo, Jazz Pharmaceuticals, MEDSIR, Roche, SOLTI, and Zymeworks; and has received support for attending meetings and/or travel from AstraZeneca, Daiichi Sankyo, Kern Pharma, Pfizer, Seagen, and SOLTI. M.P., H.B., N.K.-C., N.S., and S.V. are employees of AstraZeneca. N.K.-C. holds stocks in AstraZeneca and AbbVie. N.U.L. has received honoraria from AstraZeneca and has received research funding from AstraZeneca. The remaining authors declare no competing interests.

: The study protocol was approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS Comitato Etico, Medizinische Ethikkommission an der Julius-Maximilians-Universität Würzburg (for University Hospital Wurzburg and Vivantes Hospital Group), HRA and Health and Care Research Wales (for Leeds Teaching Hospitals Trust and NHS Lothian, UK), CEIM Provincial de Málaga (for Unidad de Gestión Clínica Intercentros Oncology, Spain), and Comite de Revue Interne Data (for Institut Curie, France; study MR-004 compliant).

: Not applicable.

: Not applicable.