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Authors
Cruz-Correa, Marcia https://orcid.org/0000-0001-8147-7457
Oh, Do-Youn https://orcid.org/0000-0003-1663-9901
Kato, Ken https://orcid.org/0000-0002-1733-5072
Tabernero, Josep https://orcid.org/0000-0002-2495-8139
Bai, Yuxian
Shi, Jianhua
Lee, Keun-Wook https://orcid.org/0000-0002-8491-703X
Hirano, Hidekazu https://orcid.org/0000-0003-1343-1419
Spigel, David https://orcid.org/0000-0003-3215-9465
Wyrwicz, Lucjan https://orcid.org/0000-0003-0808-6892
Pazo Cid, Roberto https://orcid.org/0000-0002-8026-7391
Cubillo Gracián, Antonio
Xu, Yaling
Sheng, Tao
Yang, Silu
Xu, Rui-Hua https://orcid.org/0000-0001-9771-8534
Moehler, Markus
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Funding
Funding for this research was provided by:
BeOne Medicines, Ltd.
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Article History
Received: 13 August 2025
Accepted: 21 October 2025
First Online: 18 November 2025
Declarations
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: Marcia Cruz Correa has received grants or contracts from BeOne Medicines, Ltd., AbbVie, Genentech, Taiho, Seagen, Bristol Myers Squibb, Merck, Pfizer, Janssen, Mirati, Tempus, Huyabio, Regeneron, and Delfi; has received patents from Johns Hopkins University; and owns stock options in the Pan American Center for Oncology Trials. Do-Youn Oh has received honoraria from AstraZeneca, Novartis, Array Biopharma, Lilly, Servier, BeOne Medicines, Ltd., MSD, and Handok, and has participated on data safety monitoring boards or advisory boards for AstraZeneca, Novartis, Genentech Roche, Merck Serono, Bayer, Taiho, Aslan, Halozyme, Zymeworks, Celgene, Basilea, BeOne Medicines, Ltd., Yunan, Arcus Biosciences, Turning Point Therapeutics, IQVIA, and MSD Oncology. Ken Kato has received consulting fees from AstraZeneca, Bayer, BeOne Medicines, Ltd., Bristol Myers Squibb, Janssen, Merck Bio, Merck & Co., Novartis, Ono, and Roche; has received payment for expert testimony from Bristol Myers Squibb and Ono; and has participated on data safety monitoring boards or advisory boards for Bristol Myers Squibb, Chugai, Merck & Co., and Ono. Josep Tabernero owns stocks in Oniria Therapeutics; has received honoraria from Imedex/HMP, Medscape Education, MJH Life Sciences, and PeerView Institute for Medical Education and Physicians Education; and has received consulting fees from Array Biopharma, AstraZeneca, Bayer, Boehringer Ingelheim, Cardiff Oncology, Chugai, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Genentech, HalioDX SAS, Hutchison MediPharma International, Ikena Oncology, Inspirna Inc, IQVIA, Lilly, Menarini, Merck Serono, Merus, MSD, Mirati, NeoPhore, Novartis, Ona Therapeutics, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Scandion Oncology, Scorpion Therapeutics, Seattle Genetics, Servier, Sotio Biotech, Taiho, TheraMyc, and Tolremo Therapeutics. Yuxian Bai reports no conflicts of interest. Jianhua Shi reports no conflicts of interest. Keun-Wook Lee has received grants or contracts from BeOne Medicines, Ltd., AstraZeneca, Ono Pharmaceutical, Merck Sharp & Dohme, Merck KGaA, Roche, Pfizer, Leap Therapeutics, ALX Oncology, Zymeworks, Astellas, MacroGenics, Amgen, Seagen, Bolt Therapeutics, Trishula Therapeutics, Oncologie, Pharmacyclics, MedPacto, Green Cross Corp, ABLBIO, Y-BIOLOGICS, Daiichi Sankyo, Taiho, InventisBio, Elevar Therapeutics, Metafines, Idience, Genome & Company, and Exelixis. Hidekazu Hirano has received research grants from BeOne Medicines, Ltd., Taiho, Seagen, Amgen, ALX Oncology, and Bristol Myers Squibb, and reports speaker honorarium from Bristol Myers Squibb, Taiho, Novartis, NICHI IKO, Teijin Pharma, and Ono Pharmaceutical. David Spigel reports grants from Genentech/Roche, Novartis, Celgene, Bristol Myers Squibb, Lilly, AstraZeneca, University of Texas of SW Medical Center-Simmons Cancer Center, Merck, G1 Therapeutics, Neon Therapeutics, Nektar, Celldex, Clovis Oncology, Daiichi Sankyo, Astellas Pharma, GRAIL, Transgene, Aeglea Biotherapeutics, Ipsen, BIND Therapeutics, Eisai, ImClone Systems, Janssen Oncology, MedImmune, Agios, GlaxoSmithKline, Tesaro, Cyteir Therapeutics, Novocure, Elevation Oncology, Calithera Biosciences, Arcus Biosciences, Arrys Therapeutics, Bayer, BeOne Medicines, Ltd., Blueprint Medicine, Boehringer Ingelheim, Hutchison MediPharma, Incyte, Kronos Bio, Loxo Oncology, MacroGenics, Molecular Templates, Pure Tech Health, Razor Genomics, Repare Therapeutics, Rgenix, Tizona Therapeutics, Verastem, BioNTech, AbbVie, Amgen, Anheart Therapeutics, Ascendis Pharma, Endeavor BioMedicines, Erasca, Faeth Therapeutics, Fujifilm, Gilead Sciences, Jazz Pharmaceuticals, Lyell Immunopharma, Millennium, Moderna Therapeutics, Monte Rosa Therapeutics, Peloton Therapeutics, Shenzhen Chipscreen Biosciences, Stemline Therapeutics, Synthekine, Taiho Oncology, Tango Therapeutics, Tarveda Therapeutics, Zai Lab, Apollomics, Strata Oncology, and Asher Biotherapeutics; and has received consulting fees from Genentech/Roche, Novartis, Bristol Myers Squibb, AstraZeneca, GlaxoSmithKline, Molecular Templates, Jazz Pharmaceuticals, Sanofi-Aventis, Regeneron, Lilly, BeOne Medicines, Ltd., Ipsen, Monte Rosa Therapeutics, AbbVie, Lyell Immunopharma, and Novocure. Lucjan Wyrwicz has received honoraria from AstraZeneca, BeOne Medicines, Ltd., Bristol Myers Squibb, MSD, Roche, and Servier; has acted as a committee member for Bristol Myers Squibb and Servier; and owns stocks with BeOne Medicines, Ltd. Roberto Pazo Cid has received honoraria from Roche, Astellas, Bristol Myers Squibb, Ipsen, Celgene, and Eisai; has received support for attending meetings and/or travel from Roche, Servier, Lilly, and Bristol Myers Squibb; and has participated on data safety monitoring boards or advisory boards for AstraZeneca, Roche, and Ipsen. Antonio Cubillo Gracián reports no conflicts of interest. Yaling Xu reports no conflicts of interest. Tao Sheng is an employee of Vera Therapeutics, Inc., and reports stocks and previous employment with BeOne Medicines, Ltd. Silu Yang reports employment with BeOne Medicines, Ltd. Rui Hua Xu reports no conflicts of interest. Markus Moehler reports consulting or advisory roles for Bayer, MSD, Merck Serono, Amgen, Taiho, Pfizer, Roche, Lilly, Servier, BeOne Medicines, Ltd., Bristol Myers Squibb, AstraZeneca, Astellas, Dragonfly, and Novartis; reports honoraria from Amgen, Roche/Genentech, Merck Serono, MSD Oncology, Bristol Myers Squibb, AstraZeneca/MedImmune, Servier, Pierre Fabre, Sanofi, Transcenta, Daiichi Sankyo, Astellas, and Nordic; has received grant or research funding from Amgen, Leap Therapeutics, Merck Serono, and MSD; and reports other renumeration from AIO, Amgen, Merck Serono, Roche, Bayer, ASCO, German Cancer Society, MSD, ESMO, BeOne Medicines, Ltd., and EORTC.
: The RATIONALE-305 trial protocol was approved by the relevant institutional review boards and independent ethics committees for each study site. The study was conducted in compliance with Good Clinical Practice guidelines and the principles of the Declaration of Helsinki of 1964. All patients provided written informed consent before participating in the study.
