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Article History

Received: 2 September 2025

Accepted: 14 October 2025

First Online: 3 November 2025

Declarations

:

: Rachel E. Sanborn received honoraria from Illumina; served in a consulting or advisory role for AbbVie, Amgen, AstraZeneca, BeiGene, Boehringer Ingelheim, Curio Science, Daiichi Sankyo, GE HealthCare, Gilead, GSK, IDEOlogy Health, Inhibrx, Eli Lilly, Johnson & Johnson, MJH Life Sciences, OncLive, Pfizer, Sanofi-Aventis, and Ose Immunotherapeutics; received research funding from Merck and AstraZeneca (investigator-sponsored trials); and received travel support to a scientific meeting from HotSpot Therapeutics. Caicun Zhou received honoraria from Eli Lilly China, Sanofi, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu Pharmaceuticals, Jiangsu Hengrui Pharmaceuticals, Innovent Biologics, Alice Pharmaceuticals, C-Stone Pharmaceuticals, LUYE Pharma, TopAlliance Biosciences Inc., Amoy Diagnostics, and AnHeart Therapeutics; and served in a consulting or advisory role for Innovent Biologics, Qilu Pharmaceuticals, Jiangsu Hengrui Pharmaceuticals, and TopAlliance Biosciences Inc. Ke-Jing Tang has no conflicts of interest that are directly relevant to the content of this article. Byoung Chul Cho received research funding from AstraZeneca, Champions Oncology, CJ Bioscience, Johnson & Johnson, Merck Sharp & Dohme, Dong-A ST, Yuhan Corporation, ImmuneOncia, Therapex, J INTS BIO, Vertical Bio AG, GI Innovation, and Cyrus Therapeutics; received royalties or licenses from Champions Oncology, Crown Bioscience, Imagen, and PearlRiver Bio GmbH; served in a consulting or advisory role for BeiGene, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Bristol Myers Squibb, CJ Bioscience, Cyrus Therapeutics, Ono Pharmaceutical, Yuhan Corporation, Pfizer, Eli Lilly, Guardant Health, Takeda, Merck Sharp & Dohme, Janssen, Gilead, Amgen, Daiichi Sankyo, Regeneron, Sanofi, AnHeart Therapeutics, Seagen, Harpoon Therapeutics, GSK, ArriVent Biopharma, BridgeBio, Kanaph Therapeutics, Cyrus Therapeutics, J INTS BIO, and Therapex; served in a leadership role for J INTS BIO; has stock ownership or other ownership interests with Theravance, Gencurix, BridgeBio, Kanaph Therapeutics, Cyrus Therapeutics, Interpark Bio, Convergence Corp, and J INTS BIO; reports employment with Yonsei University Health System; and other relationships with DAAN Biotherapeutics. Susanne Cheng served in an advisory role for Merck and AstraZeneca. Sanjay Popat served on advisory boards for Boehringer Ingelheim, Novartis, Amgen, Johnson & Johnson, Daiichi Sankyo, AstraZeneca, Bayer, Bristol Myers Squibb, Blueprint Medicines, Merck Serono, Guardant Health, BeiGene, Takeda, Eli Lilly, Roche, Turning Point Therapeutics, GSK, Merck Sharp & Dohme, Pfizer, Sanofi, and EQRx; served as an invited speaker for Medscape and VJOncology; has other relationships with Elsevier, Amgen, Merck Sharpe & Dohme, and Blueprint Medicines; served as a coordinating PI for ARIAD Pharmaceuticals, Boehringer Ingelheim, Celgene, Takeda, Turning Point Therapeutics, Roche, Johnson & Johnson, Bristol Myers Squibb, and Eli Lilly; served as a local PI for AstraZeneca, Roche, GSK, and Trizell; received research grants from Guardant Health; served in a leadership role for the British Thoracic Oncology Group and European Thoracic Oncology Platform; served in an advisory role for ALK Positive UK, International Association for the Study of Lung Cancer, Lung Cancer Europe, and the Ruth Strauss Foundation; served as an officer for the European Society of Medical Oncology; and served as a member of the board of directors for the Mesothelioma Applied Research Foundation. Akira Ono received payment or honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co., Janssen Pharmaceutical K.K., Indica Labs, and Ono Pharmaceutical and research grants to their institution from AstraZeneca K.K., Chugai Pharmaceutical Co., and Janssen Pharmaceutical K.K. Shun Lu received consulting fees from AstraZeneca, Pfizer, Boehringer Ingelheim, HUTCHMED, Simcere Pharmaceutical, Zai Lab, GenomiCare, Yuhan Corporation, Roche, Menarini, and InventisBio Co. Ltd. and received honoraria from AstraZeneca, Roche, Hansoh Pharma, Jiangsu Hengrui Pharmaceuticals, HUTCHMED, Bristol Myers Squibb, BeiGene, and Eli Lilly. Margarita Majem received research funding from Roche, Bristol Myers Squibb, and AstraZeneca; received honoraria from Roche, AstraZeneca, MSD Oncology, Amgen, Bristol Myers Squibb, Pierre Fabre, Casen Recordati, Immedica, Johnson & Johnson, Novartis, Sanofi, Takeda, Pfizer, BeiGene, and Boehringer Ingelheim; received support for travel from Pfizer, Merck Sharp & Dohme, Roche, AstraZeneca, and Johnson & Johnson. Andres Aguilar received honoraria from Johnson & Johnson, Spain, Takeda, and Roche-Farma S.A.; and received support for travel from Merck Sharp & Dohme, Johnson & Johnson, Roche-Farma S.A., and Bristol Myers Squibb. Maria Del Rosario Garcia Campelo served in a consulting or advisory role for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, MSD Oncology, Novartis, Pfizer, Roche/Genentech, and Takeda; served on a speakers bureau for Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, Eli Lilly, MSD Oncology, Novartis, Pfizer, Roche, Sanofi/Aventis, and Takeda; and received travel, accommodations, or expenses from MSD Oncology, Pfizer, and Roche/Genentech. Hidetoshi Hayashi received honoraria from Ono Pharmaceutical, Daiichi Sankyo, AstraZeneca K.K., Chugai Pharmaceutical Co., Eli Lilly Japan, Merck Sharp & Dohme K.K., Pfizer Japan, Nippon Boehringer Ingelheim, Merck, 3H Medi Solution, Novartis K.K., Bristol Myers Squibb, Amgen, Sysmex, and Takeda; received a manuscript fee from Guardant Health Japan; received research funding from IQVIA Services Japan K.K., Syneos Health K.K., EPS Corporation, Nippon Kayaku, Takeda, Merck Sharp & Dohme K.K., Amgen, Taiho Pharma, Bristol Myers Squibb, Janssen K.K., CMIC, Pfizer R&D Japan, Labcorp Development Japan K.K., Kobayashi Pharmaceutical, Pfizer Japan, Eisai, EP-CRSU CO, Shionogi, Otsuka, GSK K.K., Sanofi K.K., Chugai Pharmaceutical Co., Nippon Boehringer Ingelheim, SRL Medisearch Inc., PRA Health Sciences, Astellas, Ascent Development Services, Eisai, and Bayer; and has other relationships with Medical Review Co, Japanese Board of Cancer Therapy, and Japanese Society of Medical Oncology. Kang-yun Lee has no conflicts of interest that are directly relevant to the content of his article. Se-Hoon Lee served in a consulting or advisory role for Abion, AstraZeneca, BeiGene, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, IMBdx, ImmuneOncia, Johnson & Johnson, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and Takeda; received honoraria from Amgen, AstraZeneca/MedImmune, Bristol Myers Squibb, Merck Sharp & Dohme, Roche, and Yuhan Corporation; and received research funding from AstraZeneca, Daiichi Sankyo, Lunit, and Merck Sharp & Dohme. Angelo Delmonte served in an advisory role for Takeda, Novartis, AstraZeneca, Merck Sharp & Dohme, and Pfizer. Jorge Alatorre-Alexander received honoraria from AstraZeneca, Bristol Myers Squibb (Mexico), and Roche/Genentech; served in a consulting or advisory role for AstraZeneca, Bristol Myers Squibb, MSD Oncology, Novartis, and Roche/Genentech; served on a speakers bureau for AstraZeneca, Merck Sharp & Dohme, and Roche/Genentech; and received travel, accommodations, or expenses from AstraZeneca and Roche. Gary Richardson received research funding from Bristol Myers Squibb, Roche/Genentech, AstraZeneca, Merck, Takeda, BeiGene, Pfizer, CBT Pharmaceuticals, Corvus Pharmaceuticals, Novotech, Shanghai Fosun Pharmaceutical Development Co, Henlius, Five Prime Therapeutics, Alphamab Co., Boehringer Ingelheim, Adagene, Bio-Thera Solutions, ChemoCentryx, Curon BioPharma, D3 Bio, InventisBio Co. Ltd., Senz Oncology, GenFleet Therapeutics, GeneQuantum, Henlius, Keythera Pharma, LaNova Australia Pty Limited, Medicenna Therapeutics, Minghui Pharmaceutical, Neoleukin Therapeutics, PharmAbcine, RemeGen, Seagen, Surface Oncology, Eucure Biopharma, Janssen Oncology, ImmunGen, Imugene, Therapim, Zentalis, and Agenus. Victor Santos received honoraria from AstraZeneca, Bristol Myers Squibb Brazil, Daiichi Sankyo, GSK, Ipsen, Janssen, and Merck Sharp & Dohme; served in a consulting or advisory role for Johnson & Johnson; and received travel, accommodations, or expenses from Janssen. Christophe Dooms served on an advisory board for Janssen. Joshua K. Sabari served on an advisory board for AstraZeneca, Genentech, Johnson & Johnson, Pfizer, Regeneron, Sanofi, Takeda, and Mirati Therapeutics. Catherine A. Shu served on an advisory board for AstraZeneca, Genentech, Gilead, and Johnson & Johnson. Nicolas Girard received consulting fees from AbbVie, Amgen, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Gilead, Roche, Johnson & Johnson, LEO Pharma, Eli Lilly, Merck Sharp & Dohme, Novartis, Sivan Innovation, Mirati Therapeutics, Pfizer, Sanofi, and Takeda; received honoraria from AbbVie, Amgen, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Gilead, Roche, Johnson & Johnson, LEO Pharma, Eli Lilly, Merck Sharp & Dohme, Novartis, Sivan Innovation, Mirati Therapeutics, Pfizer, Sanofi, and Takeda; received support for meetings/travel from Janssen, Amgen, and Bristol Myers Squibb; and served in an advisory role for Roche. Aaron S. Mansfield received grants or contracts from Novartis and Verily; received consulting fees from Rising Tide and Triptych Health; received honoraria from Johnson & Johnson, BeiGene, Chugai Pharmaceutical Co., IDEOlogy Health, Antoni van Leeuwenhoek Kanker Instituut, AXIS Medical Education, Johnson & Johnson, Intellisphere, Answers in CME, Miami International Mesothelioma Symposium, and Immunocore; received support for meetings/travel from Roche; served in an advisory role for AbbVie, AstraZeneca, Bristol Myers Squibb, Genentech/Roche, and Takeda; served in a leadership role for Mesothelioma Applied Research Foundation and Friends of Patan Hospital; and has other relationships with Bristol Myers Squibb. Keunchil Park served in an advisory role for AstraZeneca, Eli Lilly, Ono Pharmaceutical, Bristol Myers Squibb, Merck Sharp & Dohme, Blueprint Medicines, Amgen, Merck, Loxo Oncology, AbbVie, Daiichi Sankyo, Boehringer Ingelheim, Johnson & Johnson, Eisai, and Puma Biotechnology; served on a speakers bureau for Boehringer Ingelheim; and received research funding from AstraZeneca and Merck Sharp & Dohme. Yichuan Xia is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Archan Bhattacharya is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Nasuh Buyukkaramikli is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Nolen Perualila is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Joris Diels is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Sandip Acharya is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Conor Chandler is an employee of Evidera and Evidera received payment from Johnson & Johnson for the conduct of this study. Irina Proskorovsky is an employee of Evidera and Evidera received payment from Johnson & Johnson for the conduct of this study. Lindsay Dearden is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Honeylet Wortman-Vayn is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Parthiv J. Mahadevia is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Roland E. Knoblauch is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Trishala Agrawal is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Mahadi Baig is an employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Enriqueta Felip served in a consulting or advisory role for AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Roche, Gilead, GSK, Johnson & Johnson, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Pfizer, Regeneron, Sanofi, Takeda, Turning Point Therapeutics, and Daiichi Sankyo; served on a speakers bureau for Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Roche, Genentech, Johnson & Johnson, Medical Trends, Medscape, Merck Serono, Merck Sharp & Dohme, PeerVoice, Pfizer, Sanofi, Takeda, and TouchONCOLOGY; received travel, accommodations, or expenses from AstraZeneca, Johnson & Johnson, and Roche; and has other relationships with Grifols, Hospital Universitari Parc Tauli, Sociedad Española de Oncología Médica, and ETOP IBCSG Partners Foundation.

: The trial was conducted in accordance with the provisions of the Declaration of Helsinki, Good Clinical Practice guidelines (as defined by the International Council for Harmonisation), applicable regulatory requirements, and the policy on bioethics and human biologic samples of the trial sponsor, Janssen Research and Development. The study protocols, amendments, and relevant documents were approved by the local independent ethics committee or institutional review board at each study site.

: All patients provided written informed consent prior to treatment.

: Not applicable.

: The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at . As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at .

: Not applicable.

: Study concept and design: RES, YX, AB, NB, NP, JD, SA, CC, LD, HWV, PJM, REK, EF. Data acquisition: RES, CZ, KJT, BCC, SC, SP, AO, SL, MM, AA, MDRGC, HH, KYL, SHL, AD, JAA, GR, VS, CD, JKS, CAS, NG, ASM, KP, TA, MB, EF. Data analysis: YX, AB, NB, NP, JD, SA, CC, IP, LD, HWV, PJM, REK. Data interpretation: all authors. Drafting or critically revising manuscript: all authors. Approval of final version: all authors.