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To our knowledge, I\n                    <jats:sup>3<\/jats:sup>\n                    LUNG (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\/study\/NCT05537922\" ext-link-type=\"uri\">NCT05537922<\/jats:ext-link>\n                    ) is currently the largest international, real-world, multimodal, artificial intelligence (AI)-based study, enrolling 2,396 patients. We integrated real-world clinical and blood (CB) data, computed tomography (CT) images, digital pathology (DP), and genomics into machine learning early fusion (MLEF) and deep learning intermediate fusion (DLIF) models. Machine learning (ML) and deep learning (DL) CB-only models achieved consistent performance across outcomes with area under the curve (AUC) up to 0.77 in the test (TEST) set. Performance drop in external validation (EXVAL) likely reflects population differences (AUC range: 0.55\u20130.72). AI models significantly surpassed PD-L1, Eastern Cooperative Oncology Group performance status (ECOG PS), neutrophil-to-lymphocyte ratio (NLR), lactate dehydrogenase (LDH) and Lung Immune Prognostic Index (LIPI) score in the independent TEST set. The clinical usability study showed that lung expert and nonexpert physicians improved their prediction with the explainable AI (XAI) ML CB-only based tool. Although multimodal integration with MLEF (CB+CT+DP) was associated with higher performance, its incremental benefit remains uncertain, not translated in TEST and EXVAL. The I\n                    <jats:sup>3<\/jats:sup>\n                    LUNG project is a pioneering framework showing the clinical usefulness of AI tools. 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Hoffmann-La Roche, Regeneron and Takeda (invited speaker); Amgen, AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, MEDSIR, Merck Sharp & Dohme, Pfizer and Summit Therapeutics (advisory board); Bristol Myers Squibb, Bayer, AstraZeneca, Merck Sharp & Dohme, Eli Lilly, Nuvalent, Spectrum, Roche and AstraZeneca (local PI, institutional); Italfarmaco and AstraZeneca (training of personnel); Johnson & Johnson and Roche (travel grants); European Interdisciplinary Society of AI in Cancer Research (ESAC) (leadership role, President); and I\n                      3\n                      LUNG (Project Lead). V.M.: Novartis, Daiichi Sankyo, Merck, Events S.r.l., Accademia Nazionale di Medicina and Events S.r.l. Congress & Communication (invited speaker) and ESAC. A.F.: Novartis and Merck (invited facilitator to AI workshop). C.M.L.: Novartis (invited facilitator to AI workshop). L.P.: Novartis, Merck and Pfizer (invited speaker). M.F.: Novartis (invited facilitator to AI workshop). A.Z.: Novartis (invited facilitator to AI workshop). A.S.: Novartis, Merck Sharp & Dohme, Bristol Myers Squibb, Pierre Fabre and Immunocore (educational speaker). C. Silvestri: Novartis (invited facilitator to AI workshop). L.I.: Merck (invited facilitator to AI workshop). L.M.: Sanofi, Daiichi Sankyo and LEO Pharma (conference grants); Novartis, Merck, Elma Research, Edge Consulting and Johnson & Johnson (honoraria); and Boehringer Ingelheim (local PI, institutional). G.C.: Amgen, AstraZeneca, Pfizer, Johnson & Johnson, Bristol Myers Squibb, Boehringer Ingelheim, Istituti Gentili, F. Hoffmann-La Roche and Merck Sharp & Dohme (travel grants) and Takeda, Johnson & Johnson and AstraZeneca (honoraria and consultancy). C.M.B.: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Catalyst, Daiichi Sankyo, EMD Serono, Exelixis, Genentech, Jazz Pharmaceuticals, Johnson & Johnson, Eli Lilly, Merck Sharp & Dohme, Mirati Therapeutics, Novartis, Pfizer, Summit Therapeutics and Turning Point Therapeutics (advisory board, personal); Voronoi and AstraZeneca (coordinating PI, institutional, financial interest, steering committee member, personal); and Bristol Myers Squibb (other, institutional, financial interest, subinvestigator on Bristol Myers Squibb-funded investigator-initiated trial). E.S.: Amgen (advisory board, invited speaker); Bristol Myers Squibb (advisory board, invited speaker); Johnson & Johnson (advisory board, invited speaker); Merck Sharp & Dohme (advisory board, invited speaker); F. Hoffmann-La Roche (advisory board, invited speaker); AstraZeneca (invited speaker); Genesis Pharma (invited speaker); Novartis (invited speaker); and Daiichi Sankyo. E. Fountzilas: Amgen and Daiichi Sankyo (advisory role); AstraZeneca, Genesis Pharma, Daiichi Sankyo and KAM (travel grants); Genesis Pharma, Eli Lilly, GlaxoSmithKline and AstraZeneca (speaker); and Genprex and Deciphera Pharmaceuticals (stock ownership). P.I.: Amgen, AstraZeneca, Bristol Myers Squibb, F. Hoffmann-La Roche, Johnson & Johnson, PeerVoice, Pfizer and Regeneron (invited speaker, personal); Boehringer Ingelheim (honoraria and\/or consulting fees); and Merck Sharp & Dohme, AstraZeneca, Johnson & Johnson and F. Hoffmann-La Roche (support for meeting attendance and\/or travel). M.F.-P. and J.R.-M. are full-time employees of MEDSIR. E.R.: AstraZeneca (institutional, research grant); Gilead Sciences (institutional, research grant); Merck Sharp & Dohme (institutional, research grant); F. Hoffmann-La Roche (institutional, research grant); GlaxoSmithKline (institutional, research grant); Philogen (personal, independent data monitoring committee participation). M.P.D.P.: AstraZeneca (institutional, research grant); Gilead Sciences (institutional, research grant); Merck Sharp & Dohme (institutional, research grant); F. Hoffmann-La Roche (institutional, research grant); and GlaxoSmithKline (institutional, research grant). M.O.: AstraZeneca, Bristol Myers Squibb and Merck Sharp & Dohme (honoraria); AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer and Johnson & Johnson (advisory role or consultancy); and Eli Lilly and Johnson & Johnson (travel, accommodations, expenses). M.B.: Johnson & Johnson and LEO Pharma (travel, accommodations, grants) and Bristol Myers Squibb and AstraZeneca (honoraria). T.B.: Merck Sharp & Dohme, Sanofi, Pfizer, Bristol Myers Squibb and Eli Lilly (travel, accommodations, grants) and Merck Sharp & Dohme and Johnson & Johnson (honoraria). M.W.: Full-time employee, minority owner and member of the Board of Directors at the Swedish Institute of Health Economics. C.P.: AstraZeneca, F. Hoffmann-La Roche, Merck Sharp & Dohme, Bristol Myers Squibb, Johnson & Johnson and Regeneron (honoraria); Daiichii Sankyo, AstraZeneca, F. Hoffmann-La Roche, Merck Sharp & Dohme, Johnson & Johnson, Sanofi, Takeda, Pfizer, Bristol Myers Squibb, Regeneron, La Roche Posay and Pierre Fabre (advisory board, travel accommodations); and Johnson & Johnson, Pfizer, Eli Lilly, Spectrum Pharmaceuticals, Amgen, Bristol Myers Squibb, AstraZeneca, Merck Serono and Merck Sharp & Dohme (local PI). G. Pravettoni: Eli Lilly, AstraZeneca, Menarini Stemline, Illumina, F. Hoffmann-La Roche and ADS Biotec (honoraria, travel, advisory board). G. Pruneri: Roche, Menarini, Incyte, Johnson & Johnson and AstraZeneca (honoraria), and Novartis (research grant). F.D.B.: Mattioli 1885, McCann Health, Merck Sharp & Dohme, IQVIA, Novartis, Indena, Incyte, Taiho, Menarini and F. Hoffmann-La Roche (consulting); Sanofi, Bristol Myers Squibb, Taiho, Incyte, AstraZeneca, Merck Sharp & Dohme and F. Hoffmann-La Roche (advisory); AnHeart Therapeutics, Apollomics, AstraZeneca, Basilea Pharmaceutica, Bayer Healthcare, Boehringer Ingelheim, Bristol Myers Squibb, F. Hoffmann-La Roche, Incyte, Itanet, Janssen-Cilag, Kymab, Loxo Oncology, MedImmune, Merck KGaA, Novartis and Tesaro (local PI); Nadirex, European School of Oncology, Motore Sanit\u00e0, Effeti, Events S.r.l., Bristol Myers Squibb, ACCMED, Idea-z, Dynamicom Education, Sanofi and AstraZeneca (speaker fees); Incyte, Bristol Myers Squibb, Novartis, Sanofi and AstraZeneca (speaker bureau); Incyte, Bristol Myers Squibb, Novartis, Sanofi and AstraZeneca (travel expenses); and F. Hoffmann-La Roche (other interests). E. Felip: AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, e-Cancer, Eli Lilly, Ellipses Pharma, Genentech\/F. Hoffmann-La Roche, Gilead Sciences, GlaxoSmithKline, ITEOS Therapeutics, Johnson & Johnson, Medical Trends, Medscape, Merck Sharp & Dohme, PeerVoice, Physicians\u02bc Education Resource, Pfizer, PharmaMar, Pierre Fabre, Regeneron, Seagen and Tubulis (advisory board\/invited speaker); Grifols (independent board member); and AstraZeneca, Johnson & Johnson, Pfizer and F. Hoffmann-La Roche (support for meeting attendance and\/or travel). N.P.: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Imagine, Guardant, Imagene, Merck, Merck Sharp & Dohme, Novartis, Pfizer, F. Hoffmann-La Roche, Renium and Takeda (advisory, honoraria, research). A.T.P.: Thermo Fisher Scientific, Breakthrough Cancer and Daiichi Sankyo (advisory board); AbbVie, IBM and Thermo Fisher Scientific (research funding); and Caris (travel). H.L.: AstraZeneca, Merck Sharp & Dohme and Pierre Fabre (honoraria as invited speaker); Vianex and Merck Sharp & Dohme (support for attending scientific meetings); AstraZeneca, Merck Sharp & Dohme, Pfizer and Sandoz (advisory board); and AstraZeneca, AbbVie, Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, F. Hoffmann-La Roche, PPD, Parexel, PRA, Qualitis and Perseus Healthcare Group S.A. (personal and institutional fees for clinical trials). M. Reck: Amgen, AstraZeneca, BeOne Medicines, BioNTech, Boehringer Ingelheim, Daiichi Sankyo, GSK, Eli Lilly, Mirati Therapeutics, Merck, MSD, Novartis, Pfizer, Regeneron, Roche, Sanofi, Samsung Bioepis and Takeda (honoraria for lectures and consultancy); Amgen, AstraZeneca, BeOne Medicines, BMS, Daiichi Sankyo, Mirati Therapeutics, Merck, MSD, Novartis, Pfizer, Roche and Takeda (compensated membership in study steering committees); and Servier and Sanofi (compensated membership in data safety monitoring committees). G.L.R.: Merck Sharp & Dohme, Regeneron, F. Hoffmann-La Roche, Eli Lilly, Bristol Myers Squibb, Amgen, AstraZeneca, Johnson & Johnson, Merck Seronos, Novartis, Pierre Fabre, Bayer, BeOne Medicines, Pfizer, Takeda, GlaxoSmithKline, Daiichi Sankyo, Sanofi, Gilead Sciences, Novocure, Revolution Medicines, Summit Therapeutics and Immutep (advisory boards, consultancies, travel accommodations, speaker fees, writing fees, PI role in profit trials). F.T.: ML cube S.r.l. (co-founder), Accademia Nazionale di Medicina, Over S.r.l., Events S.r.l. Congress & Communication, PREX S.r.l. and Cefriel S.c.a.r.l. (honoraria). A.L.G.P.: Agade S.r.l. and AllyArm S.r.l., Novartis, ACCMED, Pfizer, Fondazione Cariplo, Fondazione Telethon, Fondazione Valduce, Fondazione FORST, Kayser Italia S.r.l., Generali Wellion, Tecnobody S.r.l., EMAC S.r.l., Merz Therapeutics, AllyArm S.r.l., Viktor S.r.l., and FASI. M.C.G.: AbbVie, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead Sciences, IO Biotech, Johnson & Johnson, Merck Sharp & Dohme, Mirati Therapeutics, Natera, Novocure, Nuvation, Nuvalent, Pfizer, Regeneron, Revolution Medicines, F. Hoffmann-La Roche, Summit Therapeutics and Takeda (personal financial interest) and Aptitude Health, the American Society for Radiation Oncology, Ideology, Intellisphere, MJH Life Sciences, OncoHost and the International Association for the Study of Lung Cancer (non-pharma personal financial interests). M. Ruggirello: AstraZeneca (honoraria). L.A.: Roche (consultancy). The other authors declare no competing interests.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Ethics"}}]}}