Funding

Open access publishing supported by the National Technical Library in Prague.

Conflicts of Interest/Competing Interests

Ondrej Fiala received honoraria from Novartis, Janssen, Merck, BMS, MSD, Pierre Fabre, and Pfizer for consultations and lectures unrelated to this project. Sebastiano Buti has received honoraria for speaking at scientific events and advisory roles from AstraZeneca, BMS, Ipsen, Merck, Eisai, MSD, Novartis, and Pfizer and research funding from Novartis and Pfizer unrelated to this project. Francesco Massari has received research support and/or honoraria from Astellas, BMS, Janssen, Ipsen, MSD, and Pfizer outside the submitted work. Enrique Grande has received honoraria for speaker engagements, advisory roles, or funding of continuous medical education from Adacap, Amgen, Angelini, Astellas, AstraZeneca, Bayer, Blueprint, Bristol Myers Squibb, Caris Life Sciences, Celgene, Clovis-Oncology, Eisai, Eusa Pharma, Genetracer, Guardant Health, HRA-Pharma, Ipsen, ITM-Radiopharma, Janssen, Lexicon, Lilly, Merck KGaA, MSD, Nanostring Technologies, Natera, Novartis, ONCODNA (Biosequence), Palex, Pharmamar, Pierre Fabre, Pfizer, Roche, Sanofi-Genzyme, Servier, Taiho, and Thermo Fisher Scientific and research grants from Pfizer, AstraZeneca, Astellas, and Lexicon Pharmaceuticals. All of the above are unrelated to the present paper. Ugo De Giorgi services as an advisory/board member of Astellas, Bayer, BMS, Ipsen, Janssen, Merck, Pfizer, and Sanofi, has received research grant/funding to the institution from AstraZeneca, Roche, and Sanofi, and travel/accommodations/expenses from AstraZeneca, BMS, Ipsen, Janssen, and Pfizer. All of the above are unrelated to the present paper. Javier Molina-Cerrillo declares consultant, advisory, or speaker roles for Ipsen, Roche, Pfizer, Sanofi, Janssen, and BMS unrelated to this project. Zin W. Myint has received research support from Merck unrelated to the present paper. Ray Manneh Kopp has received research support and/or honoraria from Amgen, Astellas, AstraZeneca, Bayer, BMS, Eli Lilly, Janssen, MSD, Pfizer, Tecnofarma, and Roche unrelated to this project. Jakub Kucharz has received honoraria from Angelini, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, IPSEN, Janssen, Merck MSD, Novartis, and Pfizer, and research funding from Novartis, all unrelated to the present paper. Maria Giuseppa Vitale has received honoraria from Astellas, BMS, MSD, and Ipsen unrelated to this project. Alvaro Pinto has received research support and/or honoraria from Pfizer, Novartis, Ipsen, BMS, Janssen, Astellas, Sanofi, Bayer, Clovis, Roche, MSD, Pierre Fabre, Merck, Bayer, Pharmacyclics, AstraZeneca, Eisai, and Aveo unrelated to this project. Thomas Büttner has received fees for speakers bureau, travel, and accommodation from Astellas, Ipsen, and MSD, all unrelated to the present paper. Carlo Messina has received fees for speakers bureau and advisory board activities from Merck, MSD, BMS, Eisai, Ipsen, Johnson and Johnson, Astellas, AstraZeneca, Baier, and GSK, all unrelated to the present paper. Fernando Sabino M. Monteiro has received research support from Janssen and Merck Sharp Dome and honoraria from Janssen, Ipsen, Bristol Myers Squibb, and Merck Sharp Dome. All unrelated to the present paper. Ravindran Kanesvaran has received fees for speakers bureau and advisory board activities from Pfizer, MSD, BMS, Eisai, Ipsen, Johnson and Johnson, Merck, Amgen, Astellas, and Bayer, all unrelated to this project. Tomáš Büchler has received research support from AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Merck KGaA, MSD, and Novartis, consulting fees from Bristol Myers Squibb, Astellas, Janssen, and Sanofi/Aventis, payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol Myers Squibb, AstraZeneca, Roche, Servier, Accord, MSD, and Pfizer. All of the above are unrelated to the present paper. Jindřich Kopecký has received consulting fees from Bristol Myers Squibb, Novartis, Pfizer, Merck, MSD, and Ipsen and payment or honoraria for lectures, presentations, speakers bureau, manuscript writing, or educational events from Ipsen, Bristol Myers Squibb, MSD, Merck, Novartis, and Pfizer. All of the above are unrelated to the present paper. Camillo Porta has received honoraria from Angelini Pharma, AstraZeneca, BMS, Eisai, Ipsen, and MSD and acted as a Protocol Steering Committee Member for BMS, Eisai, and MSD unrelated to this project. Matteo Santoni has received research support and honoraria from Janssen, Bristol Myers Squibb, Ipsen, MSD, Astellas, A.A.A., and Bayer unrelated to the present paper. Aristotelis Bamias, Renate Pichler, Marco Maruzzo, Emmanuel Seront, Fabio Calabrò, Gaetano Facchini, Rossana Berardi, Luigi Formisano, Nicola Battelli, Daniele Santini, and Giulia Claire Giudice have no conflicts of interest that are directly relevant to the content of this article.

Ethics Approval

The study protocol was approved by the ethical committee of the coordinating center (Marche Region—2021-492, Study Protocol “ARON-1 Project” NCT05287464) and by the institutional review boards of the international participating centers.

Consent to Participate

Not applicable.

Consent for Publication

Not applicable.

Availability of Data and Material

The datasets generated and/or analyzed during the current study are not publicly available because of patient data security but are available from the corresponding author on reasonable request.

Code Availability

Not applicable.

Authors’ Contributions

Study concept and design: all authors. Acquisition of data: all authors. Analysis and interpretation of data: all authors. Drafting of the manuscript: OF, SB, MS, CG. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: MS. Obtaining funding: none. Administrative, technical, or material support: none. Supervision: CP.