Updates are available Correction dated 2024-05-06

Article History

Received: 19 December 2023

Accepted: 2 April 2024

First Online: 8 April 2024

Change Date: 6 May 2024

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1186/s12885-024-12328-0

Declarations

:

: The study was registered on 16/03/2023 at EuCT database (2023-503295-25-00) and on 07 Sep 2023 at Clinicaltrials.gov (NCT06037980) and it is currently ongoing.The trial was submitted to CTIS and approved by the Ethics Committee “CET Comitato Etico Regione Toscana – Area Vasta Sud Est”.All study participants will provide their written informed consent after careful explanation by their treating investigators.This study will be conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki. The study will comply with the requirements of the ICH E2A guideline.Sponsor’s sample Informed Consent Form will be provided to each site. Regarding exploratory analyses, the investigator or authorized designee will explain to each patient the objectives of the exploratory research. Patients will be told that they are free to refuse to participate and may withdraw their specimens at any time and for any reason. All relevant changes to study procedures or new information will be communicated to all relevant parties (investigators, IRBs, trial participants, trial registries, journals, regulators) and patients will be re-consented to the most current version of the Consent Forms (or to a significant new information/findings addendum in accordance with applicable laws and IRB/EC policy).The Sponsor maintains confidentiality standards by coding each patient enrolled in the study through assignment of a unique patient identification number. This means that patient names are not included in any of the study data sets. Patient medical information obtained by this study is confidential and may only be disclosed to third parties as permitted by the Informed Consent Form (or separate authorization for use and disclosure of personal health information) signed by the patient, unless permitted or required by law. Data generated by this study must be available for inspection upon request by representatives of the national and local health authorities, Sponsor’s monitors, representatives, and collaborators, and the IRB/EC for each study site, as appropriate.

: Not applicable.

: MN: Travel expenses from AstraZeneca, speaker honorarium from Accademia della Medicina and Incyte; honoraria from Sandoz, Medpoint SRL, Incyte and Servier for editorial collaboration. Consultant honoraria from EMD Serono, Basilea Pharmaceutica, Incyte, MSD Italia, Servier, Astrazeneca and TaihoLR: reports consulting fees from AstraZeneca, Basilea, Bayer, BMS, Eisai, Elevar Therapeutics, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Jazz Pharmaceuticals, Lilly, MSD, Nerviano Medical Sciences, Roche, Servier, Taiho Oncology, Zymeworks; lecture fees from AstraZeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Merck Serono, Roche, Servier; travel expenses from AstraZeneca; research grants (to Institution) from Agios, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Zymeworks.LS: speakers’ and consultant's fee from MSD, Astra-Zeneca, Servier, Bayer, Merck, Amgen, Pierre-Fabre, Takeda, GSKFP: reports personal fees from Amgen, Merck-Serono, MSD, Bayer, Astellas, Takeda, Servier, GlaxoSmithKline, Pierre-Fabre, Ipsen, J&J; and research grant (institutional) from Lilly, BMS, AstraZeneca, Incyte, Amgen, and Agenus.LF: reports personal honoraria as invited speaker from Incyte, Bristol Myers Squibb, Lilly; research funding (to Institution) from MSD, Bristol Myers Squibb, AstraZeneca, Incyte, BeiGene, Astellas, Daiichi Sankyo, Roche; participation in advisory board for MSD, AstraZeneca, Incyte, Taiho, Servier, Daiichi Sankyo, Lilly, Astellas.RIG: advisory fee da MSD ItaliaLS: speakers’ and consultant's fee from MSD, Astra-Zeneca, Servier, Bayer, Merck, Amgen, Pierre-Fabre, Takeda, GSKRM: honoraria from BoeringerDM: Research Grants from Celgene, Evotec, Incyte, iOnctura, Roche, Servier, Shire; Consulting fees from Eli Lilly, Evotec, Incyte, iOnctura, IQVIA, Servier, Shire, Taiho; Honoraria for participation to Advisory Boards from Incyte, Roche, Servier, Taiho, Terumo; Payment for lectures or presentations from Baxter, Incyte, MSD Italia, Roche, ServierFdB: Consulting: BMS, Pierre Fabre, Mattioli 1885, MCCann Health, MSD, IQVIA, Novartis; Advisory arrangements: Tiziana Life Sciences, BMS, Celgene, Novartis, Servier, Pharm Research Associated, Daiichi Sankyo, Ignyta, Amgen, Pfizer, Octimet Oncology, Incyte, Pierre Fabre, Eli Lilly, Roche, AstraZeneca, Gentili, Dephaforum, Merck & Co., Kenilworth, NJ, Bayer, Fondazione Menarini, Sanofi, Incyte, Taiho; Speaker’s fees from BMS, Roche, Merck & Co., Kenilworth, NJ, Bayer, Ignyta, Dephaforum, Biotechespert, Prime Oncology, Pfizer, Nadirex, Ambrosetti, Incyte, Motore Sanità, Events, Fare Comunicazione, Itanet, Nadirex, ESO, AccMed, Idea-z; Grants/contracts: research, unrestricted, and/or travel: Novartis, Roche, BMS, Celgene, Incyte, NMS, the healthcare business of Merck KGaA, Darmstadt, Germany, Kymab, Pfizer, Tesaro, and Merck & Co., Kenilworth, NJ; Traveling expenses from Bristol Myers Squibb, Roche, Celgene, Amgen.All other authors declared no conflicts of interest.