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Article History

Received: 23 September 2024

Accepted: 1 April 2025

First Online: 8 April 2025

Declarations

:

: The study was registered on 02/02/2024 at Clinicaltrials.gov (NCT06253650) and it is currently ongoing.The trial was submitted to CTIS and approved by the Ethics Committee “CET Comitato Etico Lombardia 4”.The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable regulatory requirements and the Company policy on Bioethics and Human Biological Samples.The Informed Consent Form will incorporate (or, in some cases, be accompanied by a separate document incorporating) wording that complies with relevant data protection and privacy legislation.The names of patients will not be recorded; a sequential identification number will be attributed to each patient registered in the trial. This number will identify the patient and must be included on all eCRF. To avoid identification errors, patients’ initials (maximum of 2 letters) and date of birth will also be reported on the eCRF. Investigators will guarantee that all persons involved in this study will respect the confidentiality of any information concerning the trial subject. All parties involved in this clinical trial will maintain strict confidentiality to assure that neither the person nor the family privacy of the patient participating in the trial is violated. Appropriate measures shall be taken to avoid the access of non-authorized persons to the trial data by assuring that only the principal investigator and its delegates will have the authorization to access trial data thanks to protected programs and strict organization flows. The investigator will guarantee to have a process in place to ensure that the site staff or service providers delegated by the investigator/institution can identify the occurrence of a (potential) serious breach and this will be promptly reported.The processing of the personal data of patients taking part in the trial, and regarding data concerning consent, shall comply with local law on the privacy (D.Lg. 30 giugno 2003, n. 196, Codice in materia di protezione dei dati personali) and with the European Directive on the privacy of data, namely General Data Protection Regulation, EU regulation 2016/679 of 27 April 2016). The patient can withdraw consent whenever he/she wants and further data will not be collected, even if the already collected data will be used for the study’s analyses.

: Not applicable.

: FB received personal honoraria as invited speaker from Eli-Lilly, MSD, EISAI, Bristol Myers Squibb, AstraZeneca, Pierre Fabre; participation in advisory board for Servier, AAA Novartis. LF reports personal honoraria as invited speaker from Incyte, Bristol Myers Squibb, Lilly, AstraZeneca; 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, BeiGene and Astellas. AP reports personal fees for advisory boards from Takeda, GlaxoSmithKline, Daiichi Sankyo; research grant (institutional) from Amgen and GlaxoSmithKline. Travel grants from Amgen, Merck Serono, Astrazeneca FP 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. AR reports honoraria for speaker bureau or participation at advisory boards from Servier and MSD.LF reports personal honoraria as invited speaker from Incyte, Bristol Myers Squibb, Lilly, AstraZeneca; 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, BeiGene and Astellas.AP reports personal fees for advisory boards from Takeda, GlaxoSmithKline, Daiichi Sankyo; research grant (institutional) from Amgen and GlaxoSmithKline. Travel grants from Amgen, Merck Serono, Astrazeneca.FP 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.AR reports honoraria for speaker bureau or participation at advisory boards from Servier and MSD.