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Article History

Received: 6 December 2024

Accepted: 26 September 2025

First Online: 12 November 2025

Declarations

:

: This study is conducted in agreement with either the Declaration of Helsinki or the laws and regulations of the country, whichever provides the greatest protection for the patient. The protocol has been written, and the study is conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice. The study (Protocol version 1.0, February 22, 2022) was approved for all participating centers by AIFA, the Italian health authority (Agenzia Italiana del Farmaco) on December 1 st, 2023, and registered at Clinicaltrials.gov (NCT06464068) on June 16, 2024. IEC(s)/IRB(s) approved the submitted documents for each center. Company QBE Insurance was appointed by GOIRC for an insurance policy to reimburse patients for any injury associated with the study. Changes to eligibility criteria, outcomes, analysis, or other important protocol modifications will be notified to the IEC/IRB for approval and will be forwarded to the Sponsor. Informed consent to study procedures before enrollment in the study was signed by all candidates. Moreover, those will be informed about the study purpose, the activities involved, the expected duration, and the potential risks and benefits by the investigators (or legally authorized representatives).

: Not applicable.

: A.D.: outside the submitted work, has received personal fees for the advisory role, speaker engagements, and travel and accommodation expenses from Ipsen, Servier, BMS, Merck Serono, Amgen, and Daichii Sankyo.C.P.: outside the submitted work personal fees for the advisory role, speaker engagements, and travel and accommodation expenses from Amgen, Astellas, AstraZeneca, Bayer, Bristol Meyer Squibb, Celgene, Daiichi Sankyo, Eisai, Ipsen, Janssen, Incyte, Merck-Serono, Merck Sharp and Dohme, Novartis, Roche, Sandoz, Sanofi, and Servier.N.B.: outside the submitted work, has received travel support from Ipsen, Novartis, Janssen-Cilag, Pfizer, Advanced Accelerator Applications, and speaker honoraria from Bristol-Myers Squibb, Gentili Oncology, and Johnson & Johnson.F.G.: outside the submitted work, has received honoraria for Advisory board/Speaker’s bureau from Servier, Eli Lilly, Bristol-Myers Squibb, Iqvia, Merck Serono, Amgen, Pierre-Fabre.F.S.: outside the submitted work, has received honoraria for Writing Engagement/invited speaker/educational activities from Ipsen, Merck, SAS SPA, and Novartis.E.M.: Receipt of honoraria or consultation fees for speaker, consultancy, or advisory roles from Amgen, Bayer, Eisai, Merck Serono, Pierre Fabre, Roche, Servier, Incyte, ESMO, MSD. Travel grant: AstraZeneca, Pierre Fabre.