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Article History

Received: 8 September 2022

Accepted: 9 August 2023

First Online: 26 September 2023

Declarations

:

: The study protocol was approved by the Ethics Committee of the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (INT 240/19, v.1.1 21/10/2019) and by local Committees of participating Centers. The trial has been registered in EudraCT database (2019–004506-10) and at clinicaltrials.gov (NCT04427787). This study will be conducted in full conformance with the ICH E6/GCP guidelines and the principles of the Declaration of Helsinki. All study participants will provide their voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Any protocol amendments will be prepared by the Sponsor and submitted to the IRB/EC and to regulatory authorities in accordance with local regulatory requirements. If an amendment substantially alters the study design or increases the potential risk to the participant, patients will be re-consented to the most current version of the Consent Forms or to a significant addendum in accordance to IRB/IEC policy and applicable laws. The Sponsor maintains confidentiality standards by coding each patient through assignment of a unique patient identification number. Each participating Investigator is responsible for ensuring data quality. 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. The Sponsor provides an insurance policy in case patients suffer harm from trial participation.

: Not applicable.

: Dr. Pusceddu reported receiving honoraria from Novartis, Ipsen, Pfizer, Merck Serono, and Advanced Accelerator Applications (AAA); receiving grants from Ipsen and Pfizer; and receiving personal fees from AAA, Novartis, and Merck outside the submitted work. Dr. Prinzi reported receiving honoraria and travel accommodations from Novartis, Ipsen, Pfizer, Merck Serono, and Italfarmaco and receiving personal fees from Merck outside the submitted work. Dr. Panzuto reported receiving honoraria for speaker and advisory roles from Novartis, for an advisory role from Ipsen, and for consulting from AAA and receiving travel accommodations from Pfizer. Dr. Corti reported receiving nonfinancial support from AAA and Ipsen outside the submitted work. Dr. Porcu reported receiving honoraria for consulting from Ipsen and Italfarmaco. Dr. de Braud reported receiving honoraria for serving on advisory boards or speakers bureaus for Amgen, Novartis, Roche, Incyte, EMD Serono, Bristol Myers Squibb, Roche, Pfizer, Menarini, Sanofi, Healthcare Research & Pharmacoepidemiology, and Dephaforum; receiving research funding from Novartis, Roche, Merck Sharp & Dohme, Merck Serono, Pfizer, Servier, and Nerviano Medical Sciences; and receiving honoraria and/or personal fees from Roche, EMD Serono, Nerviano Medical Sciences, Sanofi, MSD, Novartis, Incyte, Bristol Myers Squibb, Menarini, Merck, Pfizer, Healthcare Research & Pharmacoloepidemiology, Servier, Amgen, and Dephaforum outside the submitted work. No other disclosures were reported.