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Article History

Received: 24 September 2018

Accepted: 20 March 2019

First Online: 29 March 2019

Ethics approval and consent to participate

: The study was registered on April 202,016 at EudraCT database (2016–001783-12) and on October 172,016 at ExternalRef removed (NCT02934464) and it is currently ongoing.The trial was approved by the Ethics Committee of the Fondazione IRCCS Istituto Nazionale Tumori di Milano and by local Committees of participating centers. 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.All study participants will provide their written informed consent after careful explanation by their treating investigators. Sponsor’s sample Informed Consent Form will be provided to each site. Each Site can modify the template provided, but the Sponsor will review and approve any proposed deviations from the sample Informed Consent Forms or any alternate consent forms proposed by the site (collectively, the “Consent Forms”) before IRB/EC submission. Regarding specific Informed Consent(s) on exploratory biomarkers, 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.

: MDB: advisor role/speaker bureau for Eli Lilly, Servier; FP: advisory role/ speaker bureau for Amgen Inc., Roche, Sanofi, Eli Lilly and Bayer Healthcare; SL: advisory role/speaker burearu for Amgen Inc., Bayer Helthcare, Merk and Eli Lilly, research funding from Amgen Inc. and Merk Serono; ST: advisor role for Eli Lilly, LR: advisory role/ speaker bureau for AstraZeneca,Abbvie, Lilly, Bayer, Sirtex Medical, Italfarmaco, Sanofi, ArQule, Baxter, Ipsen, Exelixis, Amgen, Incyte, Celgene. For the other authors there no competing interests for this study.

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