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Article History

Received: 10 January 2023

Accepted: 16 August 2023

First Online: 31 August 2023

Declarations

:

: All patients provided written informed consent. This trial was conducted in accordance with the Good Clinical Practice guidelines and Declaration of Helsinki. An independent ethics committee or institutional review board at each site approved the study protocol and any modifications. The study conduct was supervised by a steering committee comprising participating investigators and Novartis representatives. The safety data were assessed by an independent data monitoring committee.

: All named authors have contributed to the manuscript and agreed to its submission.

: PN has nothing to disclose. PAF reports personal fees for advisory boards and invited speaker fees from Novartis, Pfizer, Daiichi Sankyo, AstraZeneca, Eisai, Merck Sharp & Dohme, Lilly, Seagen, Roche, and Gilead; institutional funding from BioNTech and Cepheid; research grant from Pfizer; and personal fees for advisory boards from Pierre Fabre, Hexal, Agendia, and Sanofi Aventis. SC reports personal fees for advisory boards and institutional grants for participation in clinical trials from Novartis, Pfizer, Hoffmann-LaRoche, and Eli Lilly during the conduct of the study and outside the submitted work. GJ reports personal fees and nonfinancial support from Novartis during the conduct of the study; personal fees and nonfinancial support from Novartis, Roche, Pfizer, Lilly, Amgen, BMS, AstraZeneca, AbbVie, Daiichi Sankyo, and Seagen outside the submitted work; and nonfinancial support from MedImmune and Merck KGaA outside the submitted work. MDL reports personal fees for speaker honoraria and advisory board honoraria from Pfizer, Novartis, Roche, AstraZeneca, Eisai, Eli Lilly, and Pierre Fabre outside the submitted work and personal fees for advisory board honoraria from MSD outside the submitted work. S-AI reports research grants from AstraZeneca, Eisai, Daewoong, Pfizer, and Roche; personal fees and nonfinancial support for presenting results of clinical trial from Novartis; and personal fees from AstraZeneca, Hanmi, Pfizer, Eisai, Amgen, GSK, MSD, Roche, and Lilly outside the submitted work. KP reports personal fees for advisory boards from Novartis, AstraZeneca, Roche, and Pfizer outside the submitted work. GVB reports personal fees for advisory boards from Roche, Novartis, Eli Lilly, Seagen, AstraZeneca, Daiichi Sankyo, and MSD outside the submitted work. MM reports personal fees for speaker honoraria and honoraria for participation in advisory boards from Lilly and Pfizer; honoraria for participation in advisory boards from AstraZeneca, GlaxoSmithKline, PharmaMar, and Taiho Oncology; and research grants and honoraria for participation in advisory boards from Novartis and Roche/Genentech outside the submitted work. AN reports personal fees for consulting/advisory roles and travel/accommodation/expenses and research funding from Novartis and personal fees for consulting/advisory role from Amgen during the conduct of the study. GSS reports institutional reimbursement for patient accrual during the conduct of the study; institutional reimbursement for education and steering committee activities from Novartis; and institutional research support from Merck, AstraZeneca, Roche, and Seagen outside the submitted work. LDlCM reports personal fees from BMS, MSD/Merck, Roche, and Gilead outside the submitted work. JTB reports grants for institutional funding for doing research from AbbVie, Alliance, Argenx, Ascentage Pharma Group, AstraZeneca, Biodesix, Bio-Thera, Bristol Myers Squibb, Celgene, Eli Lilly, Genentech/Roche, Hutchison, Immunomedics, Gilead, MT Group, Merck, Nektar, Pfizer, Polynoma, Seagen, Serono/EMD, Tesaro, TG Therapeutics, Daiichi Sankyo, Exact Sciences, Boehringer Ingelheim, Laekna, Novocure, Mirati Therapeutics, Tarveda Therapeutics, Sumitomo Dainippon Pharma Oncology, Elpiscience Biopharma, Takeda, Vaccinex, Vincerx Pharma, Ultimovacs, and Mersana during the conduct of the study. JPZ, YW, AC, and CW report employment with and stock ownership of Novartis. DS reports board of directors (stock) and travel expenses from BioMarin; stock ownership, research funding, and travel expenses from Pfizer; advisory board, consulting, research funding, and travel expenses from Novartis; consulting fees from Eli Lilly; and stock ownership of Amgen and Seattle Genetics outside the submitted work.