Tokito, Takaaki http://orcid.org/0000-0002-8429-2287
Kolesnik, Oleksii
Sørensen, Jens
Artac, Mehmet
Quintela, Martín Lázaro
Lee, Jong-Seok
Hussein, Maen
Pless, Miklos
Paz-Ares, Luis
Leopold, Lance
Daniel, Jeannie
Munteanu, Mihaela
Samkari, Ayman
Xu, Lu
Butts, Charles
Funding for this research was provided by:
Incyte Corporation
Merck Sharp & Dohme, a subsidiary of Merck
Article History
Received: 19 August 2022
Accepted: 19 July 2023
First Online: 25 July 2024
Declarations
:
: Independent ethics committees, as defined by the US CFR Title 21, Part 56 or equivalent country-specific regulations, reviewed and approved the protocol and any amendments. This study was conducted to conform with the Declaration of Helsinki, Good Clinical Practice guidelines, applicable country and/or local statutes, regulations regarding independent ethics committee review, and the protection of human patients in biomedical research. The study was approved by the ethics committees at each institution (Akdeniz University Clinical Trials Ethics Committee; Austin Health Human Research Ethics Committee; Chungbuk National Univ. Hospital IRB; Clinical Research Ethics Committee—University College Cork; Comitato Etico Regione Liguria c/o IRCCS Ospedale Policlinico San Martino—Istituto di Ricovero e Cura a Carattere Scientifico per l’Oncologia; Comite Autonomico de Etica de la Investigacion de Galicia Calle San Lazaro sn Secretaria Xeral. Conselleria de Sanidade; Copernicus Group Independent Review Board; De Videnskabsetiske Komiteer For Region Hovedstaden; EC of Central Clinical Hospital with polyclinic of the Presidential Administration of the RF; Gachon University Gil Medical Center IRB/IEC; Health Research Ethics Board of Alberta; Helsinki Committee Chaim Sheba Medical Center; Horizon Health Network Ethics Committee; H.U. Vall de Hebron Passeig de la Vall d.Hebron sn; Joint Group Health Centre/Sault Area Hospital REB; Kanagawa Cancer Center Institutional Review Board; Kanazawa University Hospital Institutional Review Board; Kantonale Ethikkommission Zuerich; Kindai University Hospital Institutional Review Board; Komisja Bioetyczna przy Bydgoskiej Izbie Lekarskiej; Kurume University Institutional Review Board; Kyiv City Clinical Oncological Center; Kyushu University Hospital Institutional Review Board; LEC of Leningrad Regional Clinical Hospital; London Central Research Ethics Committee; Medical and Diagnostic Centre LLC Dobryi Prognoz IRB/IEC; Medical Research Ethics Committee Kompleks Pendidikan Sains Kejururawatan Tingkat 2 Pusat Perubatan Univ Malaya; Medical Ethics & Research Committee No.1 Jalan Setia Murni U13 52 Seksyen Block A Kompleks Institut Kesihatan Negara; MI Kryviy Rih Center of Dnipropetrovsk Regional Council IRB/IEC; MI Odessa Regional Oncological Centre; National Cancer Center Institutional Review Board; National Hospital Organization Nagoya Medical Center IRB; National Hospital Organization Shikoku Cancer Center IRB; Niigata Cancer Center Hospital Institutional Review Board; Okayama University Hospital Institutional Review Board; Ontario Cancer Research Ethics Board; Rabin Medical Center IRB-Committee; Rambam—MC – ERC; Segreteria tecnico-scientifica del Comitato Etico Fondazione Policlinico Universitario; Sendai Kousei Hospital Institutional Review Board; Seoul National University Bundang Hospital, Institutional Review Board; Shizuoka Cancer Center Hospital and Research Institute IRB; Soroka M.C IRB; St. John of God Health Care Human Research Ethics Committee IRB/IEC; US Oncology, Inc. IRB; Wakayama Medical University Institutional Review Board; Western IRB; WIRB-Copernicus Group WCG; and Zaporizhzhya Regional Clinical Oncology Center). All patients provided written informed consent before initiating treatment.
: Not applicable.
: TT has received honorarium from Merck Sharp & Dohme, Chugai, and AstraZeneca. OK and JS have nothing to disclose. MA reports honoraria from Roche, Pfizer, Amgen, and Merck & Co., Inc. MLQ reports travel expenses from Merck Sharp & Dohme, Roche, Pfizer, Ipsen, Astellas, Lilly, and AstraZeneca; advisory board participation for Roche, Boehringer Ingelheim, Bristol Myers Squibb, AstraZeneca, Takeda, Eusa Pharma, and Pfizer; and conference participation for Astellas, Vifor, Roche, AstraZeneca, Bristol-Myers Squibb, Janssen, Ipsen, and Pfizer. J-SL has nothing to disclose. MH reports a consulting or advisory role with IntegraConnect. MP reports advisory board participation for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck & Co., Inc., Merck Sharp & Dohme, Pfizer, Roche, and Takeda. LP-A reports honoraria from Advanced Accelerator Applications, Amgen, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Incyte Corporation, Ipsen, Merck & Co., Inc., Merck Sharp & Dohme, Novartis, Pfizer, PharmaMar, S.A., Roche, Sanofi, Servier Laboratoires, Sysmex Corporation, and Takeda; research funding from AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, and Pfizer; a leadership role at Altum Sequencing and is an officer/board of directors role at Genómica. LL, JD, and MM report employment and stock ownership with Incyte Corporation. AS and LX are salaried employees of Merck & Co., Inc., Rahway, NJ, USA and own stock in the company. CB reports no conflicts to disclose.