Mok, Tony S.
Cheng, Ying
Zhou, Xiangdong
Lee, Ki Hyeong
Nakagawa, Kazuhiko
Niho, Seiji
Chawla, Alka
Rosell, Rafael
Corral, Jesus
Migliorino, Maria Rita
Pluzanski, Adam
Noonan, Kay
Tang, Yiyun
Pastel, Malaika
Wilner, Keith D.
Wu, Yi-Long http://orcid.org/0000-0002-3611-0258
Funding for this research was provided by:
Pfizer
SFJ Pharmaceuticals
Article History
First Online: 17 December 2020
Declarations
:
: This study was sponsored by Pfizer Inc and SFJ Pharmaceuticals.
: Tony Mok: grant/research funding (paid to institution): AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, G1 Therapeutics, Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche, SFJ, Takeda, and XCovery; speaker’s fees: ACEA Pharma, Alpha Biopharma Co., Ltd., Amgen, Amoy Diagnostics Co., LTD., AstraZeneca (before Jan 2019), Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, InMed Medical Communication, Merck Sharp & Dohme, Novartis, Pfizer, PrIME Oncology, Roche/Genentech, Taiho, and Takeda Oncology; honoraria for consultation services: Abbvie Inc., ACEA Pharma (since Aug 2018), Alpha Biopharma Co., Ltd., Amgen, Amoy Diagnostics Co., Ltd., AstraZeneca (before Jan 2019), Bayer, Boehringer Ingelheim, Blueprint Medicines Corporation, Bristol-Myers Squibb, Celgene, CStone Pharmaceuticals, Daiichi Sankyo, Eli Lilly, Fishawack Facilitate Ltd., Hengrui Therapeutics Inc., Ignyta, Inc., Incyte Corporation, InMed Medical Communication, IQVIA, Janssen, Loxo-Oncology, Merck Serono, Merck Sharp & Dohme, MoreHealth, Novartis, OncoGenex Pharmaceuticals, Inc., OrigiMed, PeerVoice, Pfizer, PrIME Oncology, Roche/Genentech, Sanofi-Aventis R&D, SFJ Pharmaceutical Ltd., Takeda Pharmaceuticals HK Ltd., Vertex Pharmaceuticals, Yuhan Corporation, Medscape/WebMD (medical education/CME activities), PeerVoice (independent medical education), Prime Oncology (medical education); stock shareholder/option: Clearbridge Biomedics (now Biolidics Ltd.), Hutchison Chi-Med, Loxo-Oncology, OrigiMed Co. Ltd., Sanomics Ltd., and Virtus Medical Group; advisory board: Abbvie Inc., ACEA Pharma, Amgen, AstraZeneca, Bayer, Blueprint Medicines Corporation, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Cirina, CStone Pharmaceuticals, Daiichi Sankyo, Eli Lilly, Fishawack Facilitate Ltd., G1 Therapeutics, Inc., geneDecode Co., Ltd. (uncompensated), Hengrui Therapeutics Inc., Hutchison Chi-Med, Ignyta, Inc., Incyte Corporation, IQVIA, Janssen, Loxo-Oncology, Lunit, Inc., Merck Serono, Merck Sharp & Dohme, Novartis, OncoGenex Technologies Inc., OrigiMed, Pfizer, Roche/Genentech, Sanofi-Aventis R&D, SFJ Pharmaceutical, Takeda Oncology, Vertex Pharmaceuticals, Virtus Medical Group, and Yuhan Corporation; board of directors/leadership (remunerated): AstraZeneca and Hutchison Chi-Med; board of directors/leadership (non-remunerated): American Society of Clinical Oncology (ASCO), Asian Thoracic Oncology Research Group (ATORG), Chinese Lung Cancer Research Foundation Limited (CLCRF), Chinese Society of Clinical Oncology (CSCO), Hong Kong Cancer Fund (HKCF), Hong Kong Cancer Therapy Society (HKCTS), International Association for the Study of Lung Cancer (IASLC; term ended Apr 2019), and St. Stephen’s College & Prep. School. Kazuhiko Nakagawa: grants: MSD K.K., A2 Healthcare Corp., inVentiv Health Japan Astellas Pharm Inc., Daiichi Sankyo Co., Ltd., Novarits Pharma K.K., AbbVie Inc., Quintiles Inc., IQVIA Services JAPAN K.K., ICON Japan K.K., Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., EP-CRSU CO., LTD., GRITSONE ONCOLOGY.INC, Linical Co., Ltd., Eli Lilly Japan K.K., Eisai Co., Ltd., Bristol-Myers Squibb, Nippon Boehringer Ingelheim Co., Ltd., Taiho Pharmaceutical Co., Ltd., Pfizer Japan Onc., PAREXEL International Corp., SymBio Pharmaceuticals Limited, Ono Pharmacuetical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., EPS Corporation, Bayer Yakuhin Ltd., Syneos Health, EPS International Co., Ltd., Pfizer R&D Japan G.K., Otsuka Pharmaceutical Co., Ltd.; honoraria: AstraZeneca K.K., Nichi-Iko Pharmaceutical Co., Ltd., Astellas Pharma Inc., Takeda Pharmaceutical Co., Ltd., MSD K.K., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K., Novartis Pharma K.K., SymBio Pharmaceuticals Limited, Pfizer Japan Inc., Chugai Pharmaceutical Co., Ltd., Clinical Trial Co., Ltd., NANZANDO Co., Ltd., MEDICUS SHUPPAN Publishers Co., Ltd., YODOSHA CO., LTD., Care Net Inc., Nikkei Business Publications Inc., Reno Medical K.K., Daiichi Sankyo Co., Ltd., KYORIN Pharmaceutical Co., Ltd., Thermo Fisher Scientific K.K., Medical Review Co., Ltd., YOMIURI TELECASTING CORPORATION, Roche Diagnostics K.K., Nippon Kayaku Co., Ltd., Bayer Yakuhin Ltd., Merck Biopharma Co., Ltd., Medical Mobile Communications Co., Ltd., AbbVie Inc., 3H Clinical Trial Inc. Seiji Niho: grants: AstraZeneca, Pfizer, Merck Biopharma, Eli Lilly, MSD, and Chugai; honoraria: AstraZeneca, Pfizer, Eli Lilly, Chugai, Taiho, MSD, Bristol-Myers Squibb, Novartis, Boehringer Ingelheim, Taiho, Ono, and Shionogi. Alka Chawla: former employee of SFJ Pharmaceuticals. Jesus Corral: Education grants, provided consultation, attended advisory boards and/or provided lectures for Pfizer, AstraZeneca, Roche, Eli Lilly, MSD, and Bristol-Myers Squibb. Adam Pluzanski: lecture fees and travel grants: Pfizer. Kay Noonan, Yiyun Tang, Malaika Pastel, and Keith Wilner: Pfizer employees and stockholders. Yi-Long Wu: grants (to institute): AstraZeneca, BMS, Boehringer Ingelheim, Pfizer, and Roche; honoraria: AstraZeneca, Boehringer Ingelheim, MSD, and Roche; lectures/speakers bureaus: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, MSD, Pfizer, and Roche. Ying Cheng, Xiangdong Zhou, Ki Hyeong Lee, Rafael Rosell, and Maria Rita Migliorino: no conflicts of interest to declare.
: The study was conducted in accordance with legal and regulatory requirements, the general principles in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), and the Declaration of Helsinki (World Medical Association 1996 and 2008).
: Informed consent was obtained from all individual participants included in the study.
: Upon request, and subject to certain criteria, conditions and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: Not applicable.