Tu, Hai-Yan
Feng, Jifeng
Shi, Meiqi
Zhao, Jun
Wang, Yuyan
Chang, Jianhua
Wang, Jialei
Cheng, Ying
Zhu, Jing
Tan, Eng-Huat
Li, Kai
Zhang, Yiping
Lee, Victor
Yang, Cheng-Ta
Su, Wu-Chou
Lam, David Chi-Leung
Srinivasa, B. J.
Rajappa, Senthil
Ho, Ching-Liang
Lam, Kwok Chi
Hu, Yi
Bondarde, Shailesh Arjun
Liu, Xiaoqing
Tian, Yahui
Xue, Zhiyi
Cseh, Agnieszka
Huang, Dennis Chin-Lun
Zhou, Caicun
Wu, Yi-Long http://orcid.org/0000-0002-3611-0258
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Phase IIIb Open-Label, Single-Arm Study of Afatinib in EGFR TKI-Naïve Patients with EGFRm+ NSCLC: Final Analysis, with a Focus on Patients Enrolled at Sites in China
https://doi.org/10.1007/s11523-021-00859-6
Funding for this research was provided by:
Boehringer Ingelheim Inc
Article History
Accepted: 22 November 2021
First Online: 12 January 2022
Declarations
:
: This work was supported by Boehringer Ingelheim International GmbH. The study sponsor participated in the design of the study, the collection, analysis, and interpretation of the data, writing the article, and the decision to submit the article for publication.
: Y-LW reports receiving honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Hengrui, Merck Sharp & Dohme, Pfizer, Roche, Sanofi; and receiving grants or funds from AstraZeneca, BMS, and Pfizer. KCL declares receiving honoraria (outside the submitted work) from Pifzer, AstraZeneca, Eli Lily, Roche. YT is employed by Boehringer Ingelheim (China) Investment Co., Ltd. ZX is employed by Boehringer Ingelheim (China) Investment Co., Ltd. AC was employed by Boehringer Ingelheim International GmbH. DC-LH was employed by Boehringer Ingelheim Taiwan Limited and is currently employed with Merck Sharp & Dohme (I.A.) LLC, Taiwan Branch. All the remaining authors declare no potential conflicts of interest.
: At each participating center, the study was approved by the Institutional Review Board or Independent Ethics Committee, and was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice, and local laws. All patients provided written informed consent.
: All patients provided written informed consent.
: To ensure independent interpretation of clinical study results, Boehringer Ingelheim grants all external authors access to relevant material, including participant-level clinical study data, as needed by them to fulfill their role and obligations as authors under the ICMJE criteria. Clinical study documents and participant clinical study data are available to be shared on request after publication of the primary manuscript in a peer-reviewed journal, and if regulatory activities are complete and other criteria met as per the BI Policy on Transparency and Publication of Clinical Study Data (see ExternalRef removed). Bona fide, qualified scientific and medical researchers are eligible to request access to the clinical study data with corresponding documentation describing the structure and content of the datasets. Upon approval, and governed by a Legal Agreement, data are shared in a secured data-access system for a limited period of 1 year, which may be extended upon request. Prior to providing access, clinical study documents and data will be examined, and, if necessary, redacted and de-identified, to protect the personal data of study participants and personnel, and to respect the boundaries of the informed consent of the study participants. Researchers should use the ExternalRef removed link to request access to study data and visit ExternalRef removed for further information.
: All authors critically reviewed and drafted the manuscript, and agreed to be accountable for all aspects of the work. AC contributed to the development of the draft at all earlier stages, all other authors provided feedback on the final version of the manuscript.