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Article History

Received: 6 June 2019

Revised: 5 February 2020

Accepted: 17 February 2020

First Online: 12 March 2020

Ethics approval and consent to participate

: The studies were performed in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guideline for Good Clinical Practice. Approval was obtained from the Independent Ethics Committees (IECs) or Institutional Review Boards (IRBs) of the participating sites. For study 1280.1, these were the National Taiwan University Hospital Research Ethics Committee A, Taipei City, Taiwan (Reference: 201103051MA), the National Cheng Kung University Hospital Institutional Review Board, Tainan, Taiwan (Reference: BR-100–031), and the China Medical University Hospital Institutional Review Board, Taichung, Taiwan (Reference: DMR101-IRB1–052). For study 1280.2, these were the central IRB/IEC NRES Committee London – West London, UK (Reference: 11/LO/0063) and Leeds Teaching Hospitals NHS Trust, Research & Development, Leeds, UK (LTHT R&D number: MO11/9712). All patients provided written informed consent.

: To ensure independent interpretation of clinical study results, Boehringer Ingelheim grants all external authors access to all relevant material, including participant-level clinical study data, and relevant material as needed by them to fulfil their role and obligations as authors under the ICMJE criteria. Furthermore, clinical study documents (e.g. study report, study protocol, statistical analysis plan) and participant clinical study data are available to be shared after publication of the primary paper in a peer-reviewed journal and if regulatory activities are complete and other criteria met per the BI Policy on Transparency and Publication of Clinical Study Data: . Prior to providing access, documents will be examined, and, if necessary, redacted and the data will be 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. Clinical Study Reports and Related Clinical Documents can be requested via this link: . All such requests will be governed by a Document Sharing Agreement. Bona fide, qualified scientific and medical researchers may request access to de-identified, analysable participant clinical study data with corresponding documentation describing the structure and content of the datasets. Upon approval, and governed by a Data Sharing Agreement, data are shared in a secured data-access system for a limited period of 1 year, which may be extended upon request. Researchers should use to request access to study data.

: J.d.B.: consultancies for Astellas, AstraZeneca, Boehringer Ingelheim, Carrick, Daiichi, Genentech/Roche, GSK, MSD, Merck, Menarini, Serono, Sanofi Aventis, Shattuck and Taiho; received research grants from Astex, AstraZeneca, Daiichi, Genentech, GSK, Merck, MSD, Sanofi, and Serono. C.H.H.: consultancies for Bristol-Myers Squibb, Eli Lilly, MSD, Merck Serono, Novartis, Ono Pharmaceutical; received remuneration from Bristol-Myers Squibb, MSD, and Ono Pharmaceutical; received research funding from AstraZeneca, Bristol-Myers Squibb, Genentech, MSD, Merck Serono, Ono Pharmaceutical, and Taiho Pharmaceutical. A.A.: consultancies for Ono Pharmaceuticals and Advanced Accelerator Applications. S.B., R.F., U.S., R.G.G., D.C.L.H., N.S. and T.B.: employees of Boehringer Ingelheim. T.B.: owns stock in Roche, Seattle Genetics, Immunogen, Gilead, and Celgene. C.T.: consultancies for Pfizer, Nektar, and Daiichi; received remuneration from Pfizer, Roche, and Daiichi. J.C.H.Y.: consultancies for Boehringer Ingelheim, Eli Lilly, Bayer, Roche/Genentech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Celgene, Merrimack, Yuhan Pharmaceuticals, Bristol-Myers Squibb, Ono Pharmaceutical, Daiichi Sankyo, AstraZeneca, Takeda, and Hansoh Pharmaceuticals. L.T.C.: consultancies for Ono Pharmaceutical, BMS, MSD, Eli Lilly, PharmaEngine, Five Prime, Novartis, and Astra Zeneca; received patent royalties/licensing fees from HuniLife; received remuneration from Ono Pharmaceutical, Bristol-Myers Squibb, MSD, Eli Lilly, PhamaEngine, TTY, SyncoreBio, Five Prime, Novartis, Astra Zeneca, and Ipsen; received research funding from Novartis, Pfizer, Merck Serono, Polaris, TTY, SyncoreBio, Celgene, and BMS; Board Member of ScinoPharm Taiwan, Ltd. A.L.C.: consultancies for Novartis, Merck Serono, Eisai, Merck Sharp & Dohme (I.A.) Corp., Exelixis, Bayer HealthCare Pharmaceuticals Inc., Bristol-Myers Squibb Company, and Ono Pharmaceutical Co., Ltd.; received remuneration from Bayer, Eisai, Novartis, Eli Lilly, and MSD. The remaining authors declare no competing interests.

: The studies were supported by Boehringer Ingelheim. We received funding from ECMC and BRC grants to The Institute of Cancer Research and Royal Marsden. Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Fiona Scott, of GeoMed, an Ashfield company, part of UDG Healthcare plc, during the preparation of this article.