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Article History

Received: 19 September 2018

Accepted: 4 February 2019

First Online: 11 March 2019

Ethics approval and consent to participate

: The study protocol was approved by the institutional ethics committee at participating sites; the study was conducted in accordance with the 2008 Declaration of Helsinki. All patients (intention-to-treat [ITT] population) provided written informed consent; patients in the correlative cohort signed an optional consent form relating to primary tumor collection for exploratory biomarker analyses.

: Not applicable

: SKLC received honoraria from Novartis, Hoffmann-La Roche, Pfizer, and AstraZeneca. MM received grants and personal fees from Roche/Genentech, Novartis, Amgen, AstraZeneca, Pfizer, Pharmamar, and Lilly. BE received research funding from NanoString, Novartis, and Roche, and travel, accommodations, or expenses from AstraZeneca. SD received honoraria from Puma, Pfizer, AstraZeneca, Roche, and Lilly; consulting or advisory role from Puma, Pfizer, AstraZeneca, Roche, and Lilly; research funding from Puma, Pfizer, AstraZeneca, Roche, and Lilly; and travel and accommodations expenses from Pfizer, Roche, and AstraZeneca. BM acted in a consulting or advisory role (immediate family member) for Motus GI. HI received honoraria from Chugai, AstraZeneca, and Eisai, and consulting or advisory role for Chugai, Pfizer, Daiichi-Sankyo, AstraZeneca, and Lilly. GvM received research funding from Pfizer, Amgen, Roche, Teva, Novartis, AstraZeneca, Celgene, Myriad, AbbVie, and Vifor. JM received research funding from Roche, Macrogenics, and Puma Biotechnology Inc. CHB received grants and personal fees from GlaxoSmithKline, Roche, and Novartis outside the submitted work. MG received research funding from Sanofi-Aventis, Pfizer, Smith Medical, Novartis, Roche, GlaxoSmithKline, and personal fees from Novartis, Roche, GlaxoSmithKline, AstraZeneca, Nanostring Technologies, and Accelsiors. ND received research funding from Amgen and Genentech. SBK received research funding from Novartis, Sanofi-Aventis, Kyowa-Kirin Inc., and Dongkook Pharma Co. Ltd. NR acted in a consulting or advisory role for New Century Health and Bristol-Myers Squibb and received research funding from Side-Out Foundation. JS II acted in a consulting or advisory role for BMS and Novartis. BZ, LDE, and ASL are employed by Puma Biotechnology, Inc. MB is employed by the International Drug Development Institute (IDDI) and holds stock of IDDI. YY was employed by Puma Biotechnology at the time of the research but is now employed by QED Therapeutics Inc. FAH, ZT, RS, EHJ, VH, GH, and AC declare that they have no competing interests.

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