Molife, Cliff http://orcid.org/0000-0001-8993-7024
Cho, Jae Min http://orcid.org/0000-0003-4157-1822
Lapthorn, Jennifer http://orcid.org/0000-0002-6768-2750
Kang, Min Ju
D’yachkova, Yulia http://orcid.org/0000-0002-7435-2426
Kim, Sangmi
Colman, Sam
Kim, Saerom
Szende, Agota
Park, Ji Hyun
Ahn, Hee Kyung http://orcid.org/0000-0001-7786-7233
Hong, Min Hee http://orcid.org/0000-0003-3490-2195
Taipale, Kaisa-Leena
Kim, Hye Ryun http://orcid.org/0000-0002-1842-9070
Funding for this research was provided by:
Eli Lilly and Company
Article History
Accepted: 6 November 2022
First Online: 2 December 2022
Declarations
:
: JL, SC and AS, employees of Labcorp Drug Development, conducted contract research for Eli Lilly and Company. JMC, MJK, YD and SK are employees of Eli Lilly and Company. CM and KLT are employees and shareholders of Eli Lilly and Company. CM manufactures ramucirumab indicated in combination with erlotinib for treatment of <i>EGFR</i>m+ NSCLC. HKA reports consulting fees and honoraria from Eisai Korea, Yuhan, Boryung, Everest medicine, Hanmi, Daiichi Sankyo, BMS, MSD, Eli Lilly and Company, Boehringer Ingelheim, Roche and Pfizer. JHP, MHH and HRK have nothing to disclose.
: CM, JMC, JL, YD, SK, SC, AS conceived and designed the analysis. JL, SC and AS collected the data. JL, YD, SK, SC and AS contributed data or analysis tools. JL and SC performed the analysis. CM, JC and YD interpreted the study data, wrote and provided intellectual contribution to the study manuscript. JL, MJK, SK, SC, SK, AS, JHP, HKA, MHH, KLT, HRK interpreted study data and provided intellectual contribution and critical revision of the study manuscript. All authors read and approved the final version.
: Funding for this study was provided to Covance Inc. (now LabCorp Drug Development Inc.) by Eli Lilly and Company.
: Institutional Review Board (IRB) approval of the study protocol and questionnaire was obtained with waiver of informed consent (Advarra IRB) as this was a noninterventional study using deidentified, routinely collected data.
: Lilly provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at ExternalRef removed.