Methods
WEST, MAY
The study was approved by the regulatory authorities, the Yorkshire & The Humber - Leeds West Research Ethics Committee, Jarrow, UK and the local ethics committees for each site. The study was conducted in accordance with ICH-GCP guidelines, the Declaration of Helsinki and all legal, regulatory, and data protection requirements. All patients provided written informed consent prior to participation.Patients were recruited at sites in the UK and the USA by suitably qualified investigators with experience in oncology clinical trials. Patient enrollment dates were from 14 November 2017 to 07 May 2020 in Module 1A, from 19 January 2019 to 14 May 2021 in Module 1B-1, and from 12 November 2019 to 04 April 2022 (cut-off date for data analysis) in Module 2A. Patients were recruited in a non-randomized open-label fashion based on the investigator’s pool of potential patients. Patients were then screened against the inclusion/exclusion criteria and included if eligible.All data were collected using IBM Clinical Development Version 2019.3.0.1 and SAS System Version 9.1 was used for the data analysis.