2.1. Study Design and Population
NSCLC, colorectal cancer, ICH, coronavirus disease, weight loss, CRC) stage IIB
NON-SMALL CELL LUNG CANCER, COLORECTAL CANCER, RECRUITMENT, NSCLC, ONCOLOGY
This randomised (2:1), controlled, open-label, parallel-group, multi-centre and multi-country study was carried out across five countries (Belgium, Estonia, Lithuania, the Netherlands and Norway) in nine hospital sites.The study population comprised subjects (age ≥ 18 years) with histologically proven colorectal cancer (CRC) stage IIB, III or IV or histologically or cytologically proven non-small cell lung cancer (NSCLC) stage III or IV and who were scheduled for first-line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks. Subjects were also required to have a performance status Eastern Cooperative Oncology Group (ECOG) score of either 0 or 1 and be able to provide written informed consent to take part in the study. Exclusion criteria included weight loss of >10% in the last 6 months and BMI < 20.0 kg/mThe study was conducted according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) principles and in compliance with the ‘World Medical Association Declaration of Helsinki’ (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and with the local laws and regulations of the countries where the study was performed. The protocol was submitted to the local ethics committees and approved prior to the start of the study. The study was registered in the This study was affected by the coronavirus disease (COVID-19) outbreak, which meant that recruitment stopped in March 2020 and restarted 2–5 months later depending on the study site.