Introduction: In- and exclusion criteria of randomized clinical trials (RCTs) aim to include a homogeneous study-population. This study compared characteristics of lung cancer patients from phase III RCTs evaluating tyrosine kinase inhibitors (TKIs) or immune checkpoint inhibitors (ICIs) with characteristics of lung cancer patients in a real world setting in the United Kingdom. Methods: A retrospective study was conducted using the Clinical Practice Research Datalink GOLD. Patients (N = 9239) with a first ever lung cancer registration between 2014 and 2018 were identified. Eligibility for inclusion was assessed for twelve RCTs (evaluating TKIs or ICIs). Reasons for potential exclusion and the number of unmet criteria were assessed for each RCT independently. OS was assessed using Kaplan-Meier and Cox proportional hazards analyses. Results: The proportion of potentially eligible patients was 74.3% and 51.9% for TKI and ICI RCTs, respectively. History of another malignancy, renal insufficiency or concomitant drug-use were main reasons for exclusion. OS was considerably longer for potentially eligible patients. Hazards ratios varied from 1.17 (95% confidence interval, 1.11–1.24) to 1.35 (1.20–1.42) across the RCTs. Conclusion: This study showed that a considerable proportion of lung cancer patients in a real-world setting would have been ineligible for participation in phase III RCTs and that potentially ineligible patients experienced a shorter OS.
Bibliographical noteFunding Information:
None. AV and FV initiated the study and were responsible for the study concept and design. AV did the literature review and wrote the first draft of the paper. AV and PS analysed the data and was in a later stage QA-ed by JD. AV, PS and FV had full access to all of the data in the study. All authors participated in the interpretation of the data and critically revised the paper for intellectual content. All authors approved the final version to be published. AV and PS take responsibility for the integrity of the data and accuracy of the data analyses. FV is accountable for all aspects of the work.
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