2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.122 Ivy Riano NACLC23 Abstract

PP01.122 Ivy Riano NACLC23 Abstract

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A study conducted by Ivy Riano et al. examined the inclusion criteria for patients with brain metastasis (BM) and leptomeningeal disease (LMD) in phase 3 clinical trials for non-small cell lung cancer (NSCLC). Historically, patients with central nervous system (CNS) metastases have been excluded from clinical trials. However, in October 2017, recommendations were made to include patients with BM in clinical trials.<br /><br />The researchers analyzed data from ClinicalTrials.gov from January 2013 to September 2023. They categorized each trial based on whether patients with BM were included, partially included, or excluded, as well as whether LMD was included or excluded. They also examined the inclusion of patients with BM/LMD pre- and post-recommendations.<br /><br />Among the 118 trials analyzed, most CTs partially included patients with BM (64.4%) and excluded them from 14.4% of trials. Only 2.5% of trials included patients with active/untreated BM. Patients with LMD were included in 5.1% of trials and excluded from 41.5% of trials. There were no significant differences in the inclusion of patients with BM/LMD pre- and post-recommendations.<br /><br />The study also found that patients with BM/LMD were more likely to be included in trials measuring CNS outcomes. However, there were no differences in the inclusion of patients with BM/LMD based on the type of drug intervention or funding source.<br /><br />Based on their findings, the researchers concluded that despite recommendations to broaden eligibility criteria, patients with BM/LMD are often conditionally excluded or partially included in NSCLC clinical trials. They emphasize the need for larger efforts to include these patients in clinical trials.

Keywords

brain metastasis

leptomeningeal disease

phase 3 clinical trials

non-small cell lung cancer

inclusion criteria

ClinicalTrials.gov

central nervous system metastases

recommendations

CNS outcomes

eligibility criteria