2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.122 (Poster) Inclusion of Patients with Brain Metastases and Leptomeningeal Disease in Phase 3 Lung Cancer Clinical Trials: Time for Action

PP01.122 (Poster) Inclusion of Patients with Brain Metastases and Leptomeningeal Disease in Phase 3 Lung Cancer Clinical Trials: Time for Action

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A study examined the inclusion of patients with brain metastases (BM) and leptomeningeal disease (LMD) in phase 3 clinical trials for non-small cell lung cancer (NSCLC). Historically, these patients have been excluded from trials. However, in October 2017, recommendations were made to include them. The researchers analyzed data from ClinicalTrials.gov, excluding trials registered within one year after the recommendations to allow for adoption time. They categorized the eligibility criteria for each trial as "included", "partially included", or "excluded" for patients with BM and LMD.<br /><br />The study found that despite existing recommendations to broaden trial eligibility criteria and the high incidence of CNS metastases in NSCLC, patients with BM and LMD are often conditionally excluded or only partially included in phase 3 trials. Patients with LMD were included in only 5.1% of trials and excluded from 41.5% of trials. There were no significant differences in the inclusion of BM and LMD patients pre- and post-recommendations.<br /><br />However, patients with BM and LMD were more likely to be included in trials that measured CNS outcomes. The study suggests that larger efforts should be made to broaden trial eligibility criteria and include patients with BM and LMD in NSCLC. The data presented in the study indicates the need for action and highlights the need to address the exclusion of these patient populations in clinical trials.

Asset Subtitle

Ivy Riano

Keywords

patients

brain metastases

leptomeningeal disease

phase 3 clinical trials

non-small cell lung cancer

recommendations

eligibility criteria

ClinicalTrials.gov

CNS metastases

action