Exclusion of Patients with Autoimmune Disease in Lung Cancer Clinical Trials

Abstract

Background:The exclusion of patients with autoimmune disease has been a topic of cancer immunotherapy trial. This study aims to find recent trends in exclusion of autoimmune disease. Methods: Using the website clinicaltrials. gov, we searched for clinical trials that were initiated in 2012 or later and enrolled patients with lung cancer who were treated with PD-1/PD-L1 therapy. Only trials including US locations were analyzed. Results: A total of 198 trials met screening criteria in this study. There were 68 trials which had complete exclusion of any autoimmune disease in patients. In addition, 13 trials excluded active autoimmune disease and 87 trials excluded active autoimmune disease requiring treatment. The remaining 37 trials had undefined exclusion. Studies that had larger enrollment of patients with autoimmune diseases were largely in industry. The complete exclusion of patients with autoimmune diseases has decreased recently. Conclusion: Exclusion of patients with active autoimmune disease requiring treatment was one of the common exclusion criteria found. Strict exclusion of patients with autoimmune diseases has been decreasing over the years.

Sex and anti-inflammatory treatment affect outcome of melanoma and non-small cell lung cancer patients with rheumatic immune-related adverse events

“…Thus, in addition to the issues raised in this recent study, 30 our findings pave the way for future large randomized controlled trials addressing the fundamental question of whether and when DMARDs should be initiated in general. In particular, the finding of poorer PFS in patients with flares-a study population largely excluded from previous ICI clinical trials [52][53][54] -possibly due to a more extensive GC use owing to a more inflammatory and persistent phenotype compared with de novo R-irAEs, adds further relevance to this matter. 52 Collectively, the question of a suitable personalized (pre-)treatment strategy for patients with R-irAE with more severe and/or chronic courses needs to be urgently addressed in future randomized controlled cancer trials.…”