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Exclusion of Patients with Autoimmune Disease in Lung Cancer Clinical Trials
Shamsher S Khan1, Takefumi Komiya1
1Division of Hematology/ Oncology, University at Buffalo, United States.
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.
Insights
Cancer immunotherapy trials are increasingly including patients with autoimmune diseases. Strict exclusion criteria for autoimmune conditions in lung cancer trials have decreased over time, with fewer trials completely excluding these patients.
Area of Science:
- Oncology
- Immunology
- Clinical Trial Design
Background:
- Exclusion of patients with autoimmune diseases is a significant consideration in cancer immunotherapy trials.
- Understanding trends in these exclusion criteria is crucial for trial inclusivity.
Purpose of the Study:
- To investigate recent trends in the exclusion of patients with autoimmune diseases in cancer immunotherapy trials.
- To analyze the prevalence and nature of autoimmune disease exclusion criteria in lung cancer trials using PD-1/PD-L1 inhibitors.
Main Methods:
- A systematic search of clinicaltrials.gov was conducted for trials initiated from 2012 onwards.
- Trials involving lung cancer patients treated with PD-1/PD-L1 therapy and US locations were analyzed.
- Exclusion criteria related to autoimmune diseases were categorized and quantified.
Main Results:
- Out of 198 analyzed trials, 68 completely excluded patients with autoimmune diseases.
- 87 trials excluded patients with active autoimmune disease requiring treatment, while 13 excluded active autoimmune disease.
- The complete exclusion of patients with autoimmune diseases has shown a recent decrease, with industry-sponsored trials showing higher enrollment of such patients.
Conclusions:
- Exclusion of patients with active autoimmune disease requiring treatment is a common criterion.
- The trend indicates a gradual decrease in strict exclusion of patients with autoimmune diseases in cancer immunotherapy trials over the years.
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