2019 ASCO: Expansion of Clinical Trial Inclusion Criteria in Patients With Advanced NSCLC
A study that examined 10,500 health records of patients with advanced non–small cell lung cancer from ASCO’s CancerLinQ database found that the use of expanded clinical trial inclusion criteria—as proposed by ASCO and Friends of Cancer Research in 2017—would nearly double the percentage of patients eligible to enroll in clinical trials—from 52.3% to 98.5%. The expanded clinical trial eligibility criteria would allow patients with advanced NSCLC and brain metastases, previous or concurrent cancers, and limited kidney function to enroll in clinical trials. These findings were presented by Harvey et al at the 2019 ASCO Annual Meeting (Abstract LBA108).
“Ongoing use of historic, narrow eligibility criteria based on antiquated safety concerns place potentially unnecessary restrictions on trial participants, thus making it increasingly difficult to conduct the clinical trials necessary to demonstrate safety and efficacy of new therapies,” said lead study author R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, Director of the Phase I Clinical Trials Unit at Winship Cancer Institute of Emory University. “Changes to eligibility criteria are particularly important as we step further into the era of targeted therapies, including immunotherapies, that have different safety profiles than highly toxic systemic chemotherapies.”
In November 2018, the National Cancer Institute revised its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials based on the recommendations of ASCO and Friends of Cancer Research. More time is needed, however, to assess whether these broader criteria are being widely adopted.
Analysis
Researchers looked at electronic health records in ASCO’s CancerLinQ database from 2011 to 2018, and focused on adults with advanced NSCLC who had two or more oncologist visits and at least one dose of a systemic treatment after diagnosis. Using these data, researchers evaluated the number of patients eligible for clinical trials using traditional criteria and using the proposed criteria from ASCO and Friends of Cancer Research, which would allow for brain metastases, previous or current cancer diagnoses, and creatinine clearance levels as low as 30 mL/min.
Overall, 60% of the patients had stage IV disease, and 80% were former or current smokers. The median age of patients was 67.6 years; 56% were male and 44% were female.
Results
When the researchers applied traditional clinical trial enrollment criteria, 5,005 (47.7% of patients) would have not met trial eligibility criteria. If, however, expanded criteria were adopted, only 154 (1.5% of patients) would have not met eligibility criteria. Use of the expanded criteria would allow 4,851 more people to meet these eligibility criteria, resulting in nearly twice as many people with advanced NSCLC who would be able to enroll in a trial.
Adoption of expanded criteria compared with traditional criteria would also enhance the characteristics of patients with advanced NSCLC participating in trials in the following ways:
- Older patients, raising the median age from 66.1 to 67.5 years
- More female patients, raising the percentage from 40% to 44%
- Stage IV diagnoses, raising the percentage from 55% to 60%
- Nonsquamous types of lung cancer, raising the percentage from 45% to 47%
- Never-smokers, raising the rate from 13% to 16%.
Next Steps
Researchers are currently performing other analyses to look at differences between people who have been treated for their disease and remained stable and people with ongoing brain metastases. The researchers are also doing subanalyses to further refine which patients would be eligible for modern-day clinical trials. They noted that none of these efforts would be possible without the use of ‘big data’ via CancerLinQ.
Dr. Harvey remarked that what is most needed is greater knowledge about drug-specific and population-specific outcomes in this disease in order to quickly and safely expand eligibility criteria. Expanded eligibility should also help to reduce disparities in enrollment, both socially and economically, he concluded.
Disclosure: This study received funding from ASCO. For full disclosures of the study authors, visit coi.asco.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
