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© W O N D ER IS LA N D / SH U TT ER ST O C K .C O M P roposed criteria that would expand clinical trial inclusion would nearly double the enrollment of patients with lung cancer, increasing the percentage from 52.3% to 98.5%, according to a study presented at the 2019 American Society of Clinical Oncology (ASCO) annual meeting in June. Researchers evaluated 10,500 health records of patients with advanced non– small cell lung cancer (aNSCLC) from ASCO’s CancerLinQ database, which collects and analyzes patient data from practices nationwide. They then applied expanded inclusion criteria proposed by ASCO and Friends of Cancer Research in 2017. The expanded criteria would allow for the participation of aNSCLC patients with brain metastases, previous or concurrent cancers, and limited kidney function in clinical trials. Nationally, just approximately 3% of patients with cancer participate in clinical trials because of highly restrictive eligibility criteria. According to Donald Harvey, PharmD, the study’s lead author and director of the phase 1 clinical trial program at Emory University’s Winship Cancer Institute in Atlanta, Georgia, updating trial eligibility criteria is particularly important as more personalized therapies are being studied. Immunotherapy, for example, does not have the same safety profile as highly toxic systemic chemotherapy, so different criteria should be considered for studies evaluating its effectiveness. On the basis of the ASCO and Friends of Cancer Research expanded criteria recommendations, the National Cancer Institute revised its clinical protocol template to broaden eligibility criteria in November 2018. However, more time is needed to determine whether these new criteria are being adopted nationwide. Assessing electronic health records from the CancerLinQ database from 2011 to 2018, Dr. Harvey and his colleagues analyzed adult patients with aNSCLC who had visited oncologists at least twice and had at least 1 systemic treatment dose after diagnosis. They then evaluated the number of patients eligible for clinical trials according to traditional eligibility criteria as well as the proposed ASCO and Friends of Cancer Research criteria. In addition to brain metastases and a previous or current cancer diagnosis, the latter allow creatinine clearance levels as low as 30 mL/min. This measure can indicate kidney damage or impairment. In contrast, traditional criteria exclude patients with creatinine clearance levels of 60 mL/min. With the traditional criteria, 47.7% of the evaluated patients in the study would be unable to enroll in a trial. Expanding the criteria, however, would prevent only 1.5% of patients from enrolling. As a result, the broader criteria would enable 4851 more people—nearly twice as many—to enroll in a clinical trial, the researchers found. Furthermore, using the expanded criteria among these patients would: 1. Enable greater numbers of older patients to enroll and raise the age from 66.1 to 67.5 years. 2. Increase the percentage of female participants from 40% to 44%. 3. Include more patients with stage 4 diagnosis and increase their percentage from 55% to 60%. 4. Raise the percentage of participants with nonsquamous types of lung cancer from 45% to 47%. 5. Increase the percentage of never-smoker participants from 13% to 16%. Dr. Harvey adds that expanding criteria would help to reduce enrollment disparities both socially and economically. Researchers are also analyzing the differences between patients who have been treated for their disease and remained stable and patients with ongoing brain metastases. Furthermore, they are assessing which patients in the study would be eligible for modern-day clinical trials.