The use of expanded eligibility criteria would allow nearly twice as many people with non-small cell lung cancer to participate in clinical trials, according to data presented at ASCO Annual Meeting.
The study is the result of a joint project between ASCO and the nonprofit advocacy group Friends of Cancer Research, which issued recommendations for expanding clinical trial access.
“Opening up clinical trial eligibility would allow more patients to participate in clinical trial research, and the data generated will be more generalizable to the population of individuals that we see in the clinic,” R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, director of the Winship Cancer Institute’s phase 1 clinical trials section and associate professor at Emory University School of Medicine, said during a press conference. “It will accelerate accrual to these clinical trials and will bring new therapies to these patients more quickly.”.
Harvey said that several groups are implementing the expanded criteria recommended by ASCO, including the FDA, NCI and National Clinical Trials Network.
The researchers conducted a retrospective study of 10,500 patients who received treatment after a diagnosis of advanced NSCLC from January 2011 to December 2018.
The purpose of the study was to determine the number of patients who would be excluded from a trial when comparing traditional study criteria with expanded criteria recommended by ASCO and Friends of Cancer Research.
The traditional clinical trial exclusion criteria used in this analysis were:
patients with another primary cancer within 2 years of trial enrollment;
patients with brain metastases; and
patients with creatinine clearance less than 60 mL/min.
The broadened eligibility criteria recommended by ASCO would allow enrollment of patients with another primary cancer if participation in the trial would not interfere with the patient’s safety or the efficacy of the therapy being tested. It would also allow patients with treated and/or stable brain metastases and patients with a creatinine clearance of 30 mL/min or greater if they would not experience kidney toxicity.
The study used anonymized electronic health records from the ASCO CancerLinQ Discovery database. NSCLC was chosen because of the availability of many scientific trials for the disease state and because patients with NSCLC often have more advanced stages of the disease and comorbidities.
The study group’s median age was 67.6 years (interquartile range, 60.3-74.4 years); most participants were men (56%), white (60%), former smokers (80%) and had stage IV NSCLC (60%).
The results showed that nearly half (47.7%) of patients in the study would have been prohibited from clinical trial participation using traditional exclusion criteria. Conversely, only 1.5% of the study population would have been excluded using the broadened criteria recommended by ASCO.
The traditional criteria would have excluded 21.2% of patients because of brain metastases, 14.4% because of previous cancer and 21.5% because of inadequate creatinine clearance. Creatinine clearance level was the only criterion resulting in the exclusion of patients in the study group when evaluated against the broadened trial participation requirements.
Patients who were eligible due to the expanded criteria were older (67.5 vs. 66.1 years; P < .001) and more likely to be female (44% vs. 40%), have stage IV disease (60% vs. 55%) and have never smoked (16% vs. 13%).
“Narrower criteria to exclude patients from clinical trials should only be used based on compelling scientific rationale,” Harvey said. “At this point, ASCO and the Friends of Cancer Research urge all clinical trial sponsors to adopt these criteria.”