Abstract This is a systematic analysis of CNS reporting in clinical trials for patients with NSCLC and actionable genomic alterations (AGA). We evaluated clinical trials with enrollment beginning in 2001-2021 to encompass all FDA-approved therapies for NSCLC with AGA. Of 79 trials, 57 study protocols were publicly available. The preplanned analysis included: CNS disease eligibility, brain imaging schedule, allowance of post-progression therapy, and CNS efficacy reporting. Studies with enrollment starting between (11/01/01-10/31/11) and (01/01/21-11/30/21) were compared to analyze trends in CNS-specific trial design elements. There were 79 published trials and 57 available protocols initiating enrollment from November 2001 to November 2021. Brain metastases were allowed in 97.5% of trials (77/79), and LMD in 11.4% of trials (9/79). Symptomatic CNS disease was not formally defined in any trial. Baseline corticosteroids were allowed in 27.3% of trials (21/77). Washout time for stereotactic radiation therapy ranged from 1 week (10.8%; 8/74), 2 weeks (52.7%; 39/74), 3 weeks (1.4%; 1/74), 4 weeks (20.3%; 15/74), 8 weeks (1.4%; 1/74), and not specified (13.5%; 10/74). On study brain imaging was mandated for all patients in 18.9% of trials (15), only for those with known brain metastases in 55.7% of trials (44), and not specified in 25.3% of trials (20). Allowance of local therapy for CNS oligoprogression was permitted in 29.1% of trials (23), not permitted in 16.5% of trials (13), and not specified in 54.4% of trials (43). RANO-BM was used in 6.3% of trials (5) while RECIST in 93.7% of trials (74). In the most recent 10 years, there is an increase in baseline brain imaging, allowance of asymptomatic untreated brain metastases, and an increase in reporting of systemic and intracranial efficacy. Our study highlights that uniform inclusion criteria, brain imaging requirements, stereotactic radiation therapy washout period, and CNS efficacy reporting are pertinent for future studies.
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