Older Adult Participation in Early-Phase Lung Cancer Clinical Trials, 1998 to 2020.

OBJECTIVES

Despite advances, lung cancer treatment remains associated with substantial toxicity. Early-phase clinical trials inform the safety and efficacy of novel lung cancer treatments. Although older adults represent most patients with lung cancer, and they are underrepresented in phase 3 trials, age disparity in early-phase lung cancer trials is ill-defined.

METHODS

We queried ClinicalTrials.gov to identify early-phase interventional clinical trials conducted in adults with lung cancer since database conception. We calculated the difference in age (DA) between the clinical trial populations and U.S. populations, using test and one-sided analysis of variance to evaluate trial characteristics associated with DA.

RESULTS

We identified 141 clinical trials enrolling 7723 participants from 1998 to 2020. Early-phase lung cancer trial participants were, on average, 7.6 years younger than patients with lung cancer in the U.S. population (mean DA: -7.6 y, SD 4.2). Age disparities were magnified among clinical trials that were industry-sponsored (mean DA -8.5 versus -6.1, = 0.001) and those limiting eligibility to Eastern Cooperative Oncology Group performance status less than or equal to 1 (mean DA -8.0 versus -6.0, = 0.040). There was no association between the median age of trial participants and the proportion of patients with serious adverse events.

CONCLUSIONS

Older adults remain underrepresented in early-phase lung cancer clinical trials. With the rapid expansion of novel cancer therapies, focused efforts in the design of early-phase trials are warranted to reflect real-world populations. Otherwise, limitations in the generalizability of treatment safety and efficacy may increase in the future.