Eligibility criteria in phase 3 randomized controlled trials in metastatic non-small cell lung cancer.

BACKGROUND

The purpose of this study was to assess the eligibility criteria in randomized controlled trials (RCTs) in metastatic non-small cell lung cancer (NSCLC).

METHODS

Eligible trials were phase 3 RCTs of systemic treatments for metastatic NSCLC, registered with the World Health Organization International Clinical Trials Registry Platform and started between 2009 and 2023. The odds of selected eligibility criteria were determined with multivariable logistic regression. Trends in the use of the eligibility criteria over time were assessed with the Fisher's exact test.

RESULTS

A total of 274 of 386 trials (71%) excluded patients with an Eastern Cooperative Oncology Group (ECOG) score of >1; the odds of excluding these patients were higher in RCTs of chemotherapy (adjusted odds ratio [aOR], 3.46; 95% CI [confidence interval], 1.91-6.50; p < .001) and immunotherapy (aOR, 3.31; 95% CI, 1.58-7.21; p = .001) and in recent trials (aOR, 1.83; 95% CI, 1.09-3.10; p = .02). A total of 95 of 386 trials (24.6%) had an upper age limit of 85 years or younger; this was more likely in trials performed in Asia (aOR, 8.83; 95% CI, 3.27-28.24; p < .001). The proportion of trials with eligibility criteria concerning comorbidities did not significantly decrease over time (p > .05). None of the trials had any eligibility criteria concerning frailty.

CONCLUSIONS

The eligibility criteria in phase 3 RCTs in metastatic NSCLC continue to be strict. In some trials, judicious modifications of these criteria should be considered to improve the enrollment of clinically relevant populations of patients, especially older adults, individuals with an ECOG score of 2, and those with selected comorbidities.