Dr. Kelly on Window-of-Opportunity Monotherapy Trials in Lung Cancer

Karen Kelly, MD, associate director for Clinical Research at the University of California (UC) Davis Comprehensive Cancer Center, Jennifer Rene Harmon Tegley and Elizabeth Erica Harmon Endowed Chair in Cancer Clinical Research, and a professor of medicine at UC Davis Health, discusses the experimental window-of-opportunity studies with monotherapies in lung cancer.

Right now, window-of-opportunity studies remain very experimental, says Kelly. Two small phase 2 trials examining monotherapy in lung cancer. A larger trial, LCM3, enrolled 180 patients with locally advanced non–small cell lung cancer who underwent treatment with atezolizumab (Tecentriq); however, the rest of the studies reported have been very small.

The field did see some evidence of major pathologic response, although this is a surrogate that needs to be validated in this setting of neoadjuvant therapy because that is the earliest time point for efficacy, explains Kelly.

The next time point would be disease-free survival and finally overall survival (OS), but the wait for OS read-outs is very long, says Kelly. Major pathologic response has been the primary end point for most of these window-of-opportunity studies, concludes Kelly.