Corey J. Langer, MD, Professor of Medicine, Director, Thoracic Oncology, Abramson Cancer Center, University of Pennsylvania, discusses the design and major criticisms of the JMEN phase III trial.

JMEN was a randomized trial looking at maintenance pemetrexed in advanced or metastatic (stage IIIB and IV) non-small-cell lung cancer. The trial examined patients that had been treated with platinum-based first-line chemotherapy and were stable or had not progressed. JMEN demonstrated a significant survival benefit and was heralded as a paradigm changing trial.

The largest criticism of the trial was the absence of a mandatory crossover from the control arm to intravenous pemetrexed. 67% of patients on the placebo arm received a second-line therapy, of this amount only 19% received pemetrexed, the remaining 81% received an EGFR TKI or docetaxel.

Langer believes that receiving second-line pemetrexed alone should have been built into the trial. If this had happened the trial could have prevented major criticism.