Primary endpoint
deaths
EVENTS, PROGRESSION, DISEASE PROGRESSION
Until the time of analysis, 42 events (5 deaths and 37 disease progressions) had occurred and 5 patients were censored due to starting a second line treatment outside of the trial. The Kaplan–Meier estimator for PFS12m was 13% with a one-sided 90% CI of 7%. The corresponding 95% CI is [5%, 25%].As the lower boundary of the one-sided 90% confidence interval was smaller than 0.25, the null hypothesis cannot be rejected and the primary endpoint was not reached. Median PFS was 3.5 months, 95% CI [1.9, 5.4] (Fig. Progression free survival in the full analysis set.This was also observed in the subgroup analysis according to EGFR expression: PFS12m was 13%, 95% CI [1%, 42%] in the EGFR + subgroup and 13%, 95% CI [4%, 26%] in the EGFR++/+++ subgroup (Fig. Progression free survival in the full analysis set according to EGFR status.