Primary and secondary endpoints for LUME-Lung1
•
PFS (primary endpoint):
The study has 90% power to
show a significant improvement in PFS with a HR of 0.7843
based on 713
centrally-assessed
progression events
At least one futility analysis for PFS planned when 50 % of the
primary PFS analysis (356 events)
•
OS (Key secondary endpoint):
The study has 80% power to
show a significant improvement in OS with a HR of 0.8475
based on 1151 deaths
•
Other secondary endpoints
Objective tumour response
by central review and tumour
shrinkage
PFS by investigator review
Safety and tolerability
Quality-of-life
