pembrolizumab plus SoC (n=373) vs. placebo plus SoC (n=376)
randomized controlled trial
Pembrolizumab with cisplatin and 5 FU :
Pembrolizumab at 200 mg on day 1 of each 3-week cycle, for up to 35 cycles Cisplatin in both study arms is administered at a dose level of 50 mg/m2 on day 1 of each 3-week cycle for up to 6 cycles, and 5-FU was administered at 800 mg/m2 per day on day 1 to day 5 of each 3-week cycle for up to 35 cycles
placebo with cisplatin and 5 FU :
Cisplatin in both study arms is administered at a dose level of 50 mg/m2 on day 1 of each 3-week cycle for up to 6 cycles, and 5-FU was administered at 800 mg/m2 per day on day 1 to day 5 of each 3-week cycle for up to 35 cycles
mEC - 1st line (L1)
double-blind
across 168 medical centres in 26 countries
P3 / 1 IA and 1 final analysis: the 1st IA (= the final analysis of PFS) was planned after at least 13mo of follow-up. Overall type I error at a 1-sided at 0.25 with 0.12 to OS in patients with PD-L1> 10, 0.11 to ITT patients and 0.02 to PFS in ITT patients. Re-allocation of overall type I error to other outcomes according to graphical method p13 of the appendix