ipilimumab plus SoC (n=479) vs. placebo plus SoC (n=477)
randomized controlled trial
ipilimumab plus paclitaxel and carboplatin
ipilimumab 10 mg/kg or placebo IV given every 12 weeks
placebo plus paclitaxel and carboplatin
ipilimumab matched placebo IV given every 12 weeks and paclitaxel 175 mg/m2 plus carboplatinarea under the concentration-time curve 6, both given intravenously (IV) every 3 weeks for six 3-week cycles
treatment given as induction and maintenance. No subject crossover between treatment arms is allowed in this study.
squamous - mNSCLC - L1 - all population
double blind
233 sites in 34 countries
P3 / two-sided test procedure with no formal interim analysis. Hierachical testing procedure with secondary endpoint : OS (ITT) then PFS. Study with randomization at the beginning of the induction period is inappropriate to evaluate only maintenance treatment interest.
The addition of ipilimumab to first-line chemotherapy did not prolong OS compared with chemotherapy alone in patients with advanced squamous NSCLC.