CheckMate 227 (NI vs C ; PDL1>1%), 2018 NCT02477826
nivolumab plus ipilimumab (n=396) vs. pemetrexed plus platin (n=397)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab (3 mg per kilogram of body weight every 2 weeks) plus ipilimumab (1 mg per kilogram every 6 weeks)
platinium chemotherapy
platinum doublet chemotherapy based on tumor histologic type every 3 weeks for up to four cycles : pemetrexed (500 mg per square meter of body-surface area) plus cisplatin (75 mg per square meter) or carboplatin (area under the concentration-time curve [AUC], 5 or 6), every3 weeks for up to four cycles
3 arms: Nivolumab, or Nivolumab Plus Ipilimumab. Crossover between treatment groups within the trial was not permitted.
mNSCLC - L1 - PDL1 positive
Patients with known EGFR mutations or ALK translocations sensitive to targeted therapy, an autoimmune disease, or untreated central nervous system metastases were excluded
open label
NA
P3/ two sided and one interim analysis. Repartition between coprimary end point and hierarchy with secondary endpoint. WARNING safety from ITT population
Progression-free survival was significantly longer with first-line nivolumab plus ipilimumab than with chemotherapy among patients with NSCLC and a high tumor mutational burden, irrespective of PD-L1 expression level