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nivolumab plus ipilimumab plus SoC (n=361) vs. Standard of Care (SoC) (n=358)
randomized controlled trial
nivo plus ipi and chemo (2 cycle)
nivolumab (360 mg intravenously every 3 weeks) plus ipilimumab (1 mg/kg intravenously every 6 weeks) combined with histology-based, platinum doublet chemotherapy (intravenously every 3 weeks for two cycles; experimental group)(permetrexed plus platine or paclitaxel and carboplatine)
chemotherapy platine combination
4 cycles of chemotherapy combination (permetrexed plus platine (68.8%) or paclitaxel plus carboplatine(31.2%))
Pts with nonsquamous NSCLC in the chemo-only arm could receive optional pemetrexed maintenance. Crossover between the treatment groups was not permitted;
mNSCLC - L1 - all population
Exclusion criteria included known EGFR mutations and ALK translocations that were sensitive to targeted therapy
open label
103 hospitals in 19 countries
P3 / two sided with one interim analysis. Hierarchical testing procedure with primary endpoint OS and secondary endpoints PFS then ORR
AI 1 stopped : a statistically significant improvement in OS, PFS and ORR was observed with NIVO plu IPI in with a limited course of chemo vs chemo (4 cycles) in 1L advanced NSCLC.
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
nivolumab plus ipilimumab (n=139) vs. pemetrexed plus platin (n=160)
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 - TMB>10Mb
Patients with known EGFR mutations or ALK translocations sensitive to targeted therapy, an autoimmune disease, or untreated central nervous system metastases were excluded.Tumor mutational burden was determined by the FoundationOne CDx assay,
open label
NA
P3/ two sided and one interim analysis. Repartition between coprimary end point and hierarchy with secondary endpoint.
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
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