click on circles to display study description...

CheckMate 9LA, 2021 NCT03215706

nivolumab plus ipilimumab plus SoC (n=361) vs. Standard of Care (SoC) (n=358)

randomized controlled trial

Studied treatment

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)

Control treatment

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;

Patients

mNSCLC - L1 - all population

Exclusion criteria included known EGFR mutations and ALK translocations that were sensitive to targeted therapy

Method

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

Remark

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.