ARCTIC (D ; study A ; PDL1>25% EXPLORATORY), 2020 NCT02352948
durvalumab alone (n=62) vs. Standard of Care (SoC) (n=64)
randomized controlled trial
durvalumab
durvalumab (10 mg/kg intravenously (i.v.) q2w for up to 12 months)
standard of care : erlotinib, gemcitabine or vinorelbine
1 of 3 SoC regimens: erlotinib (150 mg once a day by oral administration); gemcitabine (1000 mg/m2 i.v. over 30 minutes onDays 1, 8, and 15 of a 28-day cycle); or vinorelbine (30mg/m2 i.v. on Days 1, 8, 15, and 22 of a 28-day cycle). Gemcitabine: 34.4% vinorelbine: 32.8% and erlotinib:31.3%.
Dose reductions are not permitted for durvalumab or tremelimuab (mono and combi)
mNSCLC - L2 - PDL1 positive
patients with >25% of tumor cells (TCs) expressing programmed cell death ligand-1 (PD-L1). Patients who do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements
open label
205 study centers in 26 countries
P3/two sided and no interim anaysis. Repartition between primary endpoint (0.04 OS and 0.01 PFS) for study B only
this study did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS). the results of this study (A) were exploratory