ARCTIC (DT ; study B ; PDL1<25%), 2020 NCT02352948
durvalumab plus tremelimumab (n=174) vs. Standard of Care (SoC) (n=118)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab (10 mg/kg intravenously (i.v.) q2w for up to 12 months)plus tremelimumab (12 weeks durvalumab 20 mg/kg plus tremelimumab 1 mg/kg q4w then 34 weeks durvalumab 10 mg/kg q2w)
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. 69.2% (gemcitabine:41.5% vinorelbine: 22.0%), erlotinib: 29.7%
Dose reductions are not permitted for durvalumab or tremelimuab (mono and combi)
mNSCLC - L2 - PDL1 negative
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).