atezolizumab plus carboplatin plus nab-paclitaxel (n=483) vs. atezolizumab plus carboplatin plus nab-paclitaxel (n=240)
randomized controlled trial
atezolizumab plus carboplatin plus nab-paclitaxel (ACnp)
atezolizumab (1200 mg intravenously every 3 weeks) plus carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m]
carboplatine plus nab-paclitaxel (CnP)
carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m]
Crossover to receive atezolizumab at disease progression was permitted only for patients in the chemotherapy group enrolled before June 15, 2016.
non squamous - mNSCLC - L1 - all population
PDL1 : VENTANA PD-L1 (SP142) Assay (Ventana Medical Systems, Tucson, AZ, USA), randomisation). Patients with unknown EGFR or ALK status were required to have had locally or centrally assessed testing at screening.
open label
131 academic medical centres and community oncology practices in North America, Europe and Israel
P3/ two sided one interim analysis. Alpha split between coprimary endpoints, reallocation and hierarchy testing procedure with secondary endpoints
this study showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer (ITT) and no ALK or EGFR mutations (WT)