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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)
atezolizumab plus carboplatin plus nab-paclitaxel (n=451) vs. carboplatin plus nab-paclitaxel (n=228)
randomized controlled trial
atezolizumab (ACnP) plus carboplatine plus nab-paclitaxel
atezolizumab (1200 mg intravenously every 3 weeks)
carboplatine plus nab-paclitaxel
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 - Wild Type (WT)
PDL1 : VENTANA PD-L1 (SP142) Assay (Ventana Medical Systems, Tucson, AZ, USA), 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)
atezolizumab plus carboplatin plus nab-paclitaxel (n=343) vs. carboplatin plus nab-paclitaxel (n=340)
randomized controlled trial
atezolizumab plus carboplatine plus nab-paclitaxel(ACnP)
Atezolizumab was administered at 1200 mg intravenously plus carboplatin at an area under the concentration-time curve of 6 mg/mL/min IV (day 1), nab-paclitaxel at 100 mg/m2 IV (days 1, 8, and 15).
carboplatine plus nab-paclitaxel (CnP)
carboplatin at an area under the concentration-time curve of 6 mg/mL/min IV (day 1), nab-paclitaxel at 100 mg/m2 IV (days 1, 8, and 15).
Crossover to atezolizumab was not allowed
squamous - mNSCLC - L1 - all population
Patients known to have EGFR mutations or ALK fusion oncogene were eligible
open label
317 study sites across 26 countries
P3/ two sided and two interim analysis. Alpha split between coprimary endpoint (ACnP) and hierarchy with OS/PFS (ACP)
Adding atezolizumab to platinum-based chemotherapy significantly improved PFS in patients with first-line squamous NSCLC; OS was similar between arms.
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