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atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (n=155) vs. bevacizumab plus carboplatin and paclitaxel (n=129)
randomized controlled trial
atezolizumab and bevacizumab, carboplatin plus paclitaxel (ABCP)
atezolizumab 1200 mg every 3 weeks bevacizumab at a dose of 15 mg/kg,paclitaxel at a dose of 200 mg/m2 (175 mg for Asian patients), and carboplatin at an area under the concentration−time curve of 6 mg/ml/min
bevacizumab plus carboplatin plus paclitaxel (BCP)
bevacizumab at a dose of 15 mg per kilogram of body weight,paclitaxel at a dose of 200 mg per square meter of body-surface area (175 mg per square meter for Asian patients), and carboplatin at an areaunder the concentration−time curve of 6 mg per milliliter per minute. for four or six 21-day cycles
Crossover from the control arm to either of the experimental arms will not be permitted
non squamous - mNSCLC - L1 - Wild Type (WT)
patients with wild type genotype (patients with EGFR or ALK genetic alterations were excluded, The Teff gene signature was defined as the expression of PD-L1, CXCL9, and IFN-γ messenger RNA
open label
240 sites in 26 countries
P3/ two sided and one interim analysis. Repartition between coprimary endoint (ABCP vs BCP) and hierarchical testing procedure with secondary endpoint and then ACP vs BCP results
The addition of atezolizumab to bevacizumab plus chemotherapy significantly improved progression-free survival and overall survival among patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression and EGFR or ALK genetic alteration status, among patient with wild type (WT) and only PFS among patients with WT Teff
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (n=356) vs. bevacizumab plus carboplatin and paclitaxel (n=336)
randomized controlled trial
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (ABCP)
atezolizumab 1200 mg every 3 weeks bevacizumab at a dose of 15 mg/kg,paclitaxel at a dose of 200 mg/m2 (175 mg for Asian patients), and carboplatin at an area under the concentration−time curve of 6 mg/ml/min
bevacizumab and caroplatin plus paclitaxel (BCP)
bevacizumab at a dose of 15 mg per kilogram of body weight,paclitaxel at a dose of 200 mg per square meter of body-surface area (175 mg per square meter for Asian patients), and carboplatin at an areaunder the concentration−time curve of 6 mg per milliliter per minute.
Crossover from the control arm to either of the experimental arms will not be permitted
non squamous - mNSCLC - L1 - Wild Type (WT)
patients with wild type genotype only (patients with EGFR or ALK genetic alterations were excluded)
open label
240 sites in 26 countries
P3/ two sided and one interim analysis. Repartition between coprimary endoint (ABCP vs BCP) and hierarchical testing procedure with secondary endpoint and then ACP vs BCP results
The addition of atezolizumab to bevacizumab plus chemotherapy significantly improved progression-free survival and overall survival among patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression and EGFR or ALK genetic alteration status, among patient with wild type (WT) and only PFS among patients with WT Teff
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 pemetrexed and platin (n=292) vs. pemetrexed plus platin (n=286)
randomized controlled trial
Atezolizumab (induction and maintenance) plus pemetrexed plus platine
Atezolizumab 1200 mg IV every 3 weeks plus carboplatin or cisplatin (Carboplatin: AUC 6 mg/mL/min IV q3w; Cisplatin: 75 mg/m2 IV q3w) plus pemetrexed (500 mg/m2 IV q3w) for 4 or 6 cyclesb for induction and permetrexed maintenance therapy
pemetrexed plus platine
carboplatin or cisplatin (Carboplatin: AUC 6 mg/mL/min IV q3w; Cisplatin: 75 mg/m2 IV q3w) plus pemetrexed (500 mg/m2 IV q3w) for 4 or 6 cyclesb for induction and permetrexed maintenance therapy
non squamous - mNSCLC - L1 - Wild Type (WT)
open-label
NA
P3
IMpower132 met its co-primary endpoint of investigator-assessed PFS in the ITT population but preliminary results on OS were not significant (IA)
pembrolizumab and pemetrexed plus platin (n=60) vs. pemetrexed plus platin (n=63)
randomized controlled trial
pembrolizumab with carboplatin plus pemetrexed
4 cycles of pembrolizumab 200 mg administered over 30 min, with carboplatin plus permetrexed, (pemetrexed 500 mg/m² and carboplatin AUC 5 mg/mL per min were given for 4 cycles followed by optional indefi nite pemetrexed maintenance) followed by pembrolizumab for 24 months,
carboplatin plus pemetrexed
carboplatin plus permetrexed, (pemetrexed 500 mg/m² and carboplatin AUC 5 mg/mL per min were given for 4 cycles followed by optional indefi nite pemetrexed maintenance)
Patients from control group could crossover to receive pembrolizumab monotherapy after a washout period of 21 days
non squamous - mNSCLC - L1 - Wild Type (WT)
eligibility critera stipulated the absence of targetable EGFR mutations or ALK translocations.
open label
26 medical centres in the USA and Taiwan
P2/one sided and no interim analysis, hierarchy with secondary endpoint PFS
Combination of pembrolizumab, carboplatin, and pemetrexed provides a significant and clinically relevant improvement in ORR and PFS compared with chemotherapy alone
pembrolizumab plus SoC (n=410) vs. placebo plus SoC (n=206)
randomized controlled trial
pembrolizumab plus pemetrexed plus platine
200 mg of pembrolizumab every 3 weeks for up to 35 cycles with four cycles of ICC : cisplatin (75 mg per square meter of bodysurface area) or carboplatin (area under the concentration–time curve, 5 mg per milliliter per minute) plus pemetrexed (500 mg per square meter), all administered intravenously every 3 weeks, followed by pemetrexed (500 mg per square meter) every 3 weeks
placebo plus pemetrexed plus platine
four cycles of ICC : cisplatin (75 mg per square meter of bodysurface area) or carboplatin (area under the concentration–time curve, 5 mg per milliliter per minute) plus pemetrexed (500 mg per square meter), all administered intravenously every 3 weeks, followed by pemetrexed (500 mg per square meter) every 3 weeks
placebo-combination group were eligible to cross over to receive pembrolizumab monotherapy.
non squamous - mNSCLC - L1 - Wild Type (WT)
patients with sensitizing EGFR or ALK mutations were excluded
double-blind
126 sites in 16 countries
P3/ one sided and two interim analysis. Repartition, reallocation between coprimary endpoint and hirarchy with secondary endpoint ORR
AI1 stopped/ addition of pembrolizumab to SOC chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone. ORR was also significantly higher in pembrolizumab group.
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