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atezolizumab alone (n=166) vs. Standard of Care (SoC) (n=162)
randomized controlled trial
atezolizumab
Atezolizumab 1200 mg once every 3 weeks.
platinium chemotherapy
platinum-based chemotherapy (4 or 6 cycles) once every 3 weeks. (either cisplatin (75 mg per square meter of body-surface area) or carboplatin (area under the concentration−time curve [AUC], 6) in addition to pemetrexed (500 mg per square meter) (72.5%) or gemcitabine ( 1000 to 1250 mg per square meter) intravenously) (27.4%)
No crossover to the atezolizumab group was permitted.
mNSCLC - L1 - PDL1 positive
Initially, patients with a knownsensitizing EGFR mutation or ALK translocation were eligible provided they had received previous targeted therapy. The protocol was subsequently amended to exclude these patients from the analysis (18 patients) because emerging data suggested that they may not benefit from immune-checkpoint inhibitor monotherapy
open label
144 centers in 19 countries
P3/two sided with one interim analysis. Hierachical testing procedure OS (PDL1 TC3 then TC2/3 then TC 1/2/3)
IA1 stopped: Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type
atezolizumab alone (n=277) vs. Standard of Care (SoC) (n=277)
randomized controlled trial
atezolizumab
Atezolizumab 1200 mg once every 3 weeks.
platinium chemotherapy
platinum-based chemotherapy (4 or 6 cycles) once every 3 weeks. (either cisplatin (75 mg per square meter of body-surface area) or carboplatin (area under the concentration−time curve [AUC], 6) in addition to pemetrexed (500 mg per square meter) (69.5%) or gemcitabine ( 1000 to 1250 mg per square meter) (30.5%) intravenously
No crossover to the atezolizumab group was permitted.
mNSCLC - L1 - PDL1 positive
Initially, patients with a knownsensitizing EGFR mutation or ALK translocation were eligible provided they had received previous targeted therapy. The protocol was subsequently amended to exclude these patients from the analysis (18 patients) because emerging data suggested that they may not benefit from immune-checkpoint inhibitor monotherapy
open label
144 centers in 19 countries
P3/two sided with one interim analysis. Hierachical testing procedure OS (PDL1 TC3 then TC2/3 then TC 1/2/3)
IA1 stopped: Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type
atezolizumab alone (n=107) vs. Standard of Care (SoC) (n=98)
randomized controlled trial
atezolizumab
Atezolizumab 1200 mg once every 3 weeks.
platinum chemotherapy
platinum-based chemotherapy (4 or 6 cycles) once every 3 weeks. (either cisplatin (75 mg per square meter of body-surface area) or carboplatin (area under the concentration−time curve [AUC], 6) in addition to pemetrexed (500 mg per square meter) (75.6%) or gemcitabine ( 1000 to 1250 mg per square meter) (24.4%) intravenously)
No crossover to the atezolizumab group was permitted.
mNSCLC - L1 - PDL1 positive
Initially, patients with a knownsensitizing EGFR mutation or ALK translocation were eligible provided they had received previous targeted therapy. The protocol was subsequently amended to exclude these patients from the analysis (18 patients) because emerging data suggested that they may not benefit from immune-checkpoint inhibitor monotherapy
open label
144 centers in 19 countries
P3/two sided with one interim analysis. Hierachical testing procedure OS (PDL1 TC3 then TC2/3 then TC 1/2/3)
IA1 stopped: Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression (TC3 or IC3), regardless of histologic type
atezolizumab alone (n=613) vs. docetaxel (n=612)
randomized controlled trial
atelozumab
Atezolizumab intravenous 1200 mg fixed dose every 3 weeks
docetaxel
docetaxel at 75 mg/m² every 3 weeks
No crossover to atezolizumab was allowed
mNSCLC - L2 - all population
Patients with EGFR mutations or an ALK fusion oncogene were additionally required to have received previous tyrosine kinase inhibitor therapy. Results from ITT 1225
open label
194 academic or community oncology centres in 31 countries
P3/ two sided no interim analysis planned. A splitting between the ITT population [a=3%] and the PDL1 TC1/2/3 or IC1/2/3 population [a=2%]) and reallocation 5% to OS SG TC2/3 and then TC3 was planned. An initial analysis with 850 patients was planned, but an amendement modified the population to 1225 before the analysis. Here we report the final results in ITT1225
Atezolizumab treatment significantly improve overall survival versus docetaxel in previously treated non-small-cell lung cancer, regardless of PD-L1 expression or histology
atezolizumab alone (n=144) vs. docetaxel (n=143)
randomized controlled trial
atezolizumab
atezolizumab 1200 mg once every 3 weeks
docetaxel
docetaxel 75 mg/m(2) once every 3 weeks
No docetaxel-to-atezolizumab crossover was allowed.
mNSCLC - L2 - all population
no specific information about EGFR or ALK status at inclusion
open label
61 academic medical centres and community oncology practices across 13 countries in Europe and North
P2/ two sided and three interim analysis. Hierarchical testing procedure with OS in PDL1 subgroups
Atezolizumab significantly improved survival compared with docetaxel in patients with previously treated NSCLC.
atezolizumab alone (n=347) vs. docetaxel (n=337)
randomized controlled trial
atelozumab
Atezolizumab intravenous 1200 mg fixed dose every 3 weeks
docetaxel
docetaxel at 75 mg/m² every 3 weeks
No crossover to atezolizumab was allowed
mNSCLC - L2 - PDL1 positive
Patients with EGFR mutations or an ALK fusion oncogene were additionally required to have received previous tyrosine kinase inhibitor therapy.
open label
194 academic or community oncology centres in 31 countries
P3/ two sided no interim analysis planned. A splitting between the ITT population [a=3%] and the PDL1 TC1/2/3 or IC1/2/3 population [a=2%]) and reallocation 5% to OS SG TC2/3 and then TC3 was planned. an initial analysis with 850 patients was planned, but an amendement modified the population to 1225 before the analysis
Atezolizumab treatment significantly improve overall survival versus docetaxel in previously treated non-small-cell lung cancer, regardless of PD-L1 expression or histology
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (n=400) vs. bevacizumab plus carboplatin and paclitaxel (n=400)
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 - all population
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 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 paclitaxel (n=402) vs. bevacizumab plus carboplatin and paclitaxel (n=400)
randomized controlled trial
atezolizumab plus carboplatin plus paclitaxel (ACP)
atezolizumab 1200 mg every 3 weeks,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 - all population
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 chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer resulted in significantly longer overall survival and progression-free survival than chemotherapy alone.
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)
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.
atezolizumab plus carboplatin plus paclitaxel (n=338) vs. nab-paclitaxel (n=340)
randomized controlled trial
atezolizumab plus carboplatine plus paclitaxel (ACP)
Atezolizumab was administered at 1200 mg intravenously and paclitaxel at 200 mg/m2 IV (175 mg/m2 for Asian race/ethnicity; day 1)
carboplatine plus nabpaclitaxel (CnP)
carboplatin at an area under the concentration-time curve of 6 mg/mL/min IV (day 1), nab-paclitaxel at 100 or 200 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 the arms.No efficay results for this arm because of hierarchy
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