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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
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