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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.
avelumab alone (n=396) vs. docetaxel (n=396)
randomized controlled trial
avelumab
10 mg/kg avelumab intravenously over 1 h once every 2 weeks, Dose modification of avelumab was not permitted.
docetaxel
75 mg/m docetaxel intravenously over 1 h every 3 weeks
No crossover to avelumab was permitted.
mNSCLC - L2 - all population
Patients were not eligible if they had non-squamous cell NSCLC harbouring an EGFR or ALK mutation
open label
173 hospitals and cancer treatment centres in 31 countries
P3/ one sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
Compared with docetaxel, avelumab did not improve overall survival in patients with platinum-treated PD-L1-positive NSCLC nor in ITT population, but had a favourable safety profile
nivolumab alone (n=338) vs. docetaxel (n=166)
randomized controlled trial
nivolumab
nivolumab 3 mg/kg every 2 weeks
docetaxel
docetaxel 75 mg/m2 every 3 weeks
mNSCLC - L2 - all population
patients with EGFR-mutation–positive tumors or knownALK receptor tyrosine kinase (ALK) translocation–positive tumors were excluded.
open label
32 hospitals and cancer/medical centers in China, Russia, and Singapore
P3/ two sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
In this predominantly Chinese population with previously treated advanced NSCLC, nivolumab improved OS (ORR and PFS as secondary endpoints) versus docetaxel.
Tislelizumab (n=-9) vs. docetaxel (n=-9)
randomized controlled trial
Tislelizumab
100 mg per vial, 200mg intravenous (IV), Q3W
Docetaxel
75 mg/m2 IV Q3W
mNSCLC - L2 - all population
open label
P3
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