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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
avelumab alone (n=264) vs. docetaxel (n=265)
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 - PDL1 positive
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
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