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pembrolizumab (10mg/kg) (n=346) vs. docetaxel (n=343)
randomized controlled trial
pembrolizumab 10 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. (5 years results pooled 10 and 2mg)
pembrolizumab (10mg/kg) (n=151) vs. docetaxel (n=152)
randomized controlled trial
pembrolizumab 10 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefi t-to-risk profi le in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer (5 years results pooled 10 and 2mg)
pembrolizumab (2mg/kg) (n=139) vs. docetaxel (n=152)
randomized controlled trial
pembrolizumab 2 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefi t-to-risk profi le in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer
pembrolizumab (2mg/kg) (n=344) vs. docetaxel (n=343)
randomized controlled trial
pembrolizumab 2 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis, repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefi t-to-risk profi le in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer
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