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pembrolizumab alone (n=637) vs. Standard of Care (SoC) (n=637)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg alone every 3 weeks.
platinium based chemotherapy
investigator’s choice of carboplatin to achieve an area under the curve of 5–6 mg/mL per minplus paclitaxel 200 mg/m² (47.6%) or pemetrexed 500 mg/m² (49.0%) every 3 weeks.
No crossover from the chemotherapy group to pembrolizumab was allowed as part of the study.
mNSCLC - L1 - PDL1 positive
Patients without a sensitising EGFR mutation or ALK translocation were included
open label
213 sites in 32 countries
P3/ one sided and two interim analysis. Hierarchy between coprimary endpoints and secondary endpoint
IA2 results (stopped)/this trial meet its primary endpoint of OS in PDL1 >50, >20% and >1% but not its secondary endpoints PFS or ORR in each group
pembrolizumab alone (n=154) vs. Standard of Care (SoC) (n=151)
randomized controlled trial
Pembrolizumab
(200 mg) administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD
ICC platinum-based chemotherapies regimens
for 4 to 6 cycles (carboplatin plus pemetrexed (44.4%), cisplatin plus pemetrexed (23.8%), carboplatin plus gemcitabine (13.2%), cisplatin plus gemcitabine (7.3%), or carboplatin plus paclitaxel(11.3%))
Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of disease progression
mNSCLC - L1 - PDL1 positive
Patients were excluded if they had sensitizing EGFR mutations, ALK translocations
open label
142 sites in 16 countries
P3/ one sided and two interim analysis. The statistical test strategy foresees a repartition between PFS (2%) and ORR (0.5%) and a hierarchy with the PFS and the OS(0.0118% AI)
In patients with advanced NSCLC and PD-L1 expression on at least 50% of tumor cells,pembrolizumab was associated with significantly longer progression-free and overallsurvival and with fewer adverse events than was platinum-based chemotherapy
pembrolizumab alone (n=299) vs. Standard of Care (SoC) (n=300)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg alone every 3 weeks.
platinium based chemotherapy
investigator’s choice of carboplatin to achieve an area under the curve of 5–6 mg/mL per minplus paclitaxel 200 mg/m² or pemetrexed 500 mg/m² every 3 weeks. (no % for this sub-population)
No crossover from the chemotherapy group to pembrolizumab was allowed as part of the study.
mNSCLC - L1 - PDL1 positive
Patients without a sensitising EGFR mutation or ALK translocation were included
open label
213 sites in 32 countries
P3/ one sided and two interim analysis. Hierarchy between coprimary endpoints and secondary endpoint
IA2 results (stopped)/this trial meet its primary endpoint of OS in PDL1 >50, >20% and >1% but not its secondary endpoints PFS or ORR in each group
pembrolizumab alone (n=413) vs. Standard of Care (SoC) (n=405)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg alone every 3 weeks.
platinium based chemotherapy
investigator’s choice of carboplatin to achieve an area under the curve of 5–6 mg/mL per minplus paclitaxel 200 mg/m² or pemetrexed 500 mg/m² every 3 weeks. (no % for this sub-population)
No crossover from the chemotherapy group to pembrolizumab was allowed as part of the study.
mNSCLC - L1 - PDL1 positive
Patients without a sensitising EGFR mutation or ALK translocation were included
open label
213 sites in 32 countries
P3/ one sided and two interim analysis. Hierarchy between coprimary endpoints and secondary endpoint
IA2 results (stopped)/this trial meet its primary endpoint of OS in PDL1 >50, >20% and >1% but not its secondary endpoints PFS or ORR in each group
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