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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
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 and pemetrexed plus platin (n=60) vs. pemetrexed plus platin (n=63)
randomized controlled trial
pembrolizumab with carboplatin plus pemetrexed
4 cycles of pembrolizumab 200 mg administered over 30 min, with carboplatin plus permetrexed, (pemetrexed 500 mg/m² and carboplatin AUC 5 mg/mL per min were given for 4 cycles followed by optional indefi nite pemetrexed maintenance) followed by pembrolizumab for 24 months,
carboplatin plus pemetrexed
carboplatin plus permetrexed, (pemetrexed 500 mg/m² and carboplatin AUC 5 mg/mL per min were given for 4 cycles followed by optional indefi nite pemetrexed maintenance)
Patients from control group could crossover to receive pembrolizumab monotherapy after a washout period of 21 days
non squamous - mNSCLC - L1 - Wild Type (WT)
eligibility critera stipulated the absence of targetable EGFR mutations or ALK translocations.
open label
26 medical centres in the USA and Taiwan
P2/one sided and no interim analysis, hierarchy with secondary endpoint PFS
Combination of pembrolizumab, carboplatin, and pemetrexed provides a significant and clinically relevant improvement in ORR and PFS compared with chemotherapy alone
pembrolizumab plus SoC (n=410) vs. placebo plus SoC (n=206)
randomized controlled trial
pembrolizumab plus pemetrexed plus platine
200 mg of pembrolizumab every 3 weeks for up to 35 cycles with four cycles of ICC : cisplatin (75 mg per square meter of bodysurface area) or carboplatin (area under the concentration–time curve, 5 mg per milliliter per minute) plus pemetrexed (500 mg per square meter), all administered intravenously every 3 weeks, followed by pemetrexed (500 mg per square meter) every 3 weeks
placebo plus pemetrexed plus platine
four cycles of ICC : cisplatin (75 mg per square meter of bodysurface area) or carboplatin (area under the concentration–time curve, 5 mg per milliliter per minute) plus pemetrexed (500 mg per square meter), all administered intravenously every 3 weeks, followed by pemetrexed (500 mg per square meter) every 3 weeks
placebo-combination group were eligible to cross over to receive pembrolizumab monotherapy.
non squamous - mNSCLC - L1 - Wild Type (WT)
patients with sensitizing EGFR or ALK mutations were excluded
double-blind
126 sites in 16 countries
P3/ one sided and two interim analysis. Repartition, reallocation between coprimary endpoint and hirarchy with secondary endpoint ORR
AI1 stopped/ addition of pembrolizumab to SOC chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone. ORR was also significantly higher in pembrolizumab group.
pembrolizumab plus SoC (n=278) vs. placebo plus SoC (n=281)
randomized controlled trial
pembrolizumab plus platine and (nab)paclitaxel
200 mg of pembrolizumab on day 1 for up to 35 cycles in 3-week cycles and for the first 4 cycles, carboplatin (at a dose calculated to produce an area under the concentration–time curve of 6 mg per milliliter per minute)on day 1 and either paclitaxel (200 mg per square meter of body-surface area) on day 1 or nab-paclitaxel (100 mg per square meter) on days 1, 8, and 15
placebo plus platine and (nab)paclitaxel
placebo on day 1 for up to 35 cycles in 3-week cycles and for the first 4 cycles, carboplatin (at a dose calculated to produce an area under the concentration–time curve of 6 mg per milliliter per minute)on day 1 and either paclitaxel (200 mg per square meter of body-surface area) on day 1 or nab-paclitaxel (100 mg per square meter) on days 1, 8, and 15
patients with progression will have the opportunity to crossover to receive open-label pembrolizumab monotherapy
squamous - mNSCLC - L1 - all population
no information about EGFR or ALK status
open-label
137 sites in 17 countries
P3/ one sided and three interim analysis. Repartition and reallocation between coprimary endpoint PFS OS and then ORR
AI2 (stopped) In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab-paclitaxelresulted in significantly longer overall survival and progression-free survival than chemotherapyalone
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