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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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