click on circles to display study description...
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.
powered by vis.js Network