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KEYNOTE-021, 2016 NCT02039674

pembrolizumab and pemetrexed plus platin (n=60) vs. pemetrexed plus platin (n=63)

randomized controlled trial

Studied treatment

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,

Control treatment

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

Patients

non squamous - mNSCLC - L1 - Wild Type (WT)

eligibility critera stipulated the absence of targetable EGFR mutations or ALK translocations.

Method

open label

26 medical centres in the USA and Taiwan

P2/one sided and no interim analysis, hierarchy with secondary endpoint PFS

Remark

Combination of pembrolizumab, carboplatin, and pemetrexed provides a significant and clinically relevant improvement in ORR and PFS compared with chemotherapy alone