KEYNOTE-021, trial summary

A randomised clinical trial investigating the effect of pembrolizumab + CT versus CT in patients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung cancer

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NCT02039674    
1st line



Studied treatment 24 months treatment with pembrolizumab (200mg every three weeks)+ CT
Control treatment four cycles of carboplatin and pemetrexed (500 mg/m2 every three weeks)



Patients patients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung cancer
Group sizes60 / 63



Blindness open design Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint ORR Design Parallel groups
type of cancer

phase 1/2



EndpointX1N1X0N0TE95% CI ORR - 60 - 63 no data overall survival - 60 - 63 no data grade 3–5 drug-related AEs - 60 - 63 no data PFS - 60 - 63 0,53[0,31; 0,91]0,22,01,0

Links

ESMO

ClinicalTrial.gov record NCT02039674



Registering number NCT02039674 (see trial on clinicaltrials.gov)
Code Name