KEYNOTE-021 phase 2, 2016 trial summary

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

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NCT02039674    Lancet Oncol 2016;17:1497-1508  
1st line nonsquamous NSCLC



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
PD-L1 expression all



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

phase 1/2



EndpointX1N1X0N0TE95% CI0,22,01,0

Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol 2016;17:1497-1508     [PMID: 27745820]   link to pdf   add to Mendeley  

Links

ESMO

ClinicalTrial.gov record NCT02039674



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