AURA 3, 2017 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of osimertinib versus platinum-based therapy plus pemetrexed in patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed after 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy.

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NCT02151981    N Engl J Med 2017 Feb 16;376:629-640  



Studied treatment oral osimertinib (at a dose of 80 mg once daily)
Control treatment intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles
Concomittant treatmentmaintenance pemetrexed was allowed



Patients patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed after 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy.
Group sizes-9 / -9
patients



Blindness Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Design
EGFR mutation EGFR T790M mutation



EndpointX1N1X0N0TE95% CI ORR - -9 - -9 no data OS - -9 - -9 no data PFS - -9 - -9 0,30[0,22; 0,40]0,22,01,0

Mok TS, Wu Y-L, Ahn M-J, Garassino MC, Kim HR, Ramalingam SS, Shepherd FA, He Y, Akamatsu H, Theelen WS, Lee CK, Sebastian M, Templeton A, Mann H, Marotti M, Ghiorghiu S, Papadimitrakopoulou VA Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med 2017 Feb 16;376:629-640     [PMID: 27959700]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT02151981



Registering number NCT02151981 (see trial on clinicaltrials.gov)
Code Name