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Primary endpoint
•
PFS by independent review
Secondary endpoints
•
OS
•
ORR
•
DCR
•
Response duration
•
QoL
•
Safety
1:1
Stage IIIB/IV or recurrent NSCLC
Non-squamous histology
EGFR
Mut+
–
exon 19 deletion / L858R*
No prior treatment
ECOG PS 0–1
(n=150)
R
Stratified by: gender, stage,
smoking status,
EGFR
Mut type
PD
PD
Avastin 15mg/kg i.v q3w + Tarceva 150mg/day
(A+T)
Tarceva 150mg/day (T)
Kato, et al. ASCO 2014
Exploratory endpoints
•
Biomarkers
*T790M excluded
EGFR
mutation assays performed at investigational site
using:
PNA LNA PCR Clamp PCR-Invader, Cycleave or ‘Other’
methods