ASCEND-5: phase III study of ceritinib vs chemotherapy in crizotinib-
and chemo-pretreated patients with
ALK+
NSCLC
Scagliotti, et al. ESMO 2016
•
Stage IIIB/IV NSCLC
•
ALK
+ disease according to FISH
•
Previous treatment with crizotinib
(platinum doublet)
•
≥1 measurable lesion as defined by
RECIST 1.1
(n=236)
Ceritinib
750mg/day
Pemetrexed 500mg/m
2
i.v. q3w or docetaxel
75mg/m
2
i.v. q3w
1
2
PFS
Endpoints
ORR, DoR, DCR, time to response, OS,
safety, PK, QoL
R
