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Phase I/II alectinib + bevacizumab in
ALK
+ NSCLC
NCT02521051
Dose de-escalation
(3+3 scheme)
Phase I
Alectinib 450
‒
600mg BID
+
bevacizumab
7.5mg/kg or 15mg/kg q3w
•
Stage IIIB/IV NSCLC
•
Non-squamous histology
•
ALK
+ disease (ALK rearrangement using FISH, IHC, or NGS)
•
ECOG PS 0–2
•
Phase II portion only: stable symptomatic or asymptomatic brain
mets that are untreated or progressive after previous local therapy
Phase I, n=6
–
12; phase II, n=32
Phase II
Alectinib RP2D
+
bevacizumab RP2D q3w
Primary endpoints
•
Phase I: RP2D
•
Phase II: safety, tolerability
Secondary endpoints
•
Phase I: safety, tolerability, DLT and PK
•
Phase II: CNS ORR/DCR/PFS, ORR, DCR, PFS, PK, PROs, resistance
mechanisms (optional biopsies)
¿Qué más…. nuevas combinaciones?