Study 303 (SELECT): Study Schema
Patients with
DTC
(N = 392)
• IRR evidence of
progression
within previous
13 months
•
131
I-refractory
disease
• Measurable
disease
• Up to 1 prior
VEGF or
VEGFR-
targeted therapy
Placebo (n = 131)
24 mg daily PO
Lenvatinib (n = 261)
24 mg daily PO
Stratification
• Geographic
region
(Europe,
N. America,
Other)
• Prior VEGF/
VEGFR-
targeted
therapy
(0,1)
• Age
(≤ 65 years,
> 65 years)
Treatment until
disease progression
confirmed by IRR
(RECIST v1.1)
Lenvatinib
(Optional, open-label)
Randomization 2:1
DTC, differentiated thyroid cancer;
131
I, radioiodine; IRR, independent radiologic review, ORR, objective response rate;
OS, overall survival; PO, by mouth; RECIST, response evaluation criteria in solid tumors.
Primary endpoint
• PFS
Secondary endpoints
• ORR
• OS
• Safety
Schlumberger M, et al.
N Engl J Med
2015
