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KEYNOTE-024 Study Design (NCT02142738
)
a
Optional pemetrexed maintenance therapy for nonsquamous disease.
b
Permitted for nonsquamous disease only.
c
Prior to the DMC recommendation and amendment 6, which permitted those in the chemotherapy arm to be offered pembrolizumab (ba
sed on interim analysis 2
data), patients were eligible for crossover when PD was confirmed by blinded, independent central radiology review.
Key Eligibility Criteria
•
Untreated stage IV NSCLC
•
PD-L1 TPS ≥50%
•
ECOG PS 0–1
•
No activating
EGFR
mutation or
ALK
translocation
•
No untreated brain metastases
•
No active autoimmune disease
requiring systemic therapy
Pembrolizumab
200 mg IV Q3W
(2 years)
R (1:1)
N =
305
Pembrolizumab
200 mg Q3W
for 2 years
Platinum-Doublet
Chemotherapy
a
(4–6 cycles)
•
Pemetrexed + carboplatin
b
•
Pemetrexed + cisplatin
b
•
Paclitaxel + carboplatin
•
Gemcitabine + carboplatin
•
Gemcitabine + cisplatin
End Points
Primary:
PFS (RECIST v1.1,
blinded
independent central review)
Key secondary:
OS
Secondary:
ORR, safety
Exploratory:
DOR
PD
c