Previous Page  8 / 54 Next Page
Information
Show Menu
Previous Page 8 / 54 Next Page
Page Background

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