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Study Design: Trial Diagram: KEYNOTE-189

Patients:

Metastatic non-

squamous NSCLC

First line metastatic

treatment

Measurable disease

ECOG PS 0-1

Tissue for

biomarker available

EGFR wild type

EML4/ALK or ROS-1

fusion negative

No known CNS

metastases

Stratify:

PDL1 prop score:

≥1%, <1%

Smoking status

cisplatin vs

carboplatin

R

A

N

D

O

M

I

Z

A

T

I

O

N

2:1

N=570

Carboplatin/Cisplatin

Pemetrexed

Pembrolizumab

200 mg Q3W

X4 cycles

Carboplatin/Cisplatin

Pemetrexed

+Saline

X4 cycles

Pemetrexed

Pembrolizumab

Pemetrexed

+Saline

PD

Pembrolizumab

PD

Primary Endpoint: PFS – target HR 0.7

Secondary Endpoints: OS, ORR, AE

Exploratory Endpoints: QoL

Off

Study