West Cancer Center

LUNG: Metastatic: NSCLC: PD-L1 high; 1st line; "KEYNOTE-024"

A randomized phase III trial of MK-3475 versus platinum based chemotherapy in 1L subjects with PD-L1 strong metastatic non-small cell lung cancer

Title

Merck MK-3475-024

Study Title

A randomized phase III trial of MK-3475 versus platinum based chemotherapy in 1L subjects with PD-L1 strong metastatic non-small cell lung cancer

Site Link

NCT02142738

Malignancy

Lung Cancer (b), NSCLC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

Pembrolizumab (MK-3475)

Drug Class

PD-1 inhibitor

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp.

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02142738

Key Eligibility Criteria Details

Stage IV, EGFR wt, ALK negative
PD-L1 strong expressing tumor
Available tumor biopsy of metastatic disease
ECOG PS 0-1
No prior metastatic therapy
No active autoimmune disease
No history of pneumonitis requiring steroids

Objective

Primary- PFS; Secondary; OS, ORR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Any histology (squamous, non-squamous)PD-L1 strong�expressingALK negative (-)EGFR wild type (wt)

Dosing Frequency

Pembrolizumab 200mg IV q21 days

Control Agents

Carbo(Cis)/taxol, carbo(cis)/alimta, carbo(cis)/gemzar

Study Protocol

Randomized

Yes