Last updated on August 2019

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer


Brief description of study

The primary objectives of this study are:

Part 1: To evaluate the objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) in the subgroup of patients whose tumors express programmed cell death ligand-1 (PD-L1) in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells.

Part 2: To compare the overall survival (OS) and progression-free survival (PFS) of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

The key secondary objective is:

Part 2: To compare the ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

Clinical Study Identifier: NCT03409614

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