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

NCT03409614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 789

Last updated 2026-05-18

Study results available
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Summary

The primary objectives of this study are:

Part 1: To compare the overall survival (OS) 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) with tumors expressing PD-L1 in \<50% of tumor cells.

Part 2: To compare the OS 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 objectives are:

Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells.

Part 2: To compare the PFS and 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.

Conditions

Interventions

DRUG

REGN2810

REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2

DRUG

REGN2810/chemo/ipi

REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1

OTHER

Chemotherapy

Platinum-based doublet chemotherapy Part 1

DRUG

Placebo

Matching placebo Part 2

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2025-02-27
Completion
2025-02-27
FDA Drug
Yes

Countries

  • United States
  • Austria
  • China
  • France
  • Georgia
  • Greece
  • Ireland
  • Italy
  • Lithuania
  • Malaysia
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409614 on ClinicalTrials.gov