OncRef

Clinical Trial: NCT03088540

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Regeneron Pharmaceuticals
Information Provided By:Regeneron Pharmaceuticals
Last Update Posted:2026-06-25

Study Overview

Brief Summary

The primary objectives of the study are:

  • To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells
  • To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells

The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies

Official Title

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

Conditions

Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer

Intervention / Treatment

  • Drug: Pemetrexed
  • Drug: Paclitaxel
  • Drug: Gemcitabine
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: cemiplimab

Other Study ID Numbers

  • R2810-ONC-1624
  • 2016-004407-31
  • 2024-515052-20-00
  • 2016

Start Date (Actual)

2017-05-29

Primary Completion Date (Actual)

2025-04-18

Study Completion Date (Actual)

2025-04-18

Enrollment (Actual)

712

Study Type

Interventional

Phase

Phase 3