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

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

Conditions

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

Interventions

DRUG

Paclitaxel

Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

DRUG

Gemcitabine

Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

DRUG

Cisplatin

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

DRUG

Carboplatin

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

DRUG

cemiplimab

Patients will be administered cemiplimab as per protocol.

DRUG

Pemetrexed

Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

Sponsors & Collaborators

• Sanofi

  collaborator INDUSTRY

• Regeneron Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-29

Primary Completion

2025-04-18

Completion

2025-04-18

FDA Drug

Yes

Countries

• Australia
• Belarus
• Brazil
• Bulgaria
• Chile
• China
• Colombia
• Czechia
• Georgia
• Greece
• Hungary
• Jordan
• Lebanon
• Malaysia
• Mexico
• Philippines
• Poland
• Romania
• Russia
• Spain
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine

Study Locations