NCT03088540

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 712 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

There is option to join genomics sub-study.

Conditions

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

Interventions

Type	Name	Description
DRUG	Pemetrexed	Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
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.

Timeline

• Start date: 2017-05-29
• Primary completion: 2025-04-18
• Completion: 2025-04-18
• First posted: 2017-03-23
• Last updated: 2026-02-23

Locations

192 sites across 24 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

Regulatory

• FDA-regulated drug study