NCT03631706

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	M7824	Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
DRUG	Pembrolizumab	Pembrolizumab: Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-06-07
• Completion: 2024-06-25
• First posted: 2018-08-15
• Last updated: 2025-04-08
• Results posted: 2022-06-29

Locations

119 sites across 18 countries: United States, Argentina, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study