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)

Completed · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03631706

Run by

EMD Serono Research & Development Institute, Inc.

People needed

304

Starts

2018-10-01

Expected to finish

2024-06-25

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of advanced NSCLC
• Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
• Have measurable disease based on RECIST 1.1
• Have a life expectancy of at least 3 months
• Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
• PD-L1 high status as determined by central testing
• Other protocol defined inclusion criteria could apply

You may not qualify if…

• Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
• Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
• Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
• Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
• Other protocol defined exclusion criteria could apply

Where it is running

• Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic — Los Angeles, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Kaiser Permanente - Harbor City — San Diego, California, United States
• Sansum Clinic - Santa Barbara — Santa Barbara, California, United States
• Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada — Colorado Springs, Colorado, United States
• Eastern Connecticut Hematology/Oncology Assoc. — Norwich, Connecticut, United States
• Cancer Specialists, LLC - Department of Clinical Research — Jacksonville, Florida, United States
• Woodlands Medical Specialists — Pensacola, Florida, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Decatur Memorial Hospital - Clinical Research — Decatur, Illinois, United States
• Baptist Health Lexington Oncology Associates — Lexington, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account — Kansas City, Missouri, United States
• Southeast Nebraska Cancer Center — Lincoln, Nebraska, United States
• The Valley Hospital - Luckow Pavilion — Paramus, New Jersey, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UPMC Cancer Center — Pittsburgh, Pennsylvania, United States
• SCRI - Tennessee Oncology — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Oncology - Bedford — Bedford, Texas, United States
• Texas Oncology, P.A. - Sugarland — Sugar Land, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Oncology Specialties, PC; Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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