CompletedPhase 3NCT03631706

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)

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.

Checked against the public recordLast updated Apr 8, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations119
SponsorEMD Serono Research & Development Institute, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
EMD Serono Research & Development Institute, Inc.
Interventions being studied
Drug: M7824; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Oncology Specialties, PC; Clearview Cancer InstituteHuntsville, Alabama
  • Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (ClinicLos Angeles, California
  • UC Irvine Medical CenterOrange, California
  • Kaiser Permanente - Harbor CitySan Diego, California
  • Sansum Clinic - Santa BarbaraSanta Barbara, California
  • Rocky Mountain Cancer Centers - Colorado Springs, N. NevadaColorado Springs, Colorado
  • Eastern Connecticut Hematology/Oncology Assoc.Norwich, Connecticut
  • Cancer Specialists, LLC - Department of Clinical ResearchJacksonville, Florida
  • Woodlands Medical SpecialistsPensacola, Florida
  • The University of Chicago Medical CenterChicago, Illinois
  • Decatur Memorial Hospital - Clinical ResearchDecatur, Illinois
  • Baptist Health Lexington Oncology AssociatesLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 8, 2025. Always confirm current availability with the study team.

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