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)

Official Title

An Adaptive Phase III, Multicentre, 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

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-tumour 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.

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) assessed by Independent Review Committee (IRC)
  • Overall survival (OS)
Secondary Outcome:
  • Occurrences of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
  • Objective Response According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) Assessed by Independent Review Committee
  • Duration of Response Assessed from Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 Assessed by Independent Review Committee
  • Concentration of M7284 at the end of Infusion (Ceoi)
  • Concentration of M7284 at the end of the Dosing Interval (C trough)
  • Immunogenicity as measured by Anti-drug Antibodies Concentration

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society