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

A Phase II, Multicentre, Randomized, Open-Label, Controlled Study of M7824 Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

Summary:

The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumour expression.

Trial Description

Primary Outcome:

  • Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) as Evaluated by Independent Review Committee
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) as Evaluated by Independent Review Committee
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
  • Overall Survival (OS) Time
  • Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) as Evaluated by Investigator
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) as Evaluated by Investigator
  • 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