M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Official Title

A Multicentre, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer

Summary:

The main purpose of this study is to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) Assessed by Independent Review Committee (IRC)
Secondary Outcome:
  • Occurrence of Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs
  • Overall Survival
  • Changes from Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)
  • Programmed death-ligand 1 (PD-L1) Expression in Tumours Assessed with Immunohistochemistry (IHC) and Association with Efficacy
  • Objective Response According to RECIST 1.1 Assessed by IRC
  • Duration of Response According to RECIST 1.1
  • Immunogenicity of M7824 as Measured by Antidrug Antibody (ADA) Assays
  • Concentration Immediately Before Next Dosing (Ctrough)
  • Concentration Immediately at End of Infusion (Ceoi)
  • Changes from Baseline in High-resolution Computed Tomography (HRCT)
  • Changes from Baseline in Forced Expiratory Volume in one Second (FEV1)
  • Changes from Baseline in Forced Vital Capacity (FVC)
  • Changes from Baseline in 6-minutes Walking Test

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