This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.

Official Title

A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)

Summary:

Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumour microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.

Trial Description

Primary Outcome:

  • Major Pathological Response (MPR) rate based on Central review
Secondary Outcome:
  • Antidrug antibodies (ADA) of canakinumab
  • Antidrug antibodies (ADA) of pembrolizumab
  • Overall response rate (ORR) per investigator assessment using RECIST v1.1
  • Serum canakinumab concentration
  • Serum pembrolizumab concentration
  • Surgical feasibility rate
  • MPR based on central review
  • MPR based on local review
  • Difference in MPR rate based on central review
  • MPR rate based on the levels of biomarkers

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