Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design

Future Oncol. 2021 Apr;17(12):1459-1472. doi: 10.2217/fon-2020-1098. Epub 2021 Mar 2.


Canakinumab is a human IgGκ monoclonal antibody, with high affinity and specificity for IL-1β. The Canakinumab Anti-Inflammatory Thrombosis Outcome Study (CANTOS) trial, evaluating canakinumab for cardiovascular disease, provided the first signal of the potential of IL-1β inhibition on lung cancer incidence reduction. Here, we describe the rationale and design for CANOPY-N, a randomized Phase II trial evaluating IL-1β inhibition with or without immune checkpoint inhibition as neoadjuvant treatment in patients with non-small-cell lung cancer. Patients with stage IB to IIIA non-small-cell lung cancer eligible for complete resection will receive canakinumab or pembrolizumab as monotherapy, or in combination. The primary end point is major pathological response by central review; secondary end points include overall response rate, major pathological response (local review), surgical feasibility rate and pharmacokinetics. Clinical trial registration: NCT03968419 (

Keywords: CANOPY; MPR; canakinumab; early stage; immunotherapy; major pathological response; neoadjuvant; non-small-cell lung cancer; resection; surgery.

Plain language summary

Lay abstract A previous study showed that canakinumab reduced the risk of lung cancer in patients with heart disease. Canakinumab blocks an inflammatory protein called IL-1β that is involved in cancer. Anti-cancer drugs used before surgery (‘neo-adjuvant’) can improve the success rate of surgery and may help prevent the cancer from returning. Neo-adjuvant trials help us understand how the drugs work and how they affect cancer. CANOPY-N (NCT03968419) is an ongoing randomized, exploratory, Phase II clinical trial testing canakinumab and pembrolizumab (a different cancer immunotherapy), alone or combined, for patients with early non-small-cell lung cancer. The study will test whether treatment can kill most cancer cells in the surgery sample (‘major pathological response’). It will also investigate other effects on cancer biology, levels of molecules that measure possible clinical benefit (‘biomarkers’) and side effects.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Antibodies, Monoclonal, Humanized / pharmacokinetics
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / pharmacokinetics
  • Carcinoma, Non-Small-Cell Lung / diagnosis
  • Carcinoma, Non-Small-Cell Lung / immunology
  • Carcinoma, Non-Small-Cell Lung / therapy*
  • Clinical Trials, Phase II as Topic
  • Female
  • Humans
  • Interleukin-1beta / antagonists & inhibitors
  • Lung / drug effects
  • Lung / pathology
  • Lung / surgery
  • Lung Neoplasms / diagnosis
  • Lung Neoplasms / immunology
  • Lung Neoplasms / therapy*
  • Male
  • Neoadjuvant Therapy / methods
  • Neoplasm Staging
  • Pneumonectomy
  • Programmed Cell Death 1 Receptor / antagonists & inhibitors
  • Randomized Controlled Trials as Topic
  • Young Adult


  • Antibodies, Monoclonal, Humanized
  • IL1B protein, human
  • Interleukin-1beta
  • PDCD1 protein, human
  • Programmed Cell Death 1 Receptor
  • canakinumab
  • pembrolizumab

Associated data