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

Abstract

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 (ClinicalTrials.gov).

• Authors: Pilar Garrido, Jean-Louis Pujol, Edward S Kim, Jay M Lee, Masahiro Tsuboi, Ana Gómez-Rueda, Amparo Benito, Nicolas Moreno, Luis Gorospe, Tuochuan Dong, Cecile Blin, Vanessa Rodrik-Outmezguine, Vanessa Q Passos, Tony Sk Mok
• Journal: Future oncology (London, England) (Future Oncol) Vol. 17 Issue 12 Pg. 1459-1472 (Apr 2021) ISSN: 1744-8301 [Electronic] England
• PMID: 33648347 (Publication Type: Clinical Trial Protocol, Journal Article)

Chemical References

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

Topics

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