Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design.
Pilar Garrido LopezJean-Louis PujolEdward S KimJay M LeeMasahiro TsuboiAna Gómez-RuedaAmparo BenitoNicolas MorenoLuis GorospeTuochuan DongCecile BlinVanessa Rodrik-OutmezguineVanessa Q PassosTony S K MokPublished in: Future oncology (London, England) (2021)
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).
Keyphrases
- clinical trial
- cardiovascular disease
- monoclonal antibody
- open label
- endothelial cells
- anti inflammatory
- phase ii
- study protocol
- phase iii
- locally advanced
- advanced non small cell lung cancer
- pulmonary embolism
- squamous cell carcinoma
- rectal cancer
- radiation therapy
- randomized controlled trial
- metabolic syndrome
- risk assessment
- cardiovascular risk factors
- human health
- liver metastases