Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design
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, 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
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).
Keywords: CANOPY; MPR; canakinumab; early stage; immunotherapy; major pathological response; neoadjuvant; non-small-cell lung cancer; resection; surgery.
Source: PubMed