CANOPY-A: A phase III, multicenter, randomized, double-blind, placebo-controlled trial evaluating canakinumab as adjuvant therapy in patients (pts) with completely resected non-small cell lung cancer (NSCLC).

Abstract

TPS9075 Background: In the CANTOS study, canakinumab (selective IL-1β inhibitor) treatment was associated with reduced incidence and mortality from NSCLC in pts with stable post-myocardial infarction with elevated high-sensitivity C-reactive protein (hs-CRP) levels. In CANOPY-A study, we investigate the therapeutic role of canakinumab in NSCLC. Methods: The CANOPY-A study (NCT03447769) is evaluating the efficacy and safety of canakinumab as adjuvant therapy in adult pts with completely resected NSCLC. Pts with AJCC/UICC v.8 stages II–IIIA and IIIB (T > 5 cm, N2), any histology, completely resected (R0) NSCLC who completed adjuvant cisplatin-based chemotherapy (≥2 cycles) and radiotherapy (if applicable) are eligible. Pts must not have had prior neoadjuvant chemotherapy or radiotherapy. Pts (~1500) are randomized 1:1 to receive canakinumab (200 mg Q3W, SC) or placebo (Q3W, SC) for 18 cycles or until disease recurrence as determined by investigator, unacceptable toxicity, treatment discontinuation at the discretion of the investigator or patient, start of a new antineoplastic therapy, death, or loss to follow-up. Randomization is stratified by AJCC/UICC v.8 stage (IIA vs IIB vs IIIA vs IIIB with T > 5 cm, N2 disease), tumor histology (squamous vs non-squamous), and region (western Europe and North America vs eastern Asia vs rest of the world). Primary objective: disease-free survival (DFS) per local investigator assessment. Secondary objectives: overall survival (OS), lung cancer specific survival, safety, pharmacokinetics, immunogenicity, and patient reported outcomes. Adult pts with stage IIA–IIIA, IIIB (N2 disease only) NSCLC who are candidates for complete resection surgery (and therefore prospective candidates for the main study) will be asked to participate in a biomarker sub-study to understand how resection may impact biomarkers involved in the IL-1β inflammatory pathway and mutations present in blood. In the sub-study, the levels of hs-CRP, other cytokines, and additional biomarkers in blood will be assessed at pre- and post-surgery (endpoint: summary statistics of hs-CRP and other pharmacodynamics [PD] biomarkers). For pts who will enroll in the main study, possible associations between pre- and post-surgery biomarker levels with canakinumab efficacy will be assessed (endpoint: DFS and OS by hs-CRP and other PD biomarkers). The CANOPY-A study is currently enrolling. As of Jan 13, 2020, there are 307 study locations. Clinical trial information: NCT03447769.