Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Summary

The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T\>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

Timeline

Start

2018-03-16

Primary completion

2022-03-17

Completion

2023-02-07

Outcome

Missed primary endpoint

Stopped: “Upon review of the primary analysis results, the benefit-risk was assessed by the Steering Committee Members with the decision that the study will be closed. No new safety signals were observed for canakinumab.”

paper This study did not meet its primary end point. PMID 37788412 ↗

registry analysis (superiority test); Canakinumab vs Placebo; p = 0.258; Hazard Ratio (HR) 0.94 (95% CI 0.78 to 1.14) NCT03447769 ↗

release “Phase III CANOPY-A trial did not meet primary endpoint of disease-free survival in patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer” novartis.com ↗

Publications

• Garon EB, Lu S, Goto Y, De Marchi P, Paz-Ares L, Spigel DR, Thomas M, Yang JC, Ardizzoni A, Barlesi F, Orlov S, Yoshioka H, Mountzios G, Khanna S, Bossen C, Carbini M, Turri S, Myers A, Cho BC. Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial. J Clin Oncol. 2024 Jan 10;42(2):180-191. doi: 10.1200/JCO.23.00910. Epub 2023 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	200 mg	Subcutaneous

Indications