Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

Summary

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

Timeline

Start

2019-01-23

Primary completion

2021-01-08

Completion

2021-12-20

Outcome

Missed primary endpoint

Stopped: “The study was early terminated due to the lack of efficacy of study treatment observed in the analysis of the primary endpoint of the randomized part”

paper The trial did not meet its primary endpoint of overall survival: PMID 38354535 ↗

registry analysis (superiority test); Randomized Part: Canakinumab + Docetaxel vs Randomized Part: Placebo + Docetaxel; p = 0.633; Hazard Ratio (HR) 1.06 (95% CI 0.76 to 1.48); Log Rank NCT03626545 ↗

release “Phase III CANOPY-2 trial did not meet primary endpoint of overall survival” novartis.com ↗

Publications

• Paz-Ares L, Goto Y, Wan-Teck Lim D, Halmos B, Chul Cho B, Cobo M, Luis Gonzalez Larriba J, Zhou C, Demedts I, Atmaca A, Baka S, Mookerjee B, Portella S, Zhu Z, Wu J, Demanse D, Dharan B, Reck M. Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer. 2024 Mar;189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	200 mg	Subcutaneous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous

Indications