Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

Summary

This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.

Timeline

Start

2018-12-21

Primary completion

2021-08-09

Completion

2026-01-26

Outcome

Missed primary endpoint

Stopped: “Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns”

paper The addition of canakinumab to first-line pembrolizumab and CT did not prolong PFS or OS in patients with NSCLC. PMID 38039427 ↗

release “CANOPY-1 Phase III study did not meet its primary endpoints of overall survival (OS) and progression-free survival (PFS)” novartis.com ↗

Publications

• Tan DSW, Felip E, de Castro G, Solomon BJ, Greystoke A, Cho BC, Cobo M, Kim TM, Ganguly S, Carcereny E, Paz-Ares L, Bennouna J, Garassino MC, Schenker M, Kim SW, Brase JC, Bury-Maynard D, Passos VQ, Deudon S, Dharan B, Song Y, Caparica R, Johnson BE. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. J Clin Oncol. 2024 Jan 10;42(2):192-204. doi: 10.1200/JCO.23.00980. Epub 2023 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	200 mg	Subcutaneous
Background	Carboplatin	Small molecule	5 unknown	—
Background	Carboplatin	Small molecule	6 unknown	—
Background	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Nab-paclitaxel	Small molecule	100 mg/m2	—
Background	Paclitaxel	Small molecule	200 mg/m2	—
Background	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	—

Indications