CANOPY-1
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1)
IRAS ID
254066
Contact name
Alastair Greystoke
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-001547-32
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 9 months, 8 days
Research summary
Inflammation is known to play a key role in the development and spread of Non-Small Cell Lung Cancer (NSCLC). Canakinumab has been shown to suppress levels of C-reactive protein (CRP), a known factor in the inflammatory response. A cardiovascular study, investigating canakinumab as an inflammatory suppressant, measured occurrence and mortality of NSCLC as secondary endpoints and found both to be significantly decreased. Additionally, the suppression of CRP levels correlated with responses in NSCLC patients that were treated with canakinumab.
This study has been designed to find out a) how well patients respond when they receive standard of care NSCLC treatment (combination pembrolizumab (immunotherapy)/ platinum-based doublet chemotherapy) and canakinumab, compared with standard of care and canakinumab matching-placebo, and b) how safe it is to treat patients with canakinumab combined with the standard of care. The study is divided into two parts: 1. Safety run-in and 2. Randomised. During part 1, 27 patients will be treated across 3 cohorts to confirm the recommended Phase 3 dose regimen of canakinumab. The dose will be confirmed when 6 evaluable subjects from each cohort have been observed for dose limiting toxicity for 42 days. For part 2, patients will be randomised 1:1 to receive canakinumab or placebo, in addition to standard of care.
The safety and efficacy will be measured by looking at how long patients respond to the treatment without their cancer progressing and the overall survival of all patients. Additional objectives of the study are to understand how the mechanism of the response works by measuring how quickly the drugs are absorbed and what molecules are involved in the response. Patients will be treated for a maximum of 35 cycles (maximum treatment duration of pembrolizumab) unless they stop treatment due to progression or dose-limiting toxicities.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0067
Date of REC Opinion
2 Apr 2019
REC opinion
Further Information Favourable Opinion