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

Official Title

A Phase III, Multicentre, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)

Summary:

The primary purpose of the study is to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

Trial Description

Primary Outcome:

• Disease Free Survival (DFS) by local investigator

• Overall Survival (OS)
• Lung Cancer Specific Survival (LCSS)
• Serum concentration-time profiles of canakinumab and appropriate individual PK parameters based on population PK model
• Serum concentrations of anti-canakinumab antibodies
• Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire
• Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 together with

View this trial on ClinicalTrials.gov