None listed
Conditions
Interventions
Canakinumab Type of group
Canakinumab 200 mg every 3 weeks for 18 cycles
Group name:Placebo of Canakinumab Type of group
Canakinumab Placebo 200 mg every 3 weeks for 18 cycles  
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ≥ 18 years 2. Completely resected (R0) AJCC/UICC v. 8 stage IIA with T>4-5 cm and N0 (no nodal involvement), if no adjuvant chemotherapy is given, must be randomized within 70 days post complete surgical resection of their NSCLC. 3. Subjects with completely resected (R0) AJCC/UICC v. 8 stages IIA, IIB, IIIA or IIIB (T>5 cm N2) disease NSCLC, who received chemotherapy and no radiation therapy must be randomized within 182 days post complete surgical resection of their NSCLC. 4. Subjects with completely resected (R0) AJCC/UICC v. 8 stage IIIA N2 (T ≤5 cm only) or stage IIIB (T> 5cm N2) disease who receive radiation therapy along with chemotherapy detailed in inclusion criterion 6, must be randomized within 259 days of complete surgical resection. 5. Adjuvant chemotherapy is mandatory with stage AJCC/UICC v. 8 stage II-IIIA and stage IIIB (T>5cm N2) disease for 4 cycles (21 or 28 day cycles) as per local/national guidelines (except if not tolerated, in which case at least 2 cycles of adjuvant chemotherapy are required). • Adjuvant chemotherapy is mandatory (at least 2 cycles) for all subjects except those who have stage IIA disease with T>4-5 cm. • Chemotherapy must be cisplatin based. Combination partners may include vinorelbine, etoposide, docetaxel or gemcitabine for any histology. For nonsquamous carcinomas only, the combination partner may be pemetrexed.
Exclusion criteria
Exclusion criteria: 1. Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery. 2. Subjects who received neoadjuvant chemotherapy or neoadjuvant radiotherapy. 3. Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. 4. History of interstitial lung disease. 5. History or current diagnosis of cardiac disease, including any of the following: • recent myocardial infarction or coronary artery bypass graft (CABG) surgery within last 6 months, • uncontrolled congestive heart failure, • unstable angina (within last 6 months), • clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker). 6. Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting cycle 1 day 1 or subjects who have not recovered from radiotherapy-related toxicities. Radiation therapy is suggested, but not required to be given to subjects with completely resected (R0) AJCC/UICC v. 8 stage IIIA or IIIB with T>5cm N2 disease, (mediastinal radiation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Assuming proportional hazards model for DFS, the following statistical hypotheses will be tested to address the primary efficacy objective: H01 (null hypotheses): Θ1≥ 0 vs. Ha1 (alternative hypotheses): Θ1 5 cm, Histology: squamous versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW). The primary efficacy variable, DFS, will be analyzed at two interim analyses (first interim that may allow the study to stop due to futility and second interim that may allow the study to declare superior efficacy) and final analysis of a group sequential design, using a Lan-DeMets (O’Brien-Fleming) α-spending function and a non-binding user-defined β-spending function (gamma function with γ=-3). Analyses will be based on the FAS population according to the treatment group and strata assigned at randomization. Measure:The primary objective is to compare the Disease- free survival (DFS) in the canakinumab versus placebo arms as determinated by local investigator assessment Timepoints:The primary objective is to compare the DFS in the canakinumab versus placebo arms as determined by local investigator assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Assuming proportional hazards model for OS, the following statistical hypotheses will be tested only if DFS is statistically significant: H02 (null hypotheses): Θ2≥ 0 vs. Ha2 (alternative hypotheses): Θ2 5cm N2 disease; Histology: squamous versus non-squamous; and Region: Western Europe and North America vs. eastern Asia vs. Rest of the world (RoW). Measure:To compare overall survival (OS) in the canakinumab arm versus placebo arm Timepoints:OS is defined as the time from the date of randomization to the date of death due to any cause. If a subject is not known to have died, then OS will be censored at the latest date the subject was known to be alive (on or before the cut-off date). | — |
Countries
Argentina, Austria, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Jordan, Korea South, Lebano, Malasya, Mexico, Norway, Oman, Panama, Peru, Poland, Portugal, Romania, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United States
Contacts
Public ContactPatricia Castañeda
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed