Description:
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).
Title
- Brief Title: 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, Multicenter, 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)
Clinical Trial IDs
- ORG STUDY ID:
CACZ885T2301
- SECONDARY ID:
2017-004011-39
- NCT ID:
NCT03447769
Conditions
- Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Canakinumab | ACZ885 | canakinumab |
Placebo | | Placebo |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
canakinumab | Experimental | Participants will be administered receive canakinumab for 18 cycles (approximately 54 weeks). | |
Placebo | Placebo Comparator | Participants will be administered receive canakinumab placebo for 18 cycles (approximately 54 weeks). | |
Eligibility Criteria
Inclusion Criteria:
- Have completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease
only) OR have NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and are candidates for
complete resection surgery
- Must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1
(CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and
grade 2 or less neuropathy are allowed to enter the study
- Have ECOG performance status (PS) of 0 or 1
Exclusion Criteria:
- Have unresectable or metastatic disease, positive microscopic margins on the pathology
report, and/or gross disease remaining at the time of surgery
- Have received neoadjuvant chemotherapy or neoadjuvant radiotherapy
- 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, completely resected carcinoma in situ of any type and hormonal maintenance
for breast and prostate cancer > 3 years.
- Have a history of current diagnosis of cardiac disease
- Have uncontrolled diabetes
- Have known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C
(positive or indeterminate central laboratory results)
- Subjects must be evaluated for tuberculosis as per local treatment guidelines or
clinical practice. Subjects with active tuberculosis are not eligible.
- Have suspected or proven immunocompromised state as described in the protocol
- Had Live and attenuated vaccination within 3 months prior to first dose of study drug
(e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease Free Survival (DFS) by local investigator |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | DFS will be assessed from the time from the date of randomization to the date of the first documented disease recurrence as assessed by local investigator radiologically or death due to any cause. |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. |
Measure: | Lung Cancer Specific Survival (LCSS) |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | To compare lung cancer specific survival in the canakinumab arm versus placebo arm |
Measure: | Serum concentration-time profiles of canakinumab and appropriate individual PK parameters based on population PK model |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | To characterize the pharmacokinetics of canakinumab therapy |
Measure: | Serum concentrations of anti-canakinumab antibodies |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab |
Measure: | Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | To assess the effect of canakinumab versus placebo on PROs (EORTC QLQC30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health related quality of life |
Measure: | Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 together with |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | To assess the effect of canakinumab versus placebo on PROs (EORTC QLQC30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health related quality of life |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Non-Small Cell Lung Cancer
- NSCLC
- ACZ885
- canakinumab
- adjuvant
- AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)
Last Updated
August 9, 2021