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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT03447769
• Date of registration: 19/02/2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public 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 Canopy-A
• Scientific 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)
• Date of first enrolment: March 16, 2018
• Target sample size: 1382
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03447769
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lebanon, Malaysia, Mexico, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Had completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease
only) OR had NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and were candidates for
complete resection surgery.

- Cisplatin-based chemotherapy was mandatory for all subjects (Exception: In subjects
with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy could
be administered if recommended by the treating physician). When required, a minimum of
two cycles of cisplatin-based chemotherapy was mandatory, after which additional
therapies could be given based upon local clinical practice and/or guidelines.
Typically, chemotherapy was initiated within 60 days of surgery.

- Radiation therapy was allowed if indicated as per local guidelines or practice.

- Had recovered from all toxicities related to prior systemic therapy to grade = 1
(CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia and
grade 2 or less neuropathy were allowed to enter the study

- Had ECOG performance status (PS) of 0 or 1

Key Exclusion Criteria:

- Had unresectable or metastatic disease, positive microscopic margins on the pathology
report, and/or gross disease remaining at the time of surgery

- Had received any neoadjuvant therapy

- Had presence or history of a malignant disease, other than the resected NSCLC, that
had been diagnosed and/or required therapy within the past 3 years Exceptions to this
exclusion included 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.

- Had a history of current diagnosis of cardiac disease

- Had uncontrolled diabetes

- Had known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C
(positive or indeterminate central laboratory results)

- Subjects had to be evaluated for tuberculosis as per local treatment guidelines or
clinical practice. Subjects with active tuberculosis were not eligible.

- Had 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.).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Canakinumab

Drug: Placebo

Primary Outcome(s)

Disease Free Survival (DFS) by Local Investigator [Time Frame: Up to approximately 4 years]

Secondary Outcome(s)

Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups [Time Frame: Up to approximately 4 years]

Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups [Time Frame: Up to approximately 4 years]

Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire [Time Frame: From baseline up to approximately 4 years]

Canakinumab ADA Incidence [Time Frame: From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years]

Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) [Time Frame: Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.]

Canakinumab Serum Concentrations [Time Frame: Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days]

Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire [Time Frame: From baseline up to approximately 4 years]

Overall Survival (OS) in PD-L1 Subgroups [Time Frame: Up to approximately 4.3 years]

Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire [Time Frame: From baseline up to approximately 4 years]

Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline [Time Frame: Baseline]

Overall Survival (OS) [Time Frame: Up to approximately 4.3 years]

Overall Survival (OS) in CD8 Subgroups [Time Frame: up to approximately 4.3 years]

Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire [Time Frame: From baseline up to approximately 4 years]

Lung Cancer Specific Survival (LCSS) [Time Frame: Up to approximately 4.3 years]

Secondary ID(s)

CACZ885T2301

2017-004011-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/01/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03447769