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

Phase 3

• Conditions: on-Small Cell Lung Cancer; NSCLC; C34.9

• Registration Number: LBCTR2019040221
• Lead Sponsor: ovartis Pharma Services Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-11-29
• Study Start: 2023-11-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

•Written informed consent must be obtained prior to any screening procedures
•Subjects 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
•ECOG performance status (PS) of 0 or 1

Exclusion Criteria

•Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
•Subjects who 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.
•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.
•Subjects with suspected or proven immunocompromised state as described in the protocol
•Live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ame: Disease Free Survival ;Timepoints: 5 years;Measure: 5 years

Secondary Outcome Measures

Name	Time	Method
ame: Overall Survival (OS);Timepoints: 5 years;Measure: 5 years;Name: •Lung Cancer Specific Survival (LCSS);Timepoints: 5 years;Measure: 5 years