Clinical Trial TitleCANOPY-A: Phase III, multi-center, 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).
National Clinical Trial Number:NCT03447769
Clinical Trial Protocol Description:
This is a 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 the subset of IIIB with (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have 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, neuropathy (grade ≤2), and subjects meeting the laboratory specifications.
- Have adequate organ function.
You will be excluded from the study if any of the following criteria apply to you:
- 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.
- Have a history of malignant disease other than the resected NSCLC, significant interstitial lung disease, current diagnosis of cardiac disease, or have not recovered form radiotherapy-related toxicities.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.