Phase III, multicenter, randomized, double-blind, placebocontrolled 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>5 cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)
Phase III, , Peer Reviewed, Multizentrisch, International
>= 18 Jahre
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.).
Studienaktive Standorte
Klinikum Würzburg Mitte gGmbH (Standort Missioklinik)
Innere Medizin
Herr Dr. Jens Kern
Frau Dr. med Barbara Schröder