CACZ885T2301: A 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>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)
Indication :
Cancer bronchique non à petites cellules complètement réséqué, stade II à IIIA et IIIB
Traitement :
Canakimumab versus Placebo
Spécificités :
- Résection complète (R0)
- Stade II à IIIA et IIIB
- Avoir reçu de la chimiothérapie adjuvante
- Exclu: a reçu de la chimiothérapie / radiothérapie néoadjuvante
Contact(s) :
Dr. Alfredo Addeo
Investigateur principal
HUG
Oncologie
Rue Gabrielle Perret-Gentil, 4
1211
Geneva
+41795535035
Alfredo.Addeo@hcuge.ch
Cécile Brun
Coordinatrice
HUG - Unité de recherche clinique DFDL
Oncologie
4, rue Gabrielle-Perret-Gentil
Genève
1211
079 553 24 25
Cecile.Brun@hcuge.ch
Primary objective :
The primary objective is to compare the Diseasefree survival (DFS) in the canakinumab versus placebo arms as determined by local investigator assessment
Inclusion criteria :
Main 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 :
Main 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, and completely resected carcinoma in situ of any type.
- Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
- Subjects with a history of tuberculosis (TB) infection, active or latent, or one of the risk factors described in the protocol
- Subjects with suspected or proven immunocompromised state as described in the protocol
- Live vaccination within 3 months prior to first dose of study drug