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

Sponsor :


Phase :


Ligne :

2ème ligne (adjuvant)

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

Site :


Contact(s) :
Dr. Alfredo Addeo
Investigateur principal


Rue Gabrielle Perret-Gentil, 4

Cécile Brun

HUG - Unité de recherche clinique DFDL

4, rue Gabrielle-Perret-Gentil

079 553 24 25

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