for people ages 18 years and up (full criteria)
study started
estimated completion:
Edward B. Garon (ucla)



The primary purpose of the study is to compare 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 (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

Official Title

A Phase III, 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 IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)


Non-Small Cell Lung Cancer NSCLC ACZ885 canakinumab adjuvant AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2) Lung Neoplasms Carcinoma, Non-Small-Cell Lung Antibodies, Monoclonal


You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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


  • University of California at Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • St. Jude Heritage Medical Group Virginia Crosson Cancer Center accepting new patients
    Fullerton California 92835 United States

Lead Scientist

  • Edward B. Garon (ucla)
    Health Sciences Associate Clinical Professor, Medicine. Authored (or co-authored) 109 research publications


accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 3
Study Type
Last Updated