Summary

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

Description

Summary

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)

Keywords

Non-Small Cell Lung CancerNSCLCACZ885canakinumabadjuvantAJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)Lung NeoplasmsCarcinoma, Non-Small-Cell LungAntibodies, Monoclonal

Eligibility

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, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer > 3 years.
  • 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.
  • Subjects with suspected or proven immunocompromised state as described in the protocol
  • Live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).

Locations

  • University of California at Los Angeles accepting new patients
    Los AngelesCalifornia90095United States
  • St. Jude Heritage Medical Group Virginia Crosson Cancer Center accepting new patients
    FullertonCalifornia92835United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03447769
Phase
Phase 3
Study Type
Interventional
Last Updated