Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by 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 Cancer NSCLC ACZ885 canakinumab adjuvant AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2) Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.).

Locations

  • University of California at Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills California 90211 United States
  • Los Angeles Hematology/Oncology Medical Group LA Cancer Network accepting new patients
    Los Angeles California 90017 United States

Lead Scientist at UC Cancer

  • Edward B Garon (ucla)
    Associate Professor, Medicine. Authored (or co-authored) 134 research publications.

Details

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