Open Actively Recruiting

Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

About

Brief 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.).

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Study Stats
Protocol No.
18-000608
Category
Hematology-Oncology
Oncology
Contact
Karla Russell
Location
  • TRIO-US - Bakersfield
  • TRIO-US - Los Alamitos CA
  • TRIO-US - Wichita KS
  • UCLA Alhambra
  • UCLA Burbank
  • UCLA Encino
  • UCLA Irvine
  • UCLA Pasadena
  • UCLA San Luis Obispo
  • UCLA Santa Monica
  • UCLA Torrance
  • UCLA Valencia
  • UCLA Ventura
  • UCLA Westlake Village
  • UCLA Westwood
For Providers
NCT No.
NCT03447769
For detailed technical eligibility, visit ClinicalTrials.gov.