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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2027
  • participants needed
    1500
  • sponsor
    Novartis Pharmaceuticals
Updated on 15 July 2021
systemic therapy
alopecia
lung carcinoma

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).

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Placebo, canakinumab
Clinical Study IdentifierNCT03447769
SponsorNovartis Pharmaceuticals
Last Modified on15 July 2021

Eligibility

Yes No Not Sure

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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