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
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Canakinumab; Placebo
Intervention description: 200 mg of canakinumab administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Canakinumab solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.; Placebo administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Placebo solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; NSCLC; ACZ885; canakinumab; adjuvant; AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)

Summary:

      The primary purpose of the study was to compare the efficacy and safety of canakinumab versus
      placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th
      edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer
      Control (UICC) and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small
      cell lung cancer (NSCLC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Had completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease
             only) OR had NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and were candidates for
             complete resection surgery.

          -  Cisplatin-based chemotherapy was mandatory for all subjects (Exception: In subjects
             with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy could
             be administered if recommended by the treating physician). When required, a minimum of
             two cycles of cisplatin-based chemotherapy was mandatory, after which additional
             therapies could be given based upon local clinical practice and/or guidelines.
             Typically, chemotherapy was initiated within 60 days of surgery.

          -  Radiation therapy was allowed if indicated as per local guidelines or practice.

          -  Had recovered from all toxicities related to prior systemic therapy to grade ≤ 1
             (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia and
             grade 2 or less neuropathy were allowed to enter the study

          -  Had ECOG performance status (PS) of 0 or 1

        Key Exclusion Criteria:

          -  Had unresectable or metastatic disease, positive microscopic margins on the pathology
             report, and/or gross disease remaining at the time of surgery

          -  Had received any neoadjuvant therapy

          -  Had presence or history of a malignant disease, other than the resected NSCLC, that
             had been diagnosed and/or required therapy within the past 3 years Exceptions to this
             exclusion included 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.

          -  Had a history of current diagnosis of cardiac disease

          -  Had uncontrolled diabetes

          -  Had known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C
             (positive or indeterminate central laboratory results)

          -  Subjects had to be evaluated for tuberculosis as per local treatment guidelines or
             clinical practice. Subjects with active tuberculosis were not eligible.

          -  Had 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.).