This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Canakinumab; Pembrolizumab
Intervention description: 200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks; 200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACZ885; canakinumab; pembrolizumab; NSCLC; non-small cell lung cancer; non small cell lung cancer; early stage NSCLC; squamous; non-squamous,; MPR; major pathological response; hs-CRP; PD-L1; hsCRP; surgery; neo-adjuvant; neo adjuvant; CD8; hs-IL-6; CANOPY

Summary:

      The purpose of this study was to evaluate the major pathological response (MPR) rate of
      canakinumab given as a neoadjuvant treatment, either as single agent or in combination with
      pembrolizumab, in addition to evaluate the MPR of pembrolizumab as a single agent and the
      dynamic of the tumor microenvironment changes on treatment.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable
             for primary resection by treating surgeon, except for N2 and T4 tumors.

          -  Subject must have been eligible for surgery and with a planned surgical resection in
             approximately 4-6 weeks (after the first dose of study treatment).

          -  A mandatory newly obtained tissue biopsy from primary site was required for study
             enrollment. An archival biopsy was also acceptable if obtained up to 5 months before
             first day of study treatment and if the subject did not go through antineoplastic
             systemic therapies between biopsy collection date and beginning of study treatment.

          -  Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

        Key exclusion criteria:

          -  Subjects with unresectable or metastatic disease.

          -  History of severe hypersensitivity reactions to monoclonal antibodies, which in the
             opinion of the investigator may pose an increased risk of serious infusion reaction

          -  Subjects who received prior systemic therapy (including chemotherapy, other
             anti-cancer therapies and any other antibody or drug specifically targeting T-cell
             co-stimulation or immune checkpoint pathways) in the past 3 years before screening

          -  Active autoimmune disease that has required systemic treatment in the past 2 years
             prior to randomization. Control of the disorder with replacement therapy was permitted

          -  Subject with suspected or proven immunocompromised state or infections