Study of efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects

Prior treatment

• Previous immunotherapy or treatment with IL-1β inhibitor.
• Presence or history of a malignant disease, other than NSCLC, that has been diagnosed and/or required therapy within the past 3 years prior to randomization.
• Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Control of the disorder with replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is permitted.

Other illness

• History of severe hypersensitivity reaction to monoclonal antibodies, platinum containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of these drugs
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.

Lab values

• Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations and/or ALK rearrangement

Other

• Other protocol-defined exclusion criteria may apply.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Histologically confirmed locally advanced or metastatic NSCLC
• Measurable disease by RECIST 1.1
• Known PD-L1 status
• ECOG performance status (PS) ≤ 1.
• Other protocol-defined inclusion criteria may apply.