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

Key inclusion criteria:

- Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment
in the first-line setting

- Known PD-L1 status determined by a Novartis designated central laboratory. A newly
obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1
determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For
the safety run-in part, known PD-L1 status is not required.

- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

- At least 1 measurable lesion by RECIST 1.1

Key exclusion criteria:

- Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody,
or any other antibody or drug specifically targeting T-cell co-stimulation or immune
checkpoint pathways).

- Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β
inhibitor).

- Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations
(identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved
laboratory testing.

- Previously untreated or symptomatic central nervous system (CNS) metastases or
lepto-meningeal disease.

- Subject with suspected or proven immune-compromised state or infections.

- Subject has prior to starting study drug: received live vaccination ≤3 months, had
major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung
fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone
lesions ≤ 2 weeks.

Other protocol-defined inclusion/exclusion criteria may apply.