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
This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.
Checked against the public recordLast updated Jun 17, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: canakinumab; Drug: canakinumab-matching placebo; Drug: pembrolizumab; Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: nab-paclitaxel; Drug: pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Pacific Shores Medical GroupLong Beach, California
- USC Kenneth Norris Comprehensive Cancer CenterLos Angeles, California
- AdventHealthOrlando, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- Novartis Investigative SiteCaba, Buenos Aires
- Novartis Investigative SiteCaba
- Novartis Investigative SiteWestmead, New South Wales
- Novartis Investigative SiteWooloongabba, Queensland
- Novartis Investigative SiteMelbourne, Victoria
- Novartis Investigative SiteMurdoch, Western Australia
- Novartis Investigative SiteLinz, Upper Austria
- Novartis Investigative SiteSalzburg
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 17, 2026. Always confirm current availability with the study team.