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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 6 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 17, 2026 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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.