TerminatedPhase 3NCT03631199

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

StatusTerminated
PhasePhase 3
U.S. locations152
SponsorNovartis Pharmaceuticals
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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