癌研連線CancerLink
Terminated NCT03631199

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

Non-Small Cell Lung CancerPhase 3Stage IIIStage IVEGFRALKPD-L1

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.

Conditions: Non-small Cell Lung Cancer

Eligibility Criteria

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

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.

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.