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Purpose

This is 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 subjects. The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
canakinumab 		canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy
  • Drug: canakinumab
    canakinumab every 3 weeks (squamous and non-squamous)
    Other names:
    • ACZ885
  • Drug: canakinumab matching placebo
    canakinumab placebo every 3 weeks (squamous and non-squamous)
  • Drug: pembrolizumab
    200 mg every 3 weeks (squamous and non-squamous)
  • Drug: carboplatin
    Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)
  • Drug: cisplatin
    75 mg/m2 every 3 weeks (non-squamous)
  • Drug: paclitaxel
    200 mg/m2 every 3 weeks (squamous)
  • Drug: nab-paclitaxel
    100 mg/m2 every 3 weeks (squamous)
  • Drug: pemetrexed
    500 mg/m2 every 3 weeks (non-squamous)
Other
canakinumab matching-placebo 		canakinumab matching-placebo in combination with pembrolizumab and platinum-based doublet chemotherapy
  • Drug: canakinumab matching placebo
    canakinumab placebo every 3 weeks (squamous and non-squamous)
  • Drug: pembrolizumab
    200 mg every 3 weeks (squamous and non-squamous)
  • Drug: carboplatin
    Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)
  • Drug: cisplatin
    75 mg/m2 every 3 weeks (non-squamous)
  • Drug: paclitaxel
    200 mg/m2 every 3 weeks (squamous)
  • Drug: nab-paclitaxel
    100 mg/m2 every 3 weeks (squamous)
  • Drug: pemetrexed
    500 mg/m2 every 3 weeks (non-squamous)

More Details

Status
Active, not recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.