For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
  2. 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.
  3. Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
  4. At least 1 measurable lesion by RECIST 1.1 Key

EXCLUSION CRITERIA

  1. 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).
  2. Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
  3. 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.
  4. Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.
  5. Subject with suspected or proven immune-compromised state or infections.
  6. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


Contition

Non-small Cell Lung Cancer

Age (in years)

18 - 200

Phase

Phase 3

Participants needed

675

Est. Completion Date

Sep 2023

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT03631199

Study number

CACZ885U2301

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