A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)
Description
Brief Summary
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.
Phase
N/AInclusion and Exclusion 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
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por
SC CTSI