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. (CANOPY-1)
Phase 3
Completed
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- jRCT2080224543
- Lead Sponsor
- Novartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 627
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.
- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
- At least 1 measurable lesion by RECIST 1.1
Exclusion Criteria
- Previous immunotherapy or drugs of a similar mechanism of action (IL-1 beta inhibitor).
- Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations, and/or ALK rearrangement by locally approved laboratory testing.
Study & Design
- Study Type
- Interventional
- Study Design
- Multicenter, randomized, double-blind, placebo-controlled
- Primary Outcome Measures
Name Time Method Incidence of DLTs 42 days Assessed among at least 6 evaluable subjects during the first 42 days of study treatment
Progression free survival Defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan/Asia except Japan
Location not specified
Japan/Asia except Japan