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 ( CANOPY 1 )
- Conditions
- Patients with Non-Small Cell Lung CancerNSCLC
- Registration Number
- LBCTR2019070214
- Lead Sponsor
- ovartis Pharma Services Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
Key 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
Key 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-1ß 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: *To compare PFS by local investigator assessment as per RECIST1.1 ;Timepoints: 6 months;Measure: 6 months;Name: Progression free survival;Timepoints: Duing the study ;Measure: during the study
- Secondary Outcome Measures
Name Time Method ame: •Overall response rate (ORR) per investigator assessment using RECIST v1.1 ;Timepoints: baseline, 6 weekd and 12 wee;Measure: baseline, 6 weeks..;Name: •Patient reported outcome (PRO);Timepoints: baseline and every visit ;Measure: baseline and every visit