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)
- Conditions
- Lung cancernon-small cell lung cancer1003866610029107
- Registration Number
- NL-OMON52694
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
• Written informed consent
• Males or females >= 18 years of age.
• Histologically confirmed locally advanced stage IIIB or IV NSCLC; in need
for treatment in the
first-line setting, see protocol paragraph 5.1 item 3 for details.
• Known PD-L1 status determined by a Novartis designated central laboratory,
see protocol
paragraph 5.1 item 5 for details.
• ECOG performance status (PS) of 0 or 1.
• At least 1 measurable lesion by RECIST 1.1.
• Adequate organ function. See protocol paragraph 5.1 item 9 for details
• Previous immunotherapy, see protocol paragraph 5.2 item 1 for details.
• Prior treatment with canakinumab or other IL-1β inhibitor.
• EGFR sensitizing mutations and/or ALK rearrangement. Squamous subjects:
neither EGFR or
ALK testing is required. see protocol paragraph 5.2 item 3 for
details.
• Known active central nervous system (CNS) metastases and/or carcinomatous
meningitis, see protocol paragraph 5.2 item 5 for details.
• Active autoimmune disease that has required systemic treatment in the past 2
years prior to randomization, see protocol paragraph 5.2 item 7 for details.
• Suspected or proven immunocompromised state or infections, see protocol
paragraph 5.2 item
8 for details.
• Live vaccination within 3 months prior to first dose of study drug.
• Pregnant or lactating women, females of childbearing potential and males not
using adequate
contraception. See protocol paragraph 5.2 item 18-20 for details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1: RP3R.<br /><br>Part 2: PFS, OS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1: pharmacokinetic parameters, adverse events, anti-drug antibodies of<br /><br>canakinumab and pembrolizumab, ORR, DCR and DOR.<br /><br>Part 2: ORR, DCR, TTR and DOR, adverse events, pharmacokinetic parameters,<br /><br>anti-drug antibodies of canakinumab and pembrolizumab, questionnaires QLQ-C30,<br /><br>QLQ-LC13 EQ-5D-5L.</p><br>