A randomized, open-label, phase II study of canakinumab or pembrolizumab as monotherapy or in combination as neoadjuvant therapy in subjects with resectable non-small cell lung cancer (CANOPY-N)
- Conditions
- lung cancernon-small cell lung cancer1003866610029107
- Registration Number
- NL-OMON55116
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
• Males or females >= 18 years of age.
• Histologically confirmed NSCLC stage IB-IIIA, deemed suitable for primary
resection by treating surgeon, except for N2 and T4 tumors.
• Subject must be eligible for surgery and with a planned surgical resection in
approximately 4-6 weeks (after the first dose of study treatment).
• A mandatory newly obtained tissue biopsy from a primary site is required for
study enrollment. An archival biopsy is conditionally acceptable. See protocol
paragraph 5.1, item 5 for details.
• ECOG performance status of 0 or 1.
• Adequate organ function. See protocol paragraph 5.1 item 6 for details
• Unresectable or metastatic disease, see protocol paragraph 5.2 item 1 for
details.
• History of severe hypersensitivity reactions to monoclonal antibodies, which
in the opinion of the investigator may pose an increased risk of serious
infusion reaction.
• Presence or history of a malignant disease that has been diagnosed and/or
required therapy within the past 3 years. See protocol paragraph 5.2 item 3 for
details.
• Prior systemic in the past 3 years before screening. See protocol paragraph
5.2 item 4 for details.
• Uncontrolled diabetes.
• Clinically significant, uncontrolled heart disease and/or recent cardiac
event, see protocol paragraph 5.2, item 8.
• Suspected or proven immunocompromised state or infections, see protocol
paragraph 5.2 item 10 for details.
• Pregnant or lactating women, females of childbearing potential not using
adequate contraception. See protocol paragraph 5.2 item 13-14 for details.
- Active autoimmune disease that has required systemic treatment in the
past 2 years prior to randomization Control of the disorder with replacement
therapy is permitted
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>MPR (major pathological response rate, central assessment) at the time of<br /><br>surgery (by number of subject with <= 10% residual viable cancer cells).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Radiological tumor assessments prior to surgery, MPR local assessment, physical<br /><br>examination, ECOG performance status, adverse events.</p><br>