Clinical Trial ID: NCT03968419
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)
Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumor microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.
The primary objective is to assess the MPR rate (<10% of residual viable tumor cells) at the time of surgery in evaluable subjects treated with canakinumab alone and in
combination with pembrolizumab based on central review.
Experimental: canakinumab monotherapy
All patients will receive canakinumab (ACZ885) prior to surgery
Experimental: canakinumab + pembrolizumab
All patients will receive canakinumab (ACZ885) and pembrolizumab prior to surgery
Experimental: pembrolizumab monotherapy
All patients will receive 2 doses of pembrolizumab prior to surgery
Baptist MD Anderson Cancer Center
Key inclusion criteria:
Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), 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 primary site is required for study enrollment. An archival biopsy is also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment.
Note: Aspirates will not be accepted.
- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
Key exclusion criteria:
Subjects with unresectable or metastatic disease.
History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening
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
Subject with suspected or proven immunocompromised state or infections
Other protocol-defined inclusion/exclusion criteria may apply.
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