All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Non-small Cell Lung Cancer
Nov 05, 2019
Jan 31, 2022
18 Years and older (Adult, Older Adult)
200mg administered intravenously every 3 weeks
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.
Mayo Clinic - Arizona
Highlands Oncology Group
University Of California
La Jolla, 92037
Baptist MD Anderson Cancer Center
University of Kansas Medical Center Neurology Dept.