This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.
The purpose of this study was to evaluate the 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 of pembrolizumab as a single agent and the dynamic of the tumor microenvironment changes on treatment.
Checked against the public recordLast updated Jun 20, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: Canakinumab; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 have been 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 was required for study enrollment. An archival biopsy was 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. * 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 was permitted * Subject with suspected or proven immunocompromised state or infections
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Oncology HematologyLa Jolla, California
- University of Kansas Medical Center Neurology Dept.Kansas City, Kansas
- SUNY - Upstate Medical UniversitySyracuse, New York
- Methodist Hospital / Methodist Cancer CenterHouston, Texas
- Novartis Investigative SiteBrussels
- Novartis Investigative SiteMontreal, Quebec
- Novartis Investigative SiteMontpellier, Herault
- Novartis Investigative SiteBron
- Novartis Investigative SiteParis
- Novartis Investigative SiteBad Berka
- Novartis Investigative SiteCologne
- Novartis Investigative SiteGiessen
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 20, 2024. Always confirm current availability with the study team.