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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 20, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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.