TerminatedPhase 2NCT03968419

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

StatusTerminated
PhasePhase 2
U.S. locations29
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: Canakinumab; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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