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)
Who is this study for? Patients with NSCLC stage IB-IIIA
Status: Terminated
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
UCLA Oncology Hematology
La Jolla
Kansas
University of Kansas Medical Center Neurology Dept.
Kansas City
New York
SUNY - Upstate Medical University
Syracuse
Texas
Methodist Hospital / Methodist Cancer Center
Houston
Other Locations
Belgium
Novartis Investigative Site
Bruxelles
Canada
Novartis Investigative Site
Montreal
France
Novartis Investigative Site
Bron
Novartis Investigative Site
Montpellier Cedex 5
Novartis Investigative Site
Paris
Germany
Novartis Investigative Site
Bad Berka
Novartis Investigative Site
Giessen
Novartis Investigative Site
Halle (saale)
Novartis Investigative Site
Koeln
Greece
Novartis Investigative Site
Thessaloniki
Japan
Novartis Investigative Site
Kashiwa
Netherlands
Novartis Investigative Site
Breda
Novartis Investigative Site
Hertogenbosch
Novartis Investigative Site
Maastricht
Russian Federation
Novartis Investigative Site
Omsk
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
St Petersburg
Spain
Novartis Investigative Site
Jaen
Novartis Investigative Site
Madrid
Novartis Investigative Site
Oviedo
Taiwan
Novartis Investigative Site
Taipei
Novartis Investigative Site
Taipei
Turkey
Novartis Investigative Site
Izmir
Novartis Investigative Site
Sakarya
Novartis Investigative Site
Sihhiye / Ankara
Time Frame
Start Date:2019-11-05
Completion Date:2022-08-15
Participants
Target number of participants:88
Treatments
Experimental: Canakinumab monotherapy
Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery
Experimental: Canakinumab + pembrolizumab
Participants received 200 mg of canakinumab in combination with 200 mg of pembrolizumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery
Experimental: Pembrolizumab monotherapy
Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery