Study Stopped
Study early terminated due to low enrollment compared to the anticipated figures.
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.
CANOPY-N
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)
2 other identifiers
interventional
88
12 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Nov 2019
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedStudy Start
First participant enrolled
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2022
CompletedResults Posted
Study results publicly available
July 3, 2023
CompletedJune 20, 2024
June 1, 2024
2.5 years
May 15, 2019
June 12, 2023
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Pathological Response (MPR) Rate at the Time of Surgery in Subjects Randomized to Canakinumab Monotherapy and in Combination With Pembrolizumab Based on Central Review
MPR was defined as the percentage of participants with major pathological response (defined as ≤10% residual viable tumor cells on surgical samples). Any participant who had \>10% residual viable cancer cells, or started new antineoplastic therapy prior to surgery, or did not have the surgery performed, or had the surgery performed but with unevaluable MPR result, was considered as a non-responder. MPR was assessed at the time of surgery in all subjects randomized to canakinumab monotherapy and in combination with pembrolizumab based on central review.
At time of surgery (up to 6 weeks after first dose of study treatment)
Secondary Outcomes (12)
Canakinumab Antidrug Antibodies (ADA) Prevalence
Predose (0 hour) on Day 1 of Cycle 1 (Cycle=21 days)
Canakinumab ADA Incidence
From baseline (Predose on Day 1 of Cycle 1) up to 130 days after last dose of study treatment (assessed up to 24.6 weeks). Cycle = 21 days
Pembrolizumab ADA Prevalence
Predose (0 hour) on Day 1 of Cycle 1 (Cycle = 21 days)
Pembrolizumab ADA Incidence
From baseline (Predose on Day 1 of Cycle 1) up to 26 days after last dose of study treatment (assessed up to 10.7 weeks). Cycle = 21 days
Overall Response Rate (ORR) Based on Local Investigator Assessment Using RECIST v1.1
From date of randomization to date of surgery, assessed up to 6 weeks
- +7 more secondary outcomes
Study Arms (3)
Canakinumab monotherapy
EXPERIMENTALParticipants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery
Canakinumab + pembrolizumab
EXPERIMENTALParticipants 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
Pembrolizumab monotherapy
EXPERIMENTALParticipants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery
Interventions
200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks
200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
UCLA Oncology Hematology
La Jolla, California, 92037, United States
University of Kansas Medical Center Neurology Dept.
Kansas City, Kansas, 66160, United States
SUNY - Upstate Medical University
Syracuse, New York, 13210, United States
Methodist Hospital / Methodist Cancer Center
Houston, Texas, 77030, United States
Novartis Investigative Site
Brussels, 1000, Belgium
Novartis Investigative Site
Montreal, Quebec, H2W 1T8, Canada
Novartis Investigative Site
Montpellier, Herault, 34059, France
Novartis Investigative Site
Bron, 69677, France
Novartis Investigative Site
Paris, 75679, France
Novartis Investigative Site
Bad Berka, 99437, Germany
Novartis Investigative Site
Cologne, 51109, Germany
Novartis Investigative Site
Giessen, 35392, Germany
Novartis Investigative Site
Halle, 06120, Germany
Novartis Investigative Site
Thessaloniki, 57001, Greece
Novartis Investigative Site
Kashiwa, Chiba, 277 8577, Japan
Novartis Investigative Site
's-Hertogenbosch, 5200, Netherlands
Novartis Investigative Site
Breda, 4819 EV, Netherlands
Novartis Investigative Site
Maastricht, 6229 HX, Netherlands
Novartis Investigative Site
Omsk, 644013, Russia
Novartis Investigative Site
Saint Petersburg, 195271, Russia
Novartis Investigative Site
Saint Petersburg, 197022, Russia
Novartis Investigative Site
Jaén, Andalusia, 23007, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, 33011, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Taipei, 103616, Taiwan
Novartis Investigative Site
Taipei, 110, Taiwan
Novartis Investigative Site
Izmir, Turkey (Türkiye)
Novartis Investigative Site
Sakarya, 54290, Turkey (Türkiye)
Novartis Investigative Site
Sihhiye / Ankara, 06100, Turkey (Türkiye)
Related Publications (1)
Garrido P, Pujol JL, Kim ES, Lee JM, Tsuboi M, Gomez-Rueda A, Benito A, Moreno N, Gorospe L, Dong T, Blin C, Rodrik-Outmezguine V, Passos VQ, Mok TS. Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design. Future Oncol. 2021 Apr;17(12):1459-1472. doi: 10.2217/fon-2020-1098. Epub 2021 Mar 2.
PMID: 33648347DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 30, 2019
Study Start
November 5, 2019
Primary Completion
April 20, 2022
Study Completion
August 15, 2022
Last Updated
June 20, 2024
Results First Posted
July 3, 2023
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.