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.
NCT ID: NCT03968419
Last Updated: 2024-06-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
88 participants
INTERVENTIONAL
2019-11-05
2022-08-15
Brief Summary
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Detailed Description
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Subjects were randomized in a 2:2:1 ratio to one of the 3 treatment arms (canakinumab alone or canakinumab in combination with pembrolizumab or pembrolizumab alone). Surgery was performed between 4 to 6 weeks after the first dose of study treatment.
All randomized subjects were followed for safety for up to 130 days following the last dose of study treatment (safety follow-up period).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Canakinumab monotherapy
Participants received 200 mg of canakinumab once every 3 weeks for a maximum duration of 6 weeks prior to surgery
Canakinumab
200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks
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
Canakinumab
200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks
Pembrolizumab
200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks
Pembrolizumab monotherapy
Participants received 200 mg of pembrolizumab every 3 weeks for a maximum duration of 6 weeks prior to surgery
Pembrolizumab
200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks
Interventions
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Canakinumab
200 mg of canakinumab administered via subcutaneous injections once every 3 weeks for a maximum duration of 6 weeks
Pembrolizumab
200 mg of pembrolizumab administered via infusion once every 3 weeks for a maximum duration of 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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UCLA Oncology Hematology
La Jolla, California, United States
University of Kansas Medical Center Neurology Dept.
Kansas City, Kansas, United States
SUNY - Upstate Medical University
Syracuse, New York, United States
Methodist Hospital / Methodist Cancer Center
Houston, Texas, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montpellier, Herault, France
Novartis Investigative Site
Bron, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Bad Berka, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Giessen, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Thessaloniki, , Greece
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
's-Hertogenbosch, , Netherlands
Novartis Investigative Site
Breda, , Netherlands
Novartis Investigative Site
Maastricht, , Netherlands
Novartis Investigative Site
Omsk, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Jaén, Andalusia, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Sakarya, , Turkey (Türkiye)
Novartis Investigative Site
Sihhiye / Ankara, , Turkey (Türkiye)
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Plain Language Trial Summary
Other Identifiers
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2018-004813-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CACZ885V2201C
Identifier Type: -
Identifier Source: org_study_id
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