Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03447769
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    200 mg of canakinumab administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Canakinumab solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.
  • Placebo — DRUG
    Placebo administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Placebo solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.

Study Details

The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T\>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

Key Dates

Start date
Mar 16, 2018
Status verified
Oct 2024
Primary completion
Mar 17, 2022
Completion
Feb 7, 2023

Study Design

Enrollment
1,382 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: canakinumab
    Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
  • Placebo Comparator: Placebo
    Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)

Primary Outcome Measure

Disease Free Survival (DFS) by Local Investigator [ Time Frame: Up to approximately 4 years ]

Locations (21)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group .FayettevilleArkansas72703-
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720-
University of California at Los AngelesLos AngelesCalifornia90095-
VA Palo Alto Health Care System CRLX030A2301Palo AltoCalifornia94304-1207-
Sansum ClinicSanta BarbaraCalifornia93105-
Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)LongmontColorado80501-
Florida Cancer SpecialistsFort MyersFlorida33901-
Advanced Medical Specialties Drug Ship - 2MiamiFlorida33176-
Florida Cancer Affiliates of OcalaOcalaFlorida34474-
Florida Cancer Specialists NorthSt. PetersburgFlorida33705-
Florida Cancer SpecialistsWest Palm BeachFlorida33401-
Rush University Medical Center RegulatoryChicagoIllinois60612-
Cancer Center of Kansas Dept.ofCancerCtr.ofKansasWichitaKansas67214-3728-
VA Nebraska-W IA Health Care System .OmahaNebraska68105-
Louis Stokes Cleveland Department of Veterans Affairs MC .ClevelandOhio44106-
Oncology Associates of Oregon, PCEugeneOregon97401-8122-
Chattanooga Oncology and Hematology Associates PC Chattanooga OncologyChattanoogaTennessee37404-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Texas Oncology MamieMcFaddenWardCtrDallasTexas75246-
Virginia Cancer Specialists Fairfax Northern VirginiaFairfaxVirginia22031-
Oncology and Hematology Associates of Southwest Virginia Inc .SalemVirginia24153-

Find similar trials in Fayetteville, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group .· Fayetteville, ARCancer and Blood Specialty Clinic· Los Alamitos, CAUniversity of California at Los Angeles· Los Angeles, CAVA Palo Alto Health Care System CRLX030A2301· Palo Alto, CASansum Clinic· Santa Barbara, CARocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)· Longmont, CO

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