Study Stopped
Upon review of the primary analysis results, the benefit-risk was assessed by the Steering Committee Members with the decision that the study will be closed. No new safety signals were observed for canakinumab.
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
Canopy-A
A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)
2 other identifiers
interventional
1,382
41 countries
283
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Mar 2018
283 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
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedStudy Start
First participant enrolled
March 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedResults Posted
Study results publicly available
January 30, 2024
CompletedOctober 9, 2024
October 1, 2024
4 years
February 19, 2018
December 27, 2023
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Free Survival (DFS) by Local Investigator
DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.
Up to approximately 4 years
Secondary Outcomes (14)
Overall Survival (OS)
Up to approximately 4.3 years
Overall Survival (OS) in PD-L1 Subgroups
Up to approximately 4.3 years
Overall Survival (OS) in CD8 Subgroups
up to approximately 4.3 years
Lung Cancer Specific Survival (LCSS)
Up to approximately 4.3 years
Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups
Up to approximately 4 years
- +9 more secondary outcomes
Study Arms (2)
canakinumab
EXPERIMENTALParticipants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Placebo
PLACEBO COMPARATORParticipants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Had completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR had NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and were candidates for complete resection surgery.
- Cisplatin-based chemotherapy was mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy could be administered if recommended by the treating physician). When required, a minimum of two cycles of cisplatin-based chemotherapy was mandatory, after which additional therapies could be given based upon local clinical practice and/or guidelines. Typically, chemotherapy was initiated within 60 days of surgery.
- Radiation therapy was allowed if indicated as per local guidelines or practice.
- Had recovered from all toxicities related to prior systemic therapy to grade ≤ 1 (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy were allowed to enter the study
- Had ECOG performance status (PS) of 0 or 1
You may not qualify if:
- Had unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
- Had received any neoadjuvant therapy
- Had a history of current diagnosis of cardiac disease
- Had uncontrolled diabetes
- Had known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
- Subjects had to be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis were not eligible.
- Had suspected or proven immunocompromised state as described in the protocol
- Had live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (283)
Highlands Oncology Group .
Fayetteville, Arkansas, 72703, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
VA Palo Alto Health Care System CRLX030A2301
Palo Alto, California, 94304-1207, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)
Longmont, Colorado, 80501, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Advanced Medical Specialties Drug Ship - 2
Miami, Florida, 33176, United States
Florida Cancer Affiliates of Ocala
Ocala, Florida, 34474, United States
Florida Cancer Specialists North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Rush University Medical Center Regulatory
Chicago, Illinois, 60612, United States
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
Wichita, Kansas, 67214-3728, United States
VA Nebraska-W IA Health Care System .
Omaha, Nebraska, 68105, United States
Louis Stokes Cleveland Department of Veterans Affairs MC .
Cleveland, Ohio, 44106, United States
Oncology Associates of Oregon, PC
Eugene, Oregon, 97401-8122, United States
Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology
Chattanooga, Tennessee, 37404, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology MamieMcFaddenWardCtr
Dallas, Texas, 75246, United States
Virginia Cancer Specialists Fairfax Northern Virginia
Fairfax, Virginia, 22031, United States
Oncology and Hematology Associates of Southwest Virginia Inc .
Salem, Virginia, 24153, United States
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Related Publications (1)
Garon EB, Lu S, Goto Y, De Marchi P, Paz-Ares L, Spigel DR, Thomas M, Yang JC, Ardizzoni A, Barlesi F, Orlov S, Yoshioka H, Mountzios G, Khanna S, Bossen C, Carbini M, Turri S, Myers A, Cho BC. Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial. J Clin Oncol. 2024 Jan 10;42(2):180-191. doi: 10.1200/JCO.23.00910. Epub 2023 Oct 3.
PMID: 37788412DERIVED
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 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2018
First Posted
February 27, 2018
Study Start
March 16, 2018
Primary Completion
March 17, 2022
Study Completion
February 7, 2023
Last Updated
October 9, 2024
Results First Posted
January 30, 2024
Record last verified: 2024-10
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 will be available according to the process described on www.clinicalstudydatarequest.com.