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
NCT ID: NCT03447769
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1382 participants
INTERVENTIONAL
2018-03-16
2023-02-07
Brief Summary
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Detailed Description
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Approximately 1500 patients were planned to be randomized 1:1 to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo s.c. every 3 weeks. Patients were planned to continue their assigned treatment until they completed 18 cycles (cycle= 21 days) or experienced any one of the following: non-small cell lung cancer (NSCLC) disease recurrence as determined by Investigator; unacceptable toxicity that precluded further treatment; treatment discontinuation at the discretion of the Investigator or patient; start of a new antineoplastic therapy; death, or loss to follow-up, whichever occurred first. All patients who discontinued from the study treatment were to be followed up every 12 weeks for survival until the final OS analysis or death, loss to follow-up or withdrawal of consent for survival follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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canakinumab
Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Canakinumab
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
Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Placebo
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.
Interventions
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Canakinumab
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Had received any neoadjuvant therapy
* Had presence or history of a malignant disease, other than the resected NSCLC, that had been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion included the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer \> 3 years.
* 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.).
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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Highlands Oncology Group .
Fayetteville, Arkansas, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
University of California at Los Angeles
Los Angeles, California, United States
VA Palo Alto Health Care System CRLX030A2301
Palo Alto, California, United States
Sansum Clinic
Santa Barbara, California, United States
Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)
Longmont, Colorado, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Advanced Medical Specialties Drug Ship - 2
Miami, Florida, United States
Florida Cancer Affiliates of Ocala
Ocala, Florida, United States
Florida Cancer Specialists North
St. Petersburg, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Rush University Medical Center Regulatory
Chicago, Illinois, United States
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
Wichita, Kansas, United States
VA Nebraska-W IA Health Care System .
Omaha, Nebraska, United States
Louis Stokes Cleveland Department of Veterans Affairs MC .
Cleveland, Ohio, United States
Oncology Associates of Oregon, PC
Eugene, Oregon, United States
Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology MamieMcFaddenWardCtr
Dallas, Texas, United States
Virginia Cancer Specialists Fairfax Northern Virginia
Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia Inc .
Salem, Virginia, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Sante Fe, Argentina
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Córdoba, , Argentina
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Graz, , Austria
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Klagenfurt, , Austria
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Krems, , Austria
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Vienna, , Austria
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Londrina, Paraná, Brazil
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Teresina, Piauí, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Santiago, , Chile
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Santiago, , Chile
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Hefei, Anhui, China
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Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Guangzhou, Guangdong, China
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Shenzhen, Guangdong, China
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Zhanjing, Guangong, China
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Zunyi, Guizhou, China
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Zhengzhou, Henan, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Changchun, Jilin, China
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Shenyang, Liaoning, China
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Jinan, Shandong, China
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Shanghai, Shanghai Municipality, China
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Xi’an, Shanxi, China
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Shenyang, Shengyang, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Changsha, , China
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Tianjin, , China
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Bogotá, , Colombia
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Ostrava Vitkovice, , Czechia
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Prague, , Czechia
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Marseille, Bouches Du Rhone, France
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Le Mans, Cedex 09, France
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Gerlingen, , Germany
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Leipzig, , Germany
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Nuremberg, , Germany
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Solingen, , Germany
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Athens, Attica, Greece
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Athens, GR, Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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Tuenmen, , Hong Kong
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Törökbálint, Pest County, Hungary
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Veszprém, , Hungary
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Reykjavik, , Iceland
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Mumbai, Maharashtra, India
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Nashik, Maharashtra, India
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Kolkata, West Bengal, India
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Delhi, , India
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Haifa, , Israel
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Holon, , Israel
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Ancona, AN, Italy
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Bari, BA, Italy
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Meldola, FC, Italy
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Ravenna, RA, Italy
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Orbassano, TO, Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Hirosaki, Aomori, Japan
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Matsuyama, Ehime, Japan
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Iizuka, Fukuoka, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Himeji, Hyōgo, Japan
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Kanazawa, Ishikawa-ken, Japan
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Shiwa-gun, Iwate, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Natori-shi, Miyagi, Japan
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Hirakata, Osaka, Japan
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Osaka, Osaka, Japan
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Sakai, Osaka, Japan
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Hidaka, Saitama, Japan
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Sunto Gun, Shizuoka, Japan
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Bunkyo Ku, Tokyo, Japan
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Minato Ku, Tokyo, Japan
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Ube, Yamaguchi, Japan
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Fukuoka, , Japan
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Wakayama, , Japan
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Amman, , Jordan
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Beirut, , Lebanon
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El Achrafiyé, , Lebanon
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Saida, , Lebanon
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Tripoli, , Lebanon
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Kuching, Sarawak, Malaysia
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Kuala Lumpur, , Malaysia
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Pulau Pinang, , Malaysia
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Bergen, , Norway
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Drammen, , Norway
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Oslo, , Norway
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Tromsø, , Norway
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Panama City, , Panama
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San Borja, Lima region, Peru
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Surquillo, Lima region, Peru
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Makati City, , Philippines
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Krakow, Ma3opolska, Poland
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Konin, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Porto, , Portugal
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Floreşti, Cluj, Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Arkhangelsk, , Russia
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Kaliningrad, , Russia
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Moscow Region Istra Village, , Russia
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Obninsk, , Russia
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Omsk, , Russia
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Pushkin Saint Petersburg, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Ljubljana, , Slovenia
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Jeollanam-do, Korea, South Korea
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Seoul, Korea, South Korea
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Cheongju-si, North Chungcheong, South Korea
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Busan, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Córdoba, Andalusia, Spain
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Seville, Andalusia, Spain
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Santander, Cantabria, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Bern, , Switzerland
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Fribourg, , Switzerland
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Geneva, , Switzerland
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Taichung, Taiwan ROC, Taiwan
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Changhua, , Taiwan
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Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Songkhla, Hat Yai, Thailand
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Khon Kaen, THA, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chaingmai, , Thailand
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Pendik Istanbul, Turkey, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Adana, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Cambridge, Cambrigdeshire, United Kingdom
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Truro, Cornwall, United Kingdom
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Cheltenham, Gloucestershire, United Kingdom
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Metropolitan Borough of Wirral, Merseyside, United Kingdom
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Ipswich, Suffolk, United Kingdom
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Guildford, Surrey, United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Preston, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Hanoi, , Vietnam
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2017-004011-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CACZ885T2301
Identifier Type: -
Identifier Source: org_study_id
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