Non-Small Cell Lung CancerPhase 3Canopy-ANCT03447769
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
A Phase 3 study testing Canakinumab in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 283 sites in 41 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Canakinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,382 participants
- Where
- 283 sitesin 41 countries
- Study dates
- 16 Mar 2018to 7 Feb 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 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)
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- 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.).
Trial locations and contacts
283 sites in 41 countries.
283 sites in 41 countries
China26 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100039
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Changsha, 410013
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chengdu, 610044
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400037
Novartis Investigative Site
Fujian, 350001
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Novartis Investigative Site
Hangzhou, Zhejiang, 310003
Novartis Investigative Site
Hangzhou, Zhejiang, 310022
Novartis Investigative Site
Hefei, Anhui, 230001
Novartis Investigative Site
Jinan, Shandong, 250117
Novartis Investigative Site
Nanjing, Jiangsu, 210008
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200032
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200433
Novartis Investigative Site
Shenyang, Liaoning, 110011
Novartis Investigative Site
Shenyang, Shengyang, 110041
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Shenzhen, Guangdong, 518020
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Suzhou, Jiangsu, 215004
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Tianjin, 300000
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Tianjin, 300052
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Xi’an, Shanxi, 710061
Novartis Investigative Site
Zhanjing, Guangong, 524000
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Zhengzhou, Henan, 450008
Novartis Investigative Site
Zunyi, Guizhou, 563000
Germany25 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Berlin, 12351
Novartis Investigative Site
Berlin, 13125
Novartis Investigative Site
Berlin, 14165
Novartis Investigative Site
Bochum, North Rhine-Westphalia, 44791
Novartis Investigative Site
Chemnitz, 09113
Novartis Investigative Site
Cologne, 51109
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Dresden, 01307
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Erfurt, 99089
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Essen, 45147
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Gauting, Bavaria, 82131
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Georgsmarienhütte, 49124
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Gera, 07548
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Gerlingen, 70839
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Großhansdorf, 22947
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Halle, 06120
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Heidelberg, Baden-Wurttemberg, 69126
Novartis Investigative Site
Leipzig, D-04347
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Minden, 32429
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München, 81377
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Nuremberg, 90419
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Solingen, 42699
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Ulm, 89081
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Velbert, North Rhine-Westphalia, 42551
Novartis Investigative Site
Würzburg, 97074
Japan25 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 070-8644
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113-8431
Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045
Novartis Investigative Site
Fukuoka, 810-8563
Novartis Investigative Site
Hidaka, Saitama, 350-1298
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Himeji, Hyōgo, 670-8520
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Hirakata, Osaka, 573-1191
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Hirosaki, Aomori, 036 8563
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Iizuka, Fukuoka, 820-8505
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Kanazawa, Ishikawa-ken, 920-8641
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Matsuyama, Ehime, 791-0280
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Minato Ku, Tokyo, 105-8470
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Nagoya, Aichi-ken, 464 8681
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Nagoya, Aichi-ken, 466 8560
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Natori-shi, Miyagi, 981-1293
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Osaka, Osaka, 541-8567
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Osaka, 545-8586
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Sakai, Osaka, 591-8555
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Sapporo, Hokkaido, 060 8648
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Shiwa-gun, Iwate, 028-3695
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Sunto Gun, Shizuoka, 411 8777
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Ube, Yamaguchi, 755-0241
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Wakayama, 641-8510
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Yokohama, Kanagawa, 236 0051
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Yokohama, Kanagawa, 241-8515
France22 sites
Novartis Investigative Site
Amiens, 80054
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Angers, 49933
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Avignon, 84902
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Bayonne, 64109
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Brest, 29200
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Bron, 69677
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Clermont-Ferrand, 63000
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Créteil, 94000
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La Rochelle, 17019
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La Seyne-sur-Mer, 83500
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Le Mans, Cedex 09, 72037
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Lille, 59000
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Marseille, Bouches Du Rhone, 13915
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Montpellier, Herault, 34059
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Paris, 75014
Novartis Investigative Site
Paris, 75231
Novartis Investigative Site
Pessac, 33604
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Poitiers, 86000
Novartis Investigative Site
Saint-Herblain Cédex, 44805
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Strasbourg, 67091
Novartis Investigative Site
Suresnes, 92150
Novartis Investigative Site
Toulouse, 31400
United States21 sites
Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology
Chattanooga, Tennessee, 37404
Rush University Medical Center Regulatory
Chicago, Illinois, 60612
Louis Stokes Cleveland Department of Veterans Affairs MC .
Cleveland, Ohio, 44106
Texas Oncology MamieMcFaddenWardCtr
Dallas, Texas, 75246
Oncology Associates of Oregon, PC
Eugene, Oregon, 97401-8122
Virginia Cancer Specialists Fairfax Northern Virginia
Fairfax, Virginia, 22031
Highlands Oncology Group .
Fayetteville, Arkansas, 72703
Florida Cancer Specialists
Fort Myers, Florida, 33901
Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)
Longmont, Colorado, 80501
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
University of California at Los Angeles
Los Angeles, California, 90095
Advanced Medical Specialties Drug Ship - 2
Miami, Florida, 33176
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Florida Cancer Affiliates of Ocala
Ocala, Florida, 34474
VA Nebraska-W IA Health Care System .
Omaha, Nebraska, 68105
VA Palo Alto Health Care System CRLX030A2301
Palo Alto, California, 94304-1207
Oncology and Hematology Associates of Southwest Virginia Inc .
Salem, Virginia, 24153
Sansum Clinic
Santa Barbara, California, 93105
Florida Cancer Specialists North
St. Petersburg, Florida, 33705
Florida Cancer Specialists
West Palm Beach, Florida, 33401
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
Wichita, Kansas, 67214-3728
United Kingdom15 sites
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bristol, BS2 8HN
Novartis Investigative Site
Cambridge, Cambrigdeshire, CB2 0QQ
Novartis Investigative Site
Cheltenham, Gloucestershire, GL53 7AN
Novartis Investigative Site
Guildford, Surrey, GU2 7XX
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Ipswich, Suffolk, IP4 5PD
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Leicester, LE1 5WW
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London, EC14 7BE
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London, NW3 2QG
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Metropolitan Borough of Wirral, Merseyside, CH63 4JY
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Nottingham, NG5 1PB
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Oxford, OX3 7LJ
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Preston, PR2 9HT
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Stoke-on-Trent, ST4 6QG
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Truro, Cornwall, TR1 3LJ
Italy12 sites
Novartis Investigative Site
Ancona, AN, 60126
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Aviano, PN, 33081
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Bari, BA, 70124
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Meldola, FC, 47014
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Milan, MI, 20132
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Milan, MI, 20133
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Monza, MB, 20900
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Orbassano, TO, 10043
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Padova, PD, 35100
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Perugia, PG, 06129
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Ravenna, RA, 48100
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Roma, RM, 00189
Spain12 sites
Novartis Investigative Site
Badalona, Catalonia, 08916
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28041
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41013
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Valencia, Valencia, 46010
Russia11 sites
Novartis Investigative Site
Arkhangelsk, 163045
Novartis Investigative Site
Kaliningrad, 236006
Novartis Investigative Site
Moscow Region Istra Village, 143423
Novartis Investigative Site
Obninsk, 249036
Novartis Investigative Site
Omsk, 644013
Novartis Investigative Site
Pushkin Saint Petersburg, 196603
Novartis Investigative Site
Ryazan, 390011
Novartis Investigative Site
Saint Petersburg, 192148
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saint Petersburg, 197758
Novartis Investigative Site
Yaroslavl, 150054
Taiwan10 sites
Novartis Investigative Site
Changhua, 50006
Novartis Investigative Site
Hualien City, 970
Novartis Investigative Site
Kaohsiung City, 82445
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Taichung, Taiwan ROC, 40201
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taichung, 40705
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taoyuan, 33305
South Korea7 sites
Novartis Investigative Site
Busan, 48108
Novartis Investigative Site
Cheongju-si, North Chungcheong, 28644
Novartis Investigative Site
Jeollanam-do, Korea, 58128
Novartis Investigative Site
Seoul, Korea, 08308
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05505
Thailand7 sites
Novartis Investigative Site
Bangkok, 10300
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chaingmai, 50200
Novartis Investigative Site
Khon Kaen, THA, 40002
Novartis Investigative Site
Songkhla, Hat Yai, 90110
Greece6 sites
Novartis Investigative Site
Athens, Attica, 15562
Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, 11526
Novartis Investigative Site
Athens, 18547
Novartis Investigative Site
Athens, GR14564
Novartis Investigative Site
Thessaloniki, 57001
Poland6 sites
Novartis Investigative Site
Konin, 62 500
Novartis Investigative Site
Krakow, Ma3opolska, 31-826
Novartis Investigative Site
Olsztyn, 10-288
Novartis Investigative Site
Poznan, 60-693
Novartis Investigative Site
Rzeszów, 35-021
Novartis Investigative Site
Warsaw, 02 781
Argentina5 sites
Novartis Investigative Site
CABA, Buenos Aires, C1426ANZ
Novartis Investigative Site
Córdoba, X5016KEH
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DSV
Novartis Investigative Site
Rosario, Sante Fe, S200KZE
Brazil5 sites
Novartis Investigative Site
Barretos, São Paulo, 14784 400
Novartis Investigative Site
Londrina, Paraná, 86015-520
Novartis Investigative Site
São Paulo, São Paulo, 01246 000
Novartis Investigative Site
São Paulo, São Paulo, 04014-002
Novartis Investigative Site
Teresina, Piauí, 64049-200
Canada5 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
Halifax, Nova Scotia, B3H 1V7
Novartis Investigative Site
Moncton, New Brunswick, E1C 6Z8
Novartis Investigative Site
Montreal, Quebec, H2W 1T8
Novartis Investigative Site
Québec, Quebec, GIV 4G5
Georgia5 sites
Novartis Investigative Site
Batumi, 6000
Novartis Investigative Site
Tbilisi, 0144
Novartis Investigative Site
Tbilisi, 0159
Novartis Investigative Site
Tbilisi, 0160
Novartis Investigative Site
Tbilisi, 112
Turkey (Türkiye)5 sites
Novartis Investigative Site
Adana, 01250
Novartis Investigative Site
Ankara, Yenimahalle, 06200
Novartis Investigative Site
Istanbul, 34303
Novartis Investigative Site
Izmir, 35575
Novartis Investigative Site
Pendik Istanbul, Turkey, 34899
Austria4 sites
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Klagenfurt, 9020
Novartis Investigative Site
Krems, A-3500
Novartis Investigative Site
Vienna, A 1090
Bulgaria4 sites
Novartis Investigative Site
Sofia, 1303
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Sofia, 1407
Novartis Investigative Site
Sofia, 1756
Novartis Investigative Site
Sofia, 1784
India4 sites
Novartis Investigative Site
Delhi, 110 085
Novartis Investigative Site
Kolkata, West Bengal, 700160
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Mumbai, Maharashtra, 400022
Novartis Investigative Site
Nashik, Maharashtra, 422 004
Lebanon4 sites
Novartis Investigative Site
Beirut, 10999
Novartis Investigative Site
El Achrafiyé, 166830
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Saida, 652
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Tripoli, 1434
Norway4 sites
Novartis Investigative Site
Bergen, 5021
Novartis Investigative Site
Drammen, 3004
Novartis Investigative Site
Oslo, 0424
Novartis Investigative Site
Tromsø, 9019
Romania4 sites
Novartis Investigative Site
Bucharest, 010991
Novartis Investigative Site
Cluj-Napoca, 400124
Novartis Investigative Site
Floreşti, Cluj, 407280
Novartis Investigative Site
Iași, 700483
Hong Kong3 sites
Novartis Investigative Site
Hong Kong
Novartis Investigative Site
Kowloon
Novartis Investigative Site
Tuenmen, 999077
Malaysia3 sites
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuching, Sarawak, 93586
Novartis Investigative Site
Pulau Pinang, 10990
Portugal3 sites
Novartis Investigative Site
Lisbon, 1769-001
Novartis Investigative Site
Matosinhos Municipality, 4454 513
Novartis Investigative Site
Porto, 4100-180
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Fribourg, 1708
Novartis Investigative Site
Geneva, CH 1211
Chile2 sites
Novartis Investigative Site
Santiago, 7500006
Novartis Investigative Site
Santiago, 7500921
Czechia2 sites
Novartis Investigative Site
Ostrava Vitkovice, 703 84
Novartis Investigative Site
Prague, 128 21
Hungary2 sites
Novartis Investigative Site
Törökbálint, Pest County, 2045
Novartis Investigative Site
Veszprém, 8200
Israel2 sites
Novartis Investigative Site
Haifa, 3109601
Novartis Investigative Site
Holon, 58100
Peru2 sites
Novartis Investigative Site
San Borja, Lima region, 41
Novartis Investigative Site
Surquillo, Lima region, 34
About this study
Official title: 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)
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).
Read the detailed description
This was a phase III, multicenter, randomized, double-blind study to evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult patients with stages AJCC/UICC v.8 II-IIIA and IIIB (T>5 cm N2) completely resected (R0) NSCLC.
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
- Non-Small Cell Lung Cancer
- Being tested
- Canakinumab, Placebo
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, ACZ885, canakinumab, adjuvant, AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called ACZ885
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| canakinumab | Experimental | Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks) Receives: Drug: Canakinumab |
| Placebo | Placebo comparator | Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 4 years
Secondary outcomes (14)
Overall Survival (OS)
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.
Measured: Up to approximately 4.3 years
Overall Survival (OS) in PD-L1 Subgroups
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 <1%, PD-L1 ≥1% and <49%, and PD-L1 ≥50%.
Measured: Up to approximately 4.3 years
Overall Survival (OS) in CD8 Subgroups
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.
Measured: up to approximately 4.3 years
Lung Cancer Specific Survival (LCSS)
LCSS is defined as the time from date of randomization to the date of death due to lung cancer. The LCSS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.
Measured: Up to approximately 4.3 years
Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups
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.
DFS analysis was performed by baseline programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 <1%, PD-L1 ≥1% and <49%, and PD-L1 ≥50%.
Measured: Up to approximately 4 years
Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups
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.
DFS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.
Measured: Up to approximately 4 years
Canakinumab Serum Concentrations
Serum concentrations of canakinumab were determinded using an ELISA method.
Measured: Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days
Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline
Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline
Measured: Baseline
Canakinumab ADA Incidence
Canakinumab ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)
Measured: From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years
Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.
The time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this threshold or death due to any cause, whichever occurred earlier.
Measured: From baseline up to approximately 4 years
Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.
The time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occured earlier.
Measured: From baseline up to approximately 4 years
Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.
The time to first 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.
Measured: From baseline up to approximately 4 years
Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.
The time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.
Measured: From baseline up to approximately 4 years
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L)
EQ-5D-5L was a standardized questionnaire that measured health-related QoL. EQ-5D-5L consisted of 2 components: a health state profile and a visual analogue scale. The health state profile included five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels ranging from 1 (no problems) to 5 (extreme problems).
The EQ-5D-5L health state profile responses were converted into single index utility score, ranging from -1 to 1, where lower scores representing a higher level of dysfunction. Published weights are available enabling the calculation of the utility score. A positive change from baseline indicated improvement. This endpoint was assessed throughout the study, including safety and efficacy follow-up (FU) visits. Safety FU visits: every 4 weeks after end of treatment up to 130 days post-last dose. Efficacy FU visits: at 18, 24, 30, 36 and 48 months post-randomization (if no recurrence observed during treatment or safety FU)
Measured: Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start16 Mar 2018
- Primary completion17 Mar 2022
- Study completion7 Feb 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447769
- Sponsor's protocol ID
- CACZ885T2301
- Other IDs
- 2017-004011-39, 2017
- Acronym
- Canopy-A
- Status last verified
- Oct 2024
- First submitted
- 19 Feb 2018
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37788412