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)

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).

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Canakinumab; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1382
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5016KEH
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1426ANZ
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSV
      • Novartis Investigative Site
  • Sante Fe
    • Rosario, Sante Fe, Argentina, S200KZE
      • Novartis Investigative Site
• Austria
  • Graz, Austria, 8036
    • Novartis Investigative Site
  • Klagenfurt, Austria, 9020
    • Novartis Investigative Site
  • Krems, Austria, A-3500
    • Novartis Investigative Site
  • Vienna, Austria, A 1090
    • Novartis Investigative Site
• Brazil
  • PR
    • Londrina, PR, Brazil, 86015-520
      • Novartis Investigative Site
  • Piaui
    • Teresina, Piaui, Brazil, 64049-200
      • Novartis Investigative Site
  • SP
    • Barretos, SP, Brazil, 14784 400
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 01246 000
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 04014-002
      • Novartis Investigative Site
• Bulgaria
  • Sofia, Bulgaria, 1756
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1407
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1303
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1784
    • Novartis Investigative Site
• Canada
  • Quebec, Canada, GIV 4G5
    • Novartis Investigative Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Novartis Investigative Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Novartis Investigative Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
      • Novartis Investigative Site
• Chile
  • Santiago, Chile, 7500921
    • Novartis Investigative Site
  • Santiago, Chile, 7500006
    • Novartis Investigative Site
• China
  • Beijing, China, 100036
    • Novartis Investigative Site
  • Changsha, China, 410013
    • Novartis Investigative Site
  • Chengdu, China, 610044
    • Novartis Investigative Site
  • Fujian, China, 350001
    • Novartis Investigative Site
  • Tianjin, China, 300052
    • Novartis Investigative Site
  • Tianjin, China, 300000
    • Novartis Investigative Site
  • Anhui
    • Hefei, Anhui, China, 230001
      • Novartis Investigative Site
  • Beijing
    • Beijing, Beijing, China, 100039
      • Novartis Investigative Site
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Novartis Investigative Site
    • Shenzhen, Guangdong, China, 518020
      • Novartis Investigative Site
  • Guangong
    • Zhanjing, Guangong, China, 524000
      • Novartis Investigative Site
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Novartis Investigative Site
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Novartis Investigative Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Novartis Investigative Site
    • Suzhou, Jiangsu, China, 215004
      • Novartis Investigative Site
  • Jilin
    • Chang Chun, Jilin, China, 130021
      • Novartis Investigative Site
  • Liaoning
    • Shenyang, Liaoning, China, 110011
      • Novartis Investigative Site
  • Shandong
    • Jinan, Shandong, China, 250117
      • Novartis Investigative Site
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Novartis Investigative Site
    • Shanghai, Shanghai, China, 200433
      • Novartis Investigative Site
  • Shanxi
    • XI An, Shanxi, China, 710061
      • Novartis Investigative Site
  • Shengyang
    • Shenyang, Shengyang, China, 110041
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Novartis Investigative Site
    • Hangzhou, Zhejiang, China, 310022
      • Novartis Investigative Site
• Colombia
  • Bogota, Colombia, 110221
    • Novartis Investigative Site
• Czechia
  • Ostrava Vitkovice, Czechia, 703 84
    • Novartis Investigative Site
  • Prague 2, Czechia, 128 21
    • Novartis Investigative Site
• France
  • Amiens, France, 80054
    • Novartis Investigative Site
  • Angers Cedex 9, France, 49933
    • Novartis Investigative Site
  • Avignon Cedex, France, 84902
    • Novartis Investigative Site
  • Bayonne, France, 64109
    • Novartis Investigative Site
  • Brest, France, 29200
    • Novartis Investigative Site
  • Bron, France, 69677
    • Novartis Investigative Site
  • Clermont-Ferrand, France, 63000
    • Novartis Investigative Site
  • Creteil, France, 94000
    • Novartis Investigative Site
  • La Rochelle, France, 17019
    • Novartis Investigative Site
  • La Seyne sur mer, France, 83500
    • Novartis Investigative Site
  • Lille, France, 59000
    • Novartis Investigative Site
  • Paris, France, 75231
    • Novartis Investigative Site
  • Paris, France, 75014
    • Novartis Investigative Site
  • Pessac Cedex, France, 33604
    • Novartis Investigative Site
  • Poitiers, France, 86000
    • Novartis Investigative Site
  • Saint-Herblain Cédex, France, 44805
    • Novartis Investigative Site
  • Strasbourg Cedex, France, 67091
    • Novartis Investigative Site
  • Suresnes, France, 92150
    • Novartis Investigative Site
  • Toulouse, France, 31400
    • Novartis Investigative Site
  • Bouches Du Rhone
    • Marseille cedex 20, Bouches Du Rhone, France, 13915
      • Novartis Investigative Site
  • Cedex 09
    • Le Mans, Cedex 09, France, 72037
      • Novartis Investigative Site
  • Herault
    • Montpellier cedex 5, Herault, France, 34059
      • Novartis Investigative Site
• Georgia
  • Batumi, Georgia, 6000
    • Novartis Investigative Site
  • Tbilisi, Georgia, 0144
    • Novartis Investigative Site
  • Tbilisi, Georgia, 0159
    • Novartis Investigative Site
  • Tbilisi, Georgia, 0160
    • Novartis Investigative Site
  • Tbilisi, Georgia, 112
    • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52074
    • Novartis Investigative Site
  • Berlin, Germany, 13125
    • Novartis Investigative Site
  • Berlin, Germany, 14165
    • Novartis Investigative Site
  • Berlin, Germany, 12351
    • Novartis Investigative Site
  • Chemnitz, Germany, 09113
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Erfurt, Germany, 99089
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Georgsmarienhuette, Germany, 49124
    • Novartis Investigative Site
  • Gera, Germany, 07548
    • Novartis Investigative Site
  • Gerlingen, Germany, 70839
    • Novartis Investigative Site
  • Grosshansdorf, Germany, 22947
    • Novartis Investigative Site
  • Halle (Saale), Germany, 06120
    • Novartis Investigative Site
  • Koeln, Germany, 51109
    • Novartis Investigative Site
  • Leipzig, Germany, D-04347
    • Novartis Investigative Site
  • Minden, Germany, 32429
    • Novartis Investigative Site
  • Muenchen, Germany, 81377
    • Novartis Investigative Site
  • Nuernberg, Germany, 90419
    • Novartis Investigative Site
  • Solingen, Germany, 42699
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Novartis Investigative Site
  • Wuerzburg, Germany, 97074
    • Novartis Investigative Site
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • Novartis Investigative Site
  • Bayern
    • Gauting, Bayern, Germany, 82131
      • Novartis Investigative Site
  • Nordrhein Westfalen
    • Bochum, Nordrhein Westfalen, Germany, 44791
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Velbert, North Rhine-Westphalia, Germany, 42551
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 18547
    • Novartis Investigative Site
  • Athens, Greece, 11526
    • Novartis Investigative Site
  • Athens, Greece, GR14564
    • Novartis Investigative Site
  • Thessaloniki, Greece, 57001
    • Novartis Investigative Site
  • Attica
    • Athens, Attica, Greece, 15562
      • Novartis Investigative Site
  • GR
    • Athens, GR, Greece, 115 27
      • Novartis Investigative Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Novartis Investigative Site
  • Kowloon, Hong Kong
    • Novartis Investigative Site
  • Tuen Mun, Hong Kong, 999077
    • Novartis Investigative Site
• Hungary
  • Veszprem, Hungary, 8200
    • Novartis Investigative Site
  • Pest
    • Torokbalint, Pest, Hungary, 2045
      • Novartis Investigative Site
• Iceland
  • Reykjavik, Iceland, IS-101
    • Novartis Investigative Site
• India
  • Delhi, India, 110 085
    • Novartis Investigative Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400022
      • Novartis Investigative Site
    • Nashik, Maharashtra, India, 422 004
      • Novartis Investigative Site
  • West Bengal
    • Kolkata, West Bengal, India, 700160
      • Novartis Investigative Site
• Israel
  • Haifa, Israel, 3109601
    • Novartis Investigative Site
  • Holon, Israel, 58100
    • Novartis Investigative Site
• Italy
  • AN
    • Ancona, AN, Italy, 60126
      • Novartis Investigative Site
  • BA
    • Bari, BA, Italy, 70124
      • Novartis Investigative Site
  • FC
    • Meldola, FC, Italy, 47014
      • Novartis Investigative Site
  • MB
    • Monza, MB, Italy, 20900
      • Novartis Investigative Site
  • MI
    • Milano, MI, Italy, 20133
      • Novartis Investigative Site
    • Milano, MI, Italy, 20132
      • Novartis Investigative Site
  • PD
    • Padova, PD, Italy, 35100
      • Novartis Investigative Site
  • PG
    • Perugia, PG, Italy, 06129
      • Novartis Investigative Site
  • PN
    • Aviano, PN, Italy, 33081
      • Novartis Investigative Site
  • RA
    • Ravenna, RA, Italy, 48100
      • Novartis Investigative Site
  • RM
    • Roma, RM, Italy, 00189
      • Novartis Investigative Site
  • TO
    • Orbassano, TO, Italy, 10043
      • Novartis Investigative Site
• Japan
  • Fukuoka, Japan, 810-8563
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Wakayama, Japan, 641-8510
    • Novartis Investigative Site
  • Aichi
    • Nagoya, Aichi, Japan, 466 8560
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 464 8681
      • Novartis Investigative Site
  • Aomori
    • Hirosaki, Aomori, Japan, 036 8563
      • Novartis Investigative Site
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Novartis Investigative Site
  • Fukuoka
    • Iizuka-city, Fukuoka, Japan, 820-8505
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa-city, Hokkaido, Japan, 070-8644
      • Novartis Investigative Site
    • Sapporo city, Hokkaido, Japan, 060 8648
      • Novartis Investigative Site
  • Hyogo
    • Himeji, Hyogo, Japan, 670-8520
      • Novartis Investigative Site
  • Ishikawa
    • Kanazawa-city, Ishikawa, Japan, 920-8641
      • Novartis Investigative Site
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama-city, Kanagawa, Japan, 241-8515
      • Novartis Investigative Site
    • Yokohama-city, Kanagawa, Japan, 236 0051
      • Novartis Investigative Site
  • Miyagi
    • Natori, Miyagi, Japan, 981-1293
      • Novartis Investigative Site
  • Osaka
    • Hirakata-city, Osaka, Japan, 573-1191
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 541-8567
      • Novartis Investigative Site
    • Sakai, Osaka, Japan, 591-8555
      • Novartis Investigative Site
  • Saitama
    • Hidaka-city, Saitama, Japan, 350-1298
      • Novartis Investigative Site
  • Shizuoka
    • Sunto Gun, Shizuoka, Japan, 411 8777
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo ku, Tokyo, Japan, 113-8431
      • Novartis Investigative Site
    • Chuo ku, Tokyo, Japan, 104 0045
      • Novartis Investigative Site
    • Minato ku, Tokyo, Japan, 105-8470
      • Novartis Investigative Site
  • Yamaguchi
    • Ube-city, Yamaguchi, Japan, 755-0241
      • Novartis Investigative Site
• Jordan
  • Amman, Jordan, 11941
    • Novartis Investigative Site
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03722
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 05505
    • Novartis Investigative Site
  • Chungcheongbuk Do
    • Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
      • Novartis Investigative Site
  • Korea
    • Jeollanam-do, Korea, Korea, Republic of, 58128
      • Novartis Investigative Site
    • Seoul, Korea, Korea, Republic of, 08308
      • Novartis Investigative Site
• Lebanon
  • Ashrafieh, Lebanon, 166830
    • Novartis Investigative Site
  • Beirut, Lebanon, 10999
    • Novartis Investigative Site
  • Saida, Lebanon, 652
    • Novartis Investigative Site
  • Tripoli, Lebanon, 1434
    • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Novartis Investigative Site
  • Pulau Pinang, Malaysia, 10990
    • Novartis Investigative Site
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Novartis Investigative Site
• Norway
  • Bergen, Norway, 5021
    • Novartis Investigative Site
  • Drammen, Norway, 3004
    • Novartis Investigative Site
  • Oslo, Norway, 0424
    • Novartis Investigative Site
  • Tromso, Norway, 9019
    • Novartis Investigative Site
• Panama
  • Panama City, Panama, 0801
    • Novartis Investigative Site
• Peru
  • Lima
    • San Borja, Lima, Peru, 41
      • Novartis Investigative Site
    • Surquillo, Lima, Peru, 34
      • Novartis Investigative Site
• Philippines
  • Makati City, Philippines, 1229
    • Novartis Investigative Site
• Poland
  • Konin, Poland, 62 500
    • Novartis Investigative Site
  • Olsztyn, Poland, 10-288
    • Novartis Investigative Site
  • Poznan, Poland, 60-693
    • Novartis Investigative Site
  • Rzeszow, Poland, 35-021
    • Novartis Investigative Site
  • Warszawa, Poland, 02 781
    • Novartis Investigative Site
  • Ma3opolska
    • Krakow, Ma3opolska, Poland, 31-826
      • Novartis Investigative Site
• Portugal
  • Lisboa, Portugal, 1769-001
    • Novartis Investigative Site
  • Matosinhos, Portugal, 4454 513
    • Novartis Investigative Site
  • Porto, Portugal, 4100-180
    • Novartis Investigative Site
• Romania
  • Bucuresti, Romania, 010991
    • Novartis Investigative Site
  • Cluj-Napoca, Romania, 400124
    • Novartis Investigative Site
  • Iasi, Romania, 700483
    • Novartis Investigative Site
  • Cluj
    • Floresti, Cluj, Romania, 407280
      • Novartis Investigative Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Novartis Investigative Site
  • Kaliningrad, Russian Federation, 236006
    • Novartis Investigative Site
  • Moscow Region Istra Village, Russian Federation, 143423
    • Novartis Investigative Site
  • Obninsk, Russian Federation, 249036
    • Novartis Investigative Site
  • Omsk, Russian Federation, 644013
    • Novartis Investigative Site
  • Pushkin Saint Petersburg, Russian Federation, 196603
    • Novartis Investigative Site
  • Ryazan, Russian Federation, 390011
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 197758
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 192148
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150054
    • Novartis Investigative Site
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28006
    • Novartis Investigative Site
  • Madrid, Spain, 28009
    • Novartis Investigative Site
  • Andalucia
    • Cordoba, Andalucia, Spain, 14004
      • Novartis Investigative Site
    • Sevilla, Andalucia, Spain, 41013
      • Novartis Investigative Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Novartis Investigative Site
  • Catalunya
    • Badalona, Catalunya, Spain, 08916
      • Novartis Investigative Site
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
    • Hospitalet de LLobregat, Catalunya, Spain, 08907
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Novartis Investigative Site
  • Galicia
    • Santiago De Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Novartis Investigative Site
• Switzerland
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • Fribourg, Switzerland, 1708
    • Novartis Investigative Site
  • Geneve 14, Switzerland, CH 1211
    • Novartis Investigative Site
• Taiwan
  • Changhua, Taiwan, 50006
    • Novartis Investigative Site
  • Hualien, Taiwan, 970
    • Novartis Investigative Site
  • Kaohsiung, Taiwan, 82445
    • Novartis Investigative Site
  • Kaohsiung, Taiwan, 83301
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taichung, Taiwan, 40705
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
  • Taipei, Taiwan, 11217
    • Novartis Investigative Site
  • Taoyuan, Taiwan, 33305
    • Novartis Investigative Site
  • Taiwan ROC
    • Taichung, Taiwan ROC, Taiwan, 40201
      • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10330
    • Novartis Investigative Site
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Bangkok, Thailand, 10300
    • Novartis Investigative Site
  • Chaingmai, Thailand, 50200
    • Novartis Investigative Site
  • Hat Yai
    • Songkhla, Hat Yai, Thailand, 90110
      • Novartis Investigative Site
  • THA
    • Khon Kaen, THA, Thailand, 40002
      • Novartis Investigative Site
• Turkey
  • Adana, Turkey, 01250
    • Novartis Investigative Site
  • Istanbul, Turkey, 34303
    • Novartis Investigative Site
  • Izmir, Turkey, 35575
    • Novartis Investigative Site
  • Pendik Istanbul, Turkey, 34899
    • Novartis Investigative Site
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06200
      • Novartis Investigative Site
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS2 8HN
    • Novartis Investigative Site
  • Leicester, United Kingdom, LE1 5WW
    • Novartis Investigative Site
  • London, United Kingdom, NW3 2QG
    • Novartis Investigative Site
  • London, United Kingdom, EC14 7BE
    • Novartis Investigative Site
  • Nottingham, United Kingdom, NG5 1PB
    • Novartis Investigative Site
  • Oxford, United Kingdom, OX3 7LJ
    • Novartis Investigative Site
  • Preston, United Kingdom, PR2 9HT
    • Novartis Investigative Site
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Novartis Investigative Site
  • Cambrigdeshire
    • Cambridge, Cambrigdeshire, United Kingdom, CB2 0QQ
      • Novartis Investigative Site
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Novartis Investigative Site
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
      • Novartis Investigative Site
  • Merseyside
    • Wirral, Merseyside, United Kingdom, CH63 4JY
      • Novartis Investigative Site
  • Suffolk
    • Ipswich, Suffolk, United Kingdom, IP4 5PD
      • Novartis Investigative Site
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
      • Novartis Investigative Site
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group .
  • California
    • Los Alamitos, California, United States, 90720
      • Cancer and Blood Specialty Clinic
    • Los Angeles, California, United States, 90095
      • University of California at Los Angeles
    • Palo Alto, California, United States, 94304-1207
      • VA Palo Alto Health Care System CRLX030A2301
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
  • Colorado
    • Longmont, Colorado, United States, 80501
      • Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Miami, Florida, United States, 33176
      • Advanced Medical Specialties Drug Ship - 2
    • Ocala, Florida, United States, 34474
      • Florida Cancer Affiliates of Ocala
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists North
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center Regulatory
  • Kansas
    • Wichita, Kansas, United States, 67214-3728
      • Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • VA Nebraska-W IA Health Care System .
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Louis Stokes Cleveland Department of Veterans Affairs MC .
  • Oregon
    • Eugene, Oregon, United States, 97401-8122
      • Oncology Associates of Oregon, PC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology MamieMcFaddenWardCtr
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists Fairfax Northern Virginia
    • Salem, Virginia, United States, 24153
      • Oncology and Hematology Associates of Southwest Virginia Inc .
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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)
• 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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: canakinumab; Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Drug: 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.; Other Names: ACZ885
Placebo Comparator: Placebo; Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%.	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.	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.	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%.	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.	Up to approximately 4 years
Canakinumab Serum Concentrations	Serum concentrations of canakinumab were determinded using an ELISA method.	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	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)	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.	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.	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.	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.	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)	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.

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; adjuvant; ACZ885; canakinumab; AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CACZ885T2301; 2017-004011-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No