Lung Cancer Clinical Trial
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
Summary
The primary purpose of the study is to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion Criteria:
Have completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR have NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and are candidates for complete resection surgery
Cisplatin-based chemotherapy is mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy can be administered if recommended by the treating physician). When required, a minimum of two cycles of cisplatin-based chemotherapy is mandatory, after which additional therapies can be given based upon local clinical practice and/or guidelines. Typically, chemotherapy is initiated within 60 days of surgery.
Must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1 (CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy are allowed to enter the study
Have ECOG performance status (PS) of 0 or 1
Exclusion Criteria:
Have unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
Have received any neoadjuvant therapy
Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion include 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.
Have a history of current diagnosis of cardiac disease
Have uncontrolled diabetes
Have known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible.
Have 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.).
Other inclusion/exclusion criteria may apply
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There are 275 Locations for this study
Fayetteville Arkansas, 72703, United States
Los Alamitos California, 90720, United States
Los Angeles California, 90095, United States
Palo Alto California, 94304, United States
Santa Barbara California, 93105, United States
Longmont Colorado, 80501, United States
Fort Myers Florida, 33901, United States
Miami Florida, 33176, United States
Ocala Florida, 34471, United States
Saint Petersburg Florida, 33705, United States
Tallahassee Florida, 32308, United States
West Palm Beach Florida, 33401, United States
Chicago Illinois, 60612, United States
Wichita Kansas, 67214, United States
Omaha Nebraska, 68105, United States
Cleveland Ohio, 44106, United States
Eugene Oregon, 97401, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75216, United States
Dallas Texas, 75246, United States
Fairfax Virginia, 22031, United States
Salem Virginia, 24153, United States
Caba Buenos Aires, C1426, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
Rosario Santa Fe, S2000, Argentina
Rosario Sante Fe, S200K, Argentina
Cordoba , X5016, Argentina
Graz , 8036, Austria
Klagenfurt , 9020, Austria
Krems , A-350, Austria
Vienna , A-109, Austria
Teresina Piaui, 64049, Brazil
Londrina PR, 86015, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Sao Paulo SP, 04014, Brazil
Sofia , 1303, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1756, Bulgaria
Sofia , 1784, Bulgaria
Edmonton Alberta, T6G 1, Canada
Moncton New Brunswick, E1C 6, Canada
Halifax Nova Scotia, B3H 1, Canada
Montreal Quebec, H2W 1, Canada
Quebec , GIV 4, Canada
Santiago , 75009, Chile
Santiago , , Chile
Hefei Anhui, 23000, China
Beijing Beijing, 10003, China
Chongqing Chongqing, 40003, China
Guangzhou Guangdong, 51000, China
Shenzhen Guangdong, 51802, China
Zhanjing Guangong, 52400, China
Zunyi Guizhou, , China
Zhengzhou Henan, 45000, China
Nanjing Jiangsu, 21000, China
Suzhou Jiangsu, 21500, China
Chang Chun Jilin, 13002, China
Shenyang Liaoning, 11001, China
Jinan Shandong, 25011, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20043, China
XI An Shanxi, 71006, China
Shenyang Shengyang, 11004, China
Chengdu Sichuan, 61004, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Beijing , 10003, China
Changsha , 41001, China
Chengdu , , China
Fujian , 35000, China
Tianjin , 30000, China
Tianjin , 30005, China
Bogota , 11022, Colombia
Ostrava Vitkovice , 703 8, Czechia
Prague 2 , 128 2, Czechia
Marseille cedex 20 Bouches Du Rhone, 13915, France
Le Mans Cedex 09, 72037, France
Montpellier cedex 5 Herault, 34059, France
Amiens , 80054, France
Angers Cedex 9 , 49933, France
Avignon Cedex , 84902, France
Bayonne , 64109, France
Brest , 29200, France
Bron , 69677, France
Clermont-Ferrand , 63000, France
Creteil , 94000, France
La Rochelle , 17019, France
La Seyne sur mer , 83500, France
Lille , 59000, France
Paris , 75231, France
Paris , 75679, France
Pessac , 33604, France
Poitiers , 86000, France
Saint-Herblain Cédex , 44805, France
Strasbourg Cedex , 67091, France
Suresnes , 92150, France
Toulouse , 31400, France
Batumi , 6000, Georgia
Tbilisi , 0144, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 112, Georgia
Heidelberg Baden-Württemberg, 69126, Germany
Gauting Bayern, 82131, Germany
Bochum Nordrhein Westfalen, 44791, Germany
Velbert North Rhine-westphalia, 42551, Germany
Aachen , 52074, Germany
Berlin , 12351, Germany
Berlin , 13125, Germany
Berlin , 14165, Germany
Chemnitz , 09113, Germany
Dresden , 01307, Germany
Erfurt , 99089, Germany
Essen , 45147, Germany
Georgsmarienhuette , 49124, Germany
Gera , 07548, Germany
Gerlingen , 70839, Germany
Grosshansdorf , 22947, Germany
Halle (Saale) , 06120, Germany
Koeln , 51109, Germany
Leipzig , D-043, Germany
Minden , 32429, Germany
Muenchen , 81377, Germany
Nuernberg , 90419, Germany
Solingen , 42699, Germany
Ulm , 89081, Germany
Wuerzburg , 97074, Germany
Athens Attica, 15562, Greece
Athens GR, 115 2, Greece
Athens , 11526, Greece
Athens , 18547, Greece
Athens , GR145, Greece
Thessaloniki , 57001, Greece
Hong Kong , , Hong Kong
Kowloon , , Hong Kong
Tuen Mun , , Hong Kong
Torokbalint Pest, 2045, Hungary
Veszprem , 8200, Hungary
Reykjavik , IS-10, Iceland
Mumbai Maharashtra, 40002, India
Nashik Maharashtra, 422 0, India
Kolkata West Bengal, 70016, India
Delhi , 110 0, India
Haifa , 31096, Israel
Holon , 58100, Israel
Ancona AN, 60126, Italy
Bari BA, 70124, Italy
Meldola FC, 47014, Italy
Monza MB, 20900, Italy
Milano MI, 20132, Italy
Milano MI, 20133, Italy
Padova PD, 35100, Italy
Perugia PG, 06129, Italy
Aviano PN, 33081, Italy
Ravenna RA, 48100, Italy
Roma RM, 00189, Italy
Orbassano TO, 10043, Italy
Nagoya Aichi, 464 8, Japan
Nagoya Aichi, 466 8, Japan
Hirosaki Aomori, 036 8, Japan
Matsuyama Ehime, 791-0, Japan
Iizuka-city Fukuoka, 820-8, Japan
Asahikawa-city Hokkaido, 070-8, Japan
Sapporo city Hokkaido, 060 8, Japan
Himeji Hyogo, 670-8, Japan
Kanazawa-city Ishikawa, 920-8, Japan
Shiwa-gun Iwate, 028-3, Japan
Yokohama-city Kanagawa, 236 0, Japan
Yokohama-city Kanagawa, 241-8, Japan
Natori Miyagi, 981-1, Japan
Hirakata-city Osaka, 573-1, Japan
Osaka-city Osaka, 541-8, Japan
Sakai Osaka, 591-8, Japan
Hidaka-city Saitama, 350-1, Japan
Sunto Gun Shizuoka, 411 8, Japan
Bunkyo ku Tokyo, 113-8, Japan
Chuo ku Tokyo, 104 0, Japan
Minato ku Tokyo, 105-8, Japan
Wakayama-city Wakayama, 641-8, Japan
Ube-city Yamaguchi, 755-0, Japan
Fukuoka , 810-8, Japan
Osaka , 545-8, Japan
Amman , 11941, Jordan
Cheongju si Chungcheongbuk Do, 28644, Korea, Republic of
Jeollanam-do Korea, 58128, Korea, Republic of
Seoul Korea, 08308, Korea, Republic of
Busan , 48108, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Ashrafieh , 16683, Lebanon
Beirut , , Lebanon
Saida , 652, Lebanon
Tripoli , 1434, Lebanon
Kuching Sarawak, 93586, Malaysia
Kuala Lumpur , 59100, Malaysia
Pulau Pinang , 10990, Malaysia
Bergen , 5021, Norway
Drammen , 3004, Norway
Oslo , 0424, Norway
Tromso , 9019, Norway
Panama City , 0801, Panama
San Borja Lima, 41, Peru
Surquillo Lima, 34, Peru
Makati City , 1229, Philippines
Krakow Ma3opolska, 31-82, Poland
Konin , 62 50, Poland
Olsztyn , 10-28, Poland
Poznan , 60-69, Poland
Rzeszow , 35-02, Poland
Warszawa , 02 78, Poland
Lisboa , 1769-, Portugal
Matosinhos , 4454 , Portugal
Porto , 4100-, Portugal
Floresti Cluj, 40728, Romania
Bucuresti , 01099, Romania
Cluj-Napoca , 40012, Romania
Iasi , 70048, Romania
Arkhangelsk , 16304, Russian Federation
Kaliningrad , 23600, Russian Federation
Moscow , 14342, Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Pushkin Saint Petersburg , 19660, Russian Federation
Ryazan , 39001, Russian Federation
Saint Petersburg , 19702, Russian Federation
St Petersburg , 19214, Russian Federation
St Petersburg , 19775, Russian Federation
Yaroslavl , 15005, Russian Federation
Ljubljana , 1000, Slovenia
Cordoba Andalucia, 14004, Spain
Sevilla Andalucia, 41013, Spain
Santander Cantabria, 39008, Spain
Badalona Catalunya, 08916, Spain
Barcelona Catalunya, 08036, Spain
Hospitalet de LLobregat Catalunya, 08907, Spain
Valencia Comunidad Valenciana, 46010, Spain
Santiago de Compostela Galicia, 15706, Spain
La Laguna Santa Cruz De Tenerife, 38320, Spain
Madrid , 28006, Spain
Madrid , 28009, Spain
Madrid , 28041, Spain
Bern , 3010, Switzerland
Fribourg , 1708, Switzerland
Geneve 14 , CH 12, Switzerland
Taichung Taiwan ROC, 40201, Taiwan
Changhua , 50006, Taiwan
Hualien , 970, Taiwan
Kaohsiung City , 83301, Taiwan
Kaohsiung , 82445, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 33305, Taiwan
Songkhla Hat Yai, 90110, Thailand
Khon Kaen THA, 40002, Thailand
Bangkok , 10300, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Chaingmai , 50200, Thailand
Ankara Yenimahalle, 06200, Turkey
Adana , 01250, Turkey
Istanbul , 34303, Turkey
Izmir , , Turkey
Pendik / Istanbul , 34899, Turkey
Cambridge Cambrigdeshire, CB2 0, United Kingdom
Truro Cornwall, TR1 3, United Kingdom
Cheltenham Gloucestershire, GL53 , United Kingdom
Wirral Merseyside, CH63 , United Kingdom
Ipswich Suffolk, IP4 5, United Kingdom
Guildford Surrey, GU2 7, United Kingdom
Birmingham , B9 5S, United Kingdom
Bristol , BS2 8, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC14 , United Kingdom
London , NW3 2, United Kingdom
Nottingham , NG5 1, United Kingdom
Oxford , OX3 7, United Kingdom
Preston , PR2 9, United Kingdom
Stoke-on-Trent , ST4 6, United Kingdom
Hanoi , 10000, Vietnam
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