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).

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1382

Study ID:

NCT03447769

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 275 Locations for this study

See Locations Near You

Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Cancer and Blood Specialty Clinic
Los Alamitos California, 90720, United States
University of California at Los Angeles
Los Angeles California, 90095, United States
VA Palo Alto Health Care System CRLX030A2301
Palo Alto California, 94304, United States
Sansum Clinic
Santa Barbara California, 93105, United States
Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)
Longmont Colorado, 80501, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Advanced Medical Specialties Drug Ship - 2
Miami Florida, 33176, United States
Florida Cancer Affiliates of Ocala
Ocala Florida, 34471, United States
Florida Cancer Specialists North
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists Panhandle
Tallahassee Florida, 32308, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Rush University Medical Center CLDT600AUS06
Chicago Illinois, 60612, United States
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
Wichita Kansas, 67214, United States
VA Nebraska-Western Iowa Health Care System
Omaha Nebraska, 68105, United States
Louis Stokes Cleveland Department of Veterans Affairs MC
Cleveland Ohio, 44106, United States
Oncology Associates of Oregon, PC
Eugene Oregon, 97401, United States
Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology
Chattanooga Tennessee, 37404, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
VA North Texas Health Care System
Dallas Texas, 75216, United States
Texas Oncology MamieMcFaddenWardCtr
Dallas Texas, 75246, United States
Virginia Cancer Specialists Fairfax Northern Virginia
Fairfax Virginia, 22031, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Salem Virginia, 24153, United States
Novartis Investigative Site
Caba Buenos Aires, C1426, Argentina
Novartis Investigative Site
Mar del Plata Buenos Aires, B7600, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
Novartis Investigative Site
Rosario Sante Fe, S200K, Argentina
Novartis Investigative Site
Cordoba , X5016, Argentina
Novartis Investigative Site
Graz , 8036, Austria
Novartis Investigative Site
Klagenfurt , 9020, Austria
Novartis Investigative Site
Krems , A-350, Austria
Novartis Investigative Site
Vienna , A-109, Austria
Novartis Investigative Site
Teresina Piaui, 64049, Brazil
Novartis Investigative Site
Londrina PR, 86015, Brazil
Novartis Investigative Site
Barretos SP, 14784, Brazil
Novartis Investigative Site
Sao Paulo SP, 01246, Brazil
Novartis Investigative Site
Sao Paulo SP, 04014, Brazil
Novartis Investigative Site
Sofia , 1303, Bulgaria
Novartis Investigative Site
Sofia , 1407, Bulgaria
Novartis Investigative Site
Sofia , 1756, Bulgaria
Novartis Investigative Site
Sofia , 1784, Bulgaria
Novartis Investigative Site
Edmonton Alberta, T6G 1, Canada
Novartis Investigative Site
Moncton New Brunswick, E1C 6, Canada
Novartis Investigative Site
Halifax Nova Scotia, B3H 1, Canada
Novartis Investigative Site
Montreal Quebec, H2W 1, Canada
Novartis Investigative Site
Quebec , GIV 4, Canada
Novartis Investigative Site
Santiago , 75009, Chile
Novartis Investigative Site
Santiago , , Chile
Novartis Investigative Site
Hefei Anhui, 23000, China
Novartis Investigative Site
Beijing Beijing, 10003, China
Novartis Investigative Site
Chongqing Chongqing, 40003, China
Novartis Investigative Site
Guangzhou Guangdong, 51000, China
Novartis Investigative Site
Shenzhen Guangdong, 51802, China
Novartis Investigative Site
Zhanjing Guangong, 52400, China
Novartis Investigative Site
Zunyi Guizhou, , China
Novartis Investigative Site
Zhengzhou Henan, 45000, China
Novartis Investigative Site
Nanjing Jiangsu, 21000, China
Novartis Investigative Site
Suzhou Jiangsu, 21500, China
Novartis Investigative Site
Chang Chun Jilin, 13002, China
Novartis Investigative Site
Shenyang Liaoning, 11001, China
Novartis Investigative Site
Jinan Shandong, 25011, China
Novartis Investigative Site
Shanghai Shanghai, 20003, China
Novartis Investigative Site
Shanghai Shanghai, 20043, China
Novartis Investigative Site
XI An Shanxi, 71006, China
Novartis Investigative Site
Shenyang Shengyang, 11004, China
Novartis Investigative Site
Chengdu Sichuan, 61004, China
Novartis Investigative Site
Hangzhou Zhejiang, 31000, China
Novartis Investigative Site
Hangzhou Zhejiang, 31002, China
Novartis Investigative Site
Beijing , 10003, China
Novartis Investigative Site
Changsha , 41001, China
Novartis Investigative Site
Chengdu , , China
Novartis Investigative Site
Fujian , 35000, China
Novartis Investigative Site
Tianjin , 30000, China
Novartis Investigative Site
Tianjin , 30005, China
Novartis Investigative Site
Bogota , 11022, Colombia
Novartis Investigative Site
Ostrava Vitkovice , 703 8, Czechia
Novartis Investigative Site
Prague 2 , 128 2, Czechia
Novartis Investigative Site
Marseille cedex 20 Bouches Du Rhone, 13915, France
Novartis Investigative Site
Le Mans Cedex 09, 72037, France
Novartis Investigative Site
Montpellier cedex 5 Herault, 34059, France
Novartis Investigative Site
Amiens , 80054, France
Novartis Investigative Site
Angers Cedex 9 , 49933, France
Novartis Investigative Site
Avignon Cedex , 84902, France
Novartis Investigative Site
Bayonne , 64109, France
Novartis Investigative Site
Brest , 29200, France
Novartis Investigative Site
Bron , 69677, France
Novartis Investigative Site
Clermont-Ferrand , 63000, France
Novartis Investigative Site
Creteil , 94000, France
Novartis Investigative Site
La Rochelle , 17019, France
Novartis Investigative Site
La Seyne sur mer , 83500, France
Novartis Investigative Site
Lille , 59000, France
Novartis Investigative Site
Paris , 75231, France
Novartis Investigative Site
Paris , 75679, France
Novartis Investigative Site
Pessac , 33604, France
Novartis Investigative Site
Poitiers , 86000, France
Novartis Investigative Site
Saint-Herblain Cédex , 44805, France
Novartis Investigative Site
Strasbourg Cedex , 67091, France
Novartis Investigative Site
Suresnes , 92150, France
Novartis Investigative Site
Toulouse , 31400, France
Novartis Investigative Site
Batumi , 6000, Georgia
Novartis Investigative Site
Tbilisi , 0144, Georgia
Novartis Investigative Site
Tbilisi , 0159, Georgia
Novartis Investigative Site
Tbilisi , 0160, Georgia
Novartis Investigative Site
Tbilisi , 112, Georgia
Novartis Investigative Site
Heidelberg Baden-Württemberg, 69126, Germany
Novartis Investigative Site
Gauting Bayern, 82131, Germany
Novartis Investigative Site
Bochum Nordrhein Westfalen, 44791, Germany
Novartis Investigative Site
Velbert North Rhine-westphalia, 42551, Germany
Novartis Investigative Site
Aachen , 52074, Germany
Novartis Investigative Site
Berlin , 12351, Germany
Novartis Investigative Site
Berlin , 13125, Germany
Novartis Investigative Site
Berlin , 14165, Germany
Novartis Investigative Site
Chemnitz , 09113, Germany
Novartis Investigative Site
Dresden , 01307, Germany
Novartis Investigative Site
Erfurt , 99089, Germany
Novartis Investigative Site
Essen , 45147, Germany
Novartis Investigative Site
Georgsmarienhuette , 49124, Germany
Novartis Investigative Site
Gera , 07548, Germany
Novartis Investigative Site
Gerlingen , 70839, Germany
Novartis Investigative Site
Grosshansdorf , 22947, Germany
Novartis Investigative Site
Halle (Saale) , 06120, Germany
Novartis Investigative Site
Koeln , 51109, Germany
Novartis Investigative Site
Leipzig , D-043, Germany
Novartis Investigative Site
Minden , 32429, Germany
Novartis Investigative Site
Muenchen , 81377, Germany
Novartis Investigative Site
Nuernberg , 90419, Germany
Novartis Investigative Site
Solingen , 42699, Germany
Novartis Investigative Site
Ulm , 89081, Germany
Novartis Investigative Site
Wuerzburg , 97074, Germany
Novartis Investigative Site
Athens Attica, 15562, Greece
Novartis Investigative Site
Athens GR, 115 2, Greece
Novartis Investigative Site
Athens , 11526, Greece
Novartis Investigative Site
Athens , 18547, Greece
Novartis Investigative Site
Athens , GR145, Greece
Novartis Investigative Site
Thessaloniki , 57001, Greece
Novartis Investigative Site
Hong Kong , , Hong Kong
Novartis Investigative Site
Kowloon , , Hong Kong
Novartis Investigative Site
Tuen Mun , , Hong Kong
Novartis Investigative Site
Torokbalint Pest, 2045, Hungary
Novartis Investigative Site
Veszprem , 8200, Hungary
Novartis Investigative Site
Reykjavik , IS-10, Iceland
Novartis Investigative Site
Mumbai Maharashtra, 40002, India
Novartis Investigative Site
Nashik Maharashtra, 422 0, India
Novartis Investigative Site
Kolkata West Bengal, 70016, India
Novartis Investigative Site
Delhi , 110 0, India
Novartis Investigative Site
Haifa , 31096, Israel
Novartis Investigative Site
Holon , 58100, Israel
Novartis Investigative Site
Ancona AN, 60126, Italy
Novartis Investigative Site
Bari BA, 70124, Italy
Novartis Investigative Site
Meldola FC, 47014, Italy
Novartis Investigative Site
Monza MB, 20900, Italy
Novartis Investigative Site
Milano MI, 20132, Italy
Novartis Investigative Site
Milano MI, 20133, Italy
Novartis Investigative Site
Padova PD, 35100, Italy
Novartis Investigative Site
Perugia PG, 06129, Italy
Novartis Investigative Site
Aviano PN, 33081, Italy
Novartis Investigative Site
Ravenna RA, 48100, Italy
Novartis Investigative Site
Roma RM, 00189, Italy
Novartis Investigative Site
Orbassano TO, 10043, Italy
Novartis Investigative Site
Nagoya Aichi, 464 8, Japan
Novartis Investigative Site
Nagoya Aichi, 466 8, Japan
Novartis Investigative Site
Hirosaki Aomori, 036 8, Japan
Novartis Investigative Site
Matsuyama Ehime, 791-0, Japan
Novartis Investigative Site
Iizuka-city Fukuoka, 820-8, Japan
Novartis Investigative Site
Asahikawa-city Hokkaido, 070-8, Japan
Novartis Investigative Site
Sapporo city Hokkaido, 060 8, Japan
Novartis Investigative Site
Himeji Hyogo, 670-8, Japan
Novartis Investigative Site
Kanazawa-city Ishikawa, 920-8, Japan
Novartis Investigative Site
Shiwa-gun Iwate, 028-3, Japan
Novartis Investigative Site
Yokohama-city Kanagawa, 236 0, Japan
Novartis Investigative Site
Yokohama-city Kanagawa, 241-8, Japan
Novartis Investigative Site
Natori Miyagi, 981-1, Japan
Novartis Investigative Site
Hirakata-city Osaka, 573-1, Japan
Novartis Investigative Site
Osaka-city Osaka, 541-8, Japan
Novartis Investigative Site
Sakai Osaka, 591-8, Japan
Novartis Investigative Site
Hidaka-city Saitama, 350-1, Japan
Novartis Investigative Site
Sunto Gun Shizuoka, 411 8, Japan
Novartis Investigative Site
Bunkyo ku Tokyo, 113-8, Japan
Novartis Investigative Site
Chuo ku Tokyo, 104 0, Japan
Novartis Investigative Site
Minato ku Tokyo, 105-8, Japan
Novartis Investigative Site
Wakayama-city Wakayama, 641-8, Japan
Novartis Investigative Site
Ube-city Yamaguchi, 755-0, Japan
Novartis Investigative Site
Fukuoka , 810-8, Japan
Novartis Investigative Site
Osaka , 545-8, Japan
Novartis Investigative Site
Amman , 11941, Jordan
Novartis Investigative Site
Cheongju si Chungcheongbuk Do, 28644, Korea, Republic of
Novartis Investigative Site
Jeollanam-do Korea, 58128, Korea, Republic of
Novartis Investigative Site
Seoul Korea, 08308, Korea, Republic of
Novartis Investigative Site
Busan , 48108, Korea, Republic of
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Seoul , 03722, Korea, Republic of
Novartis Investigative Site
Seoul , 05505, Korea, Republic of
Novartis Investigative Site
Ashrafieh , 16683, Lebanon
Novartis Investigative Site
Beirut , , Lebanon
Novartis Investigative Site
Saida , 652, Lebanon
Novartis Investigative Site
Tripoli , 1434, Lebanon
Novartis Investigative Site
Kuching Sarawak, 93586, Malaysia
Novartis Investigative Site
Kuala Lumpur , 59100, Malaysia
Novartis Investigative Site
Pulau Pinang , 10990, Malaysia
Novartis Investigative Site
Bergen , 5021, Norway
Novartis Investigative Site
Drammen , 3004, Norway
Novartis Investigative Site
Oslo , 0424, Norway
Novartis Investigative Site
Tromsø , 9038, Norway
Novartis Investigative Site
Panama City , 0801, Panama
Novartis Investigative Site
San Borja Lima, 41, Peru
Novartis Investigative Site
Surquillo Lima, 34, Peru
Novartis Investigative Site
Makati City , 1229, Philippines
Novartis Investigative Site
Krakow Ma3opolska, 31-82, Poland
Novartis Investigative Site
Konin , 62 50, Poland
Novartis Investigative Site
Olsztyn , 10-28, Poland
Novartis Investigative Site
Poznan , 60-69, Poland
Novartis Investigative Site
Rzeszow , 35-02, Poland
Novartis Investigative Site
Warszawa , 02 78, Poland
Novartis Investigative Site
Lisboa , 1769-, Portugal
Novartis Investigative Site
Matosinhos , 4454 , Portugal
Novartis Investigative Site
Porto , 4100-, Portugal
Novartis Investigative Site
Floresti Cluj, 40728, Romania
Novartis Investigative Site
Bucuresti , 01099, Romania
Novartis Investigative Site
Cluj-Napoca , 40012, Romania
Novartis Investigative Site
Iasi , 70048, Romania
Novartis Investigative Site
Arkhangelsk , 16304, Russian Federation
Novartis Investigative Site
Kaliningrad , 23600, Russian Federation
Novartis Investigative Site
Moscow , 14342, Russian Federation
Novartis Investigative Site
Obninsk , 24903, Russian Federation
Novartis Investigative Site
Omsk , 64401, Russian Federation
Novartis Investigative Site
Pushkin Saint Petersburg , 19660, Russian Federation
Novartis Investigative Site
Ryazan , 39001, Russian Federation
Novartis Investigative Site
Saint Petersburg , 19702, Russian Federation
Novartis Investigative Site
St Petersburg , 19214, Russian Federation
Novartis Investigative Site
St Petersburg , 19775, Russian Federation
Novartis Investigative Site
Yaroslavl , 15005, Russian Federation
Novartis Investigative Site
Ljubljana , 1000, Slovenia
Novartis Investigative Site
Cordoba Andalucia, 14004, Spain
Novartis Investigative Site
Sevilla Andalucia, 41013, Spain
Novartis Investigative Site
Santander Cantabria, 39008, Spain
Novartis Investigative Site
Badalona Catalunya, 08916, Spain
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Hospitalet de LLobregat Catalunya, 08907, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
Santiago de Compostela Galicia, 15706, Spain
Novartis Investigative Site
La Laguna Santa Cruz De Tenerife, 38320, Spain
Novartis Investigative Site
Madrid , 28006, Spain
Novartis Investigative Site
Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28041, Spain
Novartis Investigative Site
Bern , 3010, Switzerland
Novartis Investigative Site
Fribourg , 1708, Switzerland
Novartis Investigative Site
Geneve 14 , CH 12, Switzerland
Novartis Investigative Site
Taichung Taiwan ROC, 40201, Taiwan
Novartis Investigative Site
Changhua , 50006, Taiwan
Novartis Investigative Site
Hualien , 970, Taiwan
Novartis Investigative Site
Kaohsiung City , 83301, Taiwan
Novartis Investigative Site
Kaohsiung , 82445, Taiwan
Novartis Investigative Site
Taichung , 40447, Taiwan
Novartis Investigative Site
Taichung , 40705, Taiwan
Novartis Investigative Site
Taipei , 10002, Taiwan
Novartis Investigative Site
Taipei , 11217, Taiwan
Novartis Investigative Site
Taoyuan , 33305, Taiwan
Novartis Investigative Site
Songkhla Hat Yai, 90110, Thailand
Novartis Investigative Site
Khon Kaen THA, 40002, Thailand
Novartis Investigative Site
Bangkok , 10300, Thailand
Novartis Investigative Site
Bangkok , 10330, Thailand
Novartis Investigative Site
Bangkok , 10400, Thailand
Novartis Investigative Site
Bangkok , 10700, Thailand
Novartis Investigative Site
Chaingmai , 50200, Thailand
Novartis Investigative Site
Ankara Yenimahalle, 06200, Turkey
Novartis Investigative Site
Adana , 01250, Turkey
Novartis Investigative Site
Istanbul , 34303, Turkey
Novartis Investigative Site
Izmir , , Turkey
Novartis Investigative Site
Pendik / Istanbul , 34899, Turkey
Novartis Investigative Site
Cambridge Cambrigdeshire, CB2 0, United Kingdom
Novartis Investigative Site
Truro Cornwall, TR1 3, United Kingdom
Novartis Investigative Site
Cheltenham Gloucestershire, GL53 , United Kingdom
Novartis Investigative Site
Wirral Merseyside, CH63 , United Kingdom
Novartis Investigative Site
Ipswich Suffolk, IP4 5, United Kingdom
Novartis Investigative Site
Guildford Surrey, GU2 7, United Kingdom
Novartis Investigative Site
Birmingham , B9 5S, United Kingdom
Novartis Investigative Site
Bristol , BS2 8, United Kingdom
Novartis Investigative Site
Leicester , LE1 5, United Kingdom
Novartis Investigative Site
London , EC14 , United Kingdom
Novartis Investigative Site
London , NW3 2, United Kingdom
Novartis Investigative Site
Nottingham , NG5 1, United Kingdom
Novartis Investigative Site
Oxford , OX3 7, United Kingdom
Novartis Investigative Site
Preston , PR2 9, United Kingdom
Novartis Investigative Site
Stoke-on-Trent , ST4 6, United Kingdom
Novartis Investigative Site
Hanoi , 10000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1382

Study ID:

NCT03447769

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.