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 Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1382

Study ID:

NCT03447769

Recruitment Status:

Terminated

Sponsor:

Novartis Pharmaceuticals

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There are 278 Locations for this study

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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, 34474, United States
Florida Cancer Specialists North
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Rush University Medical Center Regulatory
Chicago Illinois, 60612, United States
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
Wichita Kansas, 67214, United States
VA Nebraska-W IA 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
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
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Caba Buenos Aires, C1426, Argentina
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Mar del Plata Buenos Aires, B7600, Argentina
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Rosario Santa Fe, S2000, Argentina
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Rosario Sante Fe, S200K, Argentina
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Cordoba , X5016, Argentina
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Graz , 8036, Austria
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Klagenfurt , 9020, Austria
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Krems , A-350, Austria
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Vienna , A 109, Austria
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Teresina Piaui, 64049, Brazil
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Londrina PR, 86015, Brazil
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Barretos SP, 14784, Brazil
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Sao Paulo SP, 01246, Brazil
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Sao Paulo SP, 04014, Brazil
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Sofia , 1303, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1756, Bulgaria
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Sofia , 1784, Bulgaria
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Edmonton Alberta, T6G 1, Canada
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Moncton New Brunswick, E1C 6, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Montreal Quebec, H2W 1, Canada
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Quebec , GIV 4, Canada
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Santiago , 75000, Chile
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Santiago , 75009, Chile
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Hefei Anhui, 23000, China
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Beijing Beijing, 10003, China
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Chongqing Chongqing, 40003, China
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Guangzhou Guangdong, 51000, China
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Shenzhen Guangdong, 51802, China
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Zhanjing Guangong, 52400, China
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Zunyi Guizhou, 56300, China
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Zhengzhou Henan, 45000, China
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Nanjing Jiangsu, 21000, China
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Suzhou Jiangsu, 21500, China
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Chang Chun Jilin, 13002, China
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Shenyang Liaoning, 11001, China
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Jinan Shandong, 25011, China
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Shanghai Shanghai, 20003, China
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Shanghai Shanghai, 20043, China
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XI An Shanxi, 71006, China
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Shenyang Shengyang, 11004, China
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Chengdu Sichuan, 61004, China
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Hangzhou Zhejiang, 31000, China
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Hangzhou Zhejiang, 31002, China
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Beijing , 10003, China
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Changsha , 41001, China
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Chengdu , 61004, China
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Fujian , 35000, China
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Tianjin , 30000, China
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Tianjin , 30005, China
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Bogota , 11022, Colombia
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Ostrava Vitkovice , 703 8, Czechia
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Prague 2 , 128 2, Czechia
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Marseille cedex 20 Bouches Du Rhone, 13915, France
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Le Mans Cedex 09, 72037, France
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Montpellier cedex 5 Herault, 34059, France
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Amiens , 80054, France
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Angers Cedex 9 , 49933, France
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Avignon Cedex , 84902, France
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Bayonne , 64109, France
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Brest , 29200, France
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Bron , 69677, France
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Clermont-Ferrand , 63000, France
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Creteil , 94000, France
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La Rochelle , 17019, France
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La Seyne sur mer , 83500, France
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Lille , 59000, France
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Paris , 75014, France
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Paris , 75231, France
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Pessac Cedex , 33604, France
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Poitiers , 86000, France
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Saint-Herblain Cédex , 44805, France
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Strasbourg Cedex , 67091, France
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Suresnes , 92150, France
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Toulouse , 31400, France
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Batumi , 6000, Georgia
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Tbilisi , 0144, Georgia
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Tbilisi , 0159, Georgia
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Tbilisi , 0160, Georgia
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Tbilisi , 112, Georgia
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Heidelberg Baden-Württemberg, 69126, Germany
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Gauting Bayern, 82131, Germany
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Bochum Nordrhein Westfalen, 44791, Germany
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Velbert North Rhine-Westphalia, 42551, Germany
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Aachen , 52074, Germany
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Berlin , 12351, Germany
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Berlin , 13125, Germany
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Berlin , 14165, Germany
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Chemnitz , 09113, Germany
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Dresden , 01307, Germany
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Erfurt , 99089, Germany
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Essen , 45147, Germany
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Georgsmarienhuette , 49124, Germany
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Gera , 07548, Germany
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Gerlingen , 70839, Germany
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Grosshansdorf , 22947, Germany
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Halle (Saale) , 06120, Germany
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Koeln , 51109, Germany
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Leipzig , D-043, Germany
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Minden , 32429, Germany
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Muenchen , 81377, Germany
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Nuernberg , 90419, Germany
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Solingen , 42699, Germany
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Ulm , 89081, Germany
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Wuerzburg , 97074, Germany
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Athens Attica, 15562, Greece
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Athens GR, 115 2, Greece
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Athens , 11526, Greece
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Athens , 18547, Greece
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Athens , GR145, Greece
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Thessaloniki , 57001, Greece
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Hong Kong , , Hong Kong
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Kowloon , , Hong Kong
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Tuen Mun , 99907, Hong Kong
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Torokbalint Pest, 2045, Hungary
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Veszprem , 8200, Hungary
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Reykjavik , IS-10, Iceland
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Mumbai Maharashtra, 40002, India
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Nashik Maharashtra, 422 0, India
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Kolkata West Bengal, 70016, India
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Delhi , 110 0, India
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Haifa , 31096, Israel
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Holon , 58100, Israel
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Ancona AN, 60126, Italy
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Bari BA, 70124, Italy
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Meldola FC, 47014, Italy
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Monza MB, 20900, Italy
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Milano MI, 20132, Italy
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Milano MI, 20133, Italy
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Padova PD, 35100, Italy
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Perugia PG, 06129, Italy
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Aviano PN, 33081, Italy
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Ravenna RA, 48100, Italy
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Roma RM, 00189, Italy
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Orbassano TO, 10043, Italy
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Nagoya Aichi, 464 8, Japan
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Nagoya Aichi, 466 8, Japan
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Hirosaki Aomori, 036 8, Japan
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Matsuyama Ehime, 791-0, Japan
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Iizuka-city Fukuoka, 820-8, Japan
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Asahikawa-city Hokkaido, 070-8, Japan
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Sapporo city Hokkaido, 060 8, Japan
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Himeji Hyogo, 670-8, Japan
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Kanazawa-city Ishikawa, 920-8, Japan
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Shiwa-gun Iwate, 028-3, Japan
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Yokohama-city Kanagawa, 236 0, Japan
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Yokohama-city Kanagawa, 241-8, Japan
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Natori Miyagi, 981-1, Japan
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Hirakata-city Osaka, 573-1, Japan
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Osaka-city Osaka, 541-8, Japan
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Sakai Osaka, 591-8, Japan
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Hidaka-city Saitama, 350-1, Japan
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Sunto Gun Shizuoka, 411 8, Japan
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Bunkyo ku Tokyo, 113-8, Japan
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Chuo ku Tokyo, 104 0, Japan
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Minato ku Tokyo, 105-8, Japan
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Ube-city Yamaguchi, 755-0, Japan
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Fukuoka , 810-8, Japan
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Osaka , 545-8, Japan
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Wakayama , 641-8, Japan
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Amman , 11941, Jordan
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Cheongju si Chungcheongbuk Do, 28644, Korea, Republic of
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Jeollanam-do Korea, 58128, Korea, Republic of
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Seoul Korea, 08308, Korea, Republic of
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Busan , 48108, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Ashrafieh , 16683, Lebanon
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Beirut , 10999, Lebanon
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Saida , 652, Lebanon
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Tripoli , 1434, Lebanon
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Kuching Sarawak, 93586, Malaysia
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Kuala Lumpur , 59100, Malaysia
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Pulau Pinang , 10990, Malaysia
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Bergen , 5021, Norway
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Drammen , 3004, Norway
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Oslo , 0424, Norway
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Tromso , 9019, Norway
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Panama City , 0801, Panama
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San Borja Lima, 41, Peru
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Surquillo Lima, 34, Peru
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Makati City , 1229, Philippines
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Krakow Ma3opolska, 31-82, Poland
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Konin , 62 50, Poland
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Olsztyn , 10-28, Poland
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Poznan , 60-69, Poland
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Rzeszow , 35-02, Poland
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Warszawa , 02 78, Poland
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Lisboa , 1769-, Portugal
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Matosinhos , 4454 , Portugal
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Porto , 4100-, Portugal
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Floresti Cluj, 40728, Romania
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Bucuresti , 01099, Romania
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Cluj-Napoca , 40012, Romania
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Iasi , 70048, Romania
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Arkhangelsk , 16304, Russian Federation
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Kaliningrad , 23600, Russian Federation
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Moscow Region Istra Village , 14342, Russian Federation
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Obninsk , 24903, Russian Federation
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Omsk , 64401, Russian Federation
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Pushkin Saint Petersburg , 19660, Russian Federation
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Ryazan , 39001, Russian Federation
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Saint Petersburg , 19702, Russian Federation
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St Petersburg , 19214, Russian Federation
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St Petersburg , 19775, Russian Federation
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Yaroslavl , 15005, Russian Federation
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Ljubljana , 1000, Slovenia
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Cordoba Andalucia, 14004, Spain
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Sevilla Andalucia, 41013, Spain
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Santander Cantabria, 39008, Spain
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Badalona Catalunya, 08916, Spain
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Barcelona Catalunya, 08036, Spain
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Hospitalet de LLobregat Catalunya, 08907, Spain
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Valencia Comunidad Valenciana, 46010, Spain
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Santiago De Compostela Galicia, 15706, Spain
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La Laguna Santa Cruz De Tenerife, 38320, Spain
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Madrid , 28006, Spain
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Madrid , 28009, Spain
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Madrid , 28041, Spain
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Bern , 3010, Switzerland
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Fribourg , 1708, Switzerland
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Geneve 14 , CH 12, Switzerland
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Taichung Taiwan ROC, 40201, Taiwan
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Changhua , 50006, Taiwan
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Hualien , 970, Taiwan
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Kaohsiung , 82445, Taiwan
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Kaohsiung , 83301, Taiwan
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Taichung , 40447, Taiwan
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Taichung , 40705, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 11217, Taiwan
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Taoyuan , 33305, Taiwan
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Songkhla Hat Yai, 90110, Thailand
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Khon Kaen THA, 40002, Thailand
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Bangkok , 10300, Thailand
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Bangkok , 10330, Thailand
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Bangkok , 10400, Thailand
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Bangkok , 10700, Thailand
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Chaingmai , 50200, Thailand
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Ankara Yenimahalle, 06200, Turkey
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Adana , 01250, Turkey
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Istanbul , 34303, Turkey
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Izmir , 35575, Turkey
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Pendik Istanbul , 34899, Turkey
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Cambridge Cambrigdeshire, CB2 0, United Kingdom
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Truro Cornwall, TR1 3, United Kingdom
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Cheltenham Gloucestershire, GL53 , United Kingdom
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Wirral Merseyside, CH63 , United Kingdom
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Ipswich Suffolk, IP4 5, United Kingdom
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Guildford Surrey, GU2 7, United Kingdom
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Birmingham , B9 5S, United Kingdom
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Bristol , BS2 8, United Kingdom
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Leicester , LE1 5, United Kingdom
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London , EC14 , United Kingdom
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London , NW3 2, United Kingdom
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Nottingham , NG5 1, United Kingdom
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Oxford , OX3 7, United Kingdom
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Preston , PR2 9, United Kingdom
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Stoke-on-Trent , ST4 6, United Kingdom
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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:

Terminated

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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