NCT03447769

Brief Summary

The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T\>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,382

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2018

Geographic Reach
41 countries

283 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

March 16, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

February 19, 2018

Results QC Date

December 27, 2023

Last Update Submit

October 7, 2024

Conditions

Keywords

Non-Small Cell Lung CancerNSCLCACZ885canakinumabadjuvantAJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Overall Survival (OS)

    Up to approximately 4.3 years

  • Overall Survival (OS) in PD-L1 Subgroups

    Up to approximately 4.3 years

  • Overall Survival (OS) in CD8 Subgroups

    up to approximately 4.3 years

  • Lung Cancer Specific Survival (LCSS)

    Up to approximately 4.3 years

  • Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups

    Up to approximately 4 years

  • +9 more secondary outcomes

Study Arms (2)

canakinumab

EXPERIMENTAL

Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)

Drug: Canakinumab

Placebo

PLACEBO COMPARATOR

Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)

Drug: Placebo

Interventions

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.

Also known as: ACZ885
canakinumab

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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (283)

Highlands Oncology Group .

Fayetteville, Arkansas, 72703, United States

Location

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

VA Palo Alto Health Care System CRLX030A2301

Palo Alto, California, 94304-1207, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)

Longmont, Colorado, 80501, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Advanced Medical Specialties Drug Ship - 2

Miami, Florida, 33176, United States

Location

Florida Cancer Affiliates of Ocala

Ocala, Florida, 34474, United States

Location

Florida Cancer Specialists North

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Rush University Medical Center Regulatory

Chicago, Illinois, 60612, United States

Location

Cancer Center of Kansas Dept.ofCancerCtr.ofKansas

Wichita, Kansas, 67214-3728, United States

Location

VA Nebraska-W IA Health Care System .

Omaha, Nebraska, 68105, United States

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Louis Stokes Cleveland Department of Veterans Affairs MC .

Cleveland, Ohio, 44106, United States

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Oncology Associates of Oregon, PC

Eugene, Oregon, 97401-8122, United States

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Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology

Chattanooga, Tennessee, 37404, United States

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Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

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Texas Oncology MamieMcFaddenWardCtr

Dallas, Texas, 75246, United States

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Virginia Cancer Specialists Fairfax Northern Virginia

Fairfax, Virginia, 22031, United States

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Oncology and Hematology Associates of Southwest Virginia Inc .

Salem, Virginia, 24153, United States

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Novartis Investigative Site

CABA, Buenos Aires, C1426ANZ, Argentina

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Mar del Plata, Buenos Aires, B7600FZN, Argentina

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Rosario, Santa Fe Province, S2000DSV, Argentina

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Rosario, Sante Fe, S200KZE, Argentina

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Córdoba, X5016KEH, Argentina

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Graz, 8036, Austria

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Klagenfurt, 9020, Austria

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Krems, A-3500, Austria

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Vienna, A 1090, Austria

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Londrina, Paraná, 86015-520, Brazil

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Teresina, Piauí, 64049-200, Brazil

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Barretos, São Paulo, 14784 400, Brazil

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São Paulo, São Paulo, 01246 000, Brazil

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São Paulo, São Paulo, 04014-002, 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 1Z2, Canada

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Moncton, New Brunswick, E1C 6Z8, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Québec, Quebec, GIV 4G5, Canada

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Santiago, 7500006, Chile

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Santiago, 7500921, Chile

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Hefei, Anhui, 230001, China

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Beijing, Beijing Municipality, 100039, China

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Chongqing, Chongqing Municipality, 400037, China

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Guangzhou, Guangdong, 510000, China

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Shenzhen, Guangdong, 518020, China

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Zhanjing, Guangong, 524000, China

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Zunyi, Guizhou, 563000, China

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Zhengzhou, Henan, 450008, China

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Nanjing, Jiangsu, 210008, China

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Suzhou, Jiangsu, 215004, China

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Changchun, Jilin, 130021, China

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Shenyang, Liaoning, 110011, China

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Jinan, Shandong, 250117, China

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Shanghai, Shanghai Municipality, 200032, China

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Shanghai, Shanghai Municipality, 200433, China

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Xi’an, Shanxi, 710061, China

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Shenyang, Shengyang, 110041, China

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Chengdu, Sichuan, 610041, China

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Hangzhou, Zhejiang, 310003, China

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Hangzhou, Zhejiang, 310022, China

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Beijing, 100036, China

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Changsha, 410013, China

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Chengdu, 610044, China

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Fujian, 350001, China

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Tianjin, 300000, China

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Tianjin, 300052, China

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Bogotá, 110221, Colombia

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Ostrava Vitkovice, 703 84, Czechia

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Prague, 128 21, Czechia

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Marseille, Bouches Du Rhone, 13915, France

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Le Mans, Cedex 09, 72037, France

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Montpellier, Herault, 34059, France

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Amiens, 80054, France

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Angers, 49933, France

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Avignon, 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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Créteil, 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, 33604, France

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Poitiers, 86000, France

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Saint-Herblain Cédex, 44805, France

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Strasbourg, 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-Wurttemberg, 69126, Germany

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Gauting, Bavaria, 82131, Germany

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Bochum, North Rhine-Westphalia, 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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Cologne, 51109, 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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Georgsmarienhütte, 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, 06120, Germany

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Leipzig, D-04347, Germany

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Minden, 32429, Germany

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München, 81377, Germany

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Nuremberg, 90419, Germany

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Solingen, 42699, Germany

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Ulm, 89081, Germany

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Würzburg, 97074, Germany

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Athens, Attica, 15562, Greece

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Athens, GR, 115 27, Greece

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Athens, 11526, Greece

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Athens, 18547, Greece

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Athens, GR14564, 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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Tuenmen, 999077, Hong Kong

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Törökbálint, Pest County, 2045, Hungary

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Veszprém, 8200, Hungary

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Reykjavik, IS-101, Iceland

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Mumbai, Maharashtra, 400022, India

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Nashik, Maharashtra, 422 004, India

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Kolkata, West Bengal, 700160, India

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Delhi, 110 085, India

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Haifa, 3109601, 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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Milan, MI, 20132, Italy

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Milan, MI, 20133, Italy

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Padua, 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-ken, 464 8681, Japan

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Nagoya, Aichi-ken, 466 8560, Japan

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Hirosaki, Aomori, 036 8563, Japan

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Matsuyama, Ehime, 791-0280, Japan

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Iizuka, Fukuoka, 820-8505, Japan

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Asahikawa, Hokkaido, 070-8644, Japan

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Sapporo, Hokkaido, 060 8648, Japan

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Himeji, Hyōgo, 670-8520, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Shiwa-gun, Iwate, 028-3695, Japan

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Yokohama, Kanagawa, 236 0051, Japan

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Yokohama, Kanagawa, 241-8515, Japan

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Natori-shi, Miyagi, 981-1293, Japan

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Hirakata, Osaka, 573-1191, Japan

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Osaka, Osaka, 541-8567, Japan

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Sakai, Osaka, 591-8555, Japan

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Hidaka, Saitama, 350-1298, Japan

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Sunto Gun, Shizuoka, 411 8777, Japan

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Bunkyo Ku, Tokyo, 113-8431, Japan

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Chuo Ku, Tokyo, 104 0045, Japan

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Minato Ku, Tokyo, 105-8470, Japan

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Ube, Yamaguchi, 755-0241, Japan

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Fukuoka, 810-8563, Japan

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Osaka, 545-8586, Japan

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Wakayama, 641-8510, Japan

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Amman, 11941, Jordan

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Beirut, 10999, Lebanon

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El Achrafiyé, 166830, 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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Tromsø, 9019, Norway

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Panama City, 0801, Panama

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San Borja, Lima region, 41, Peru

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Surquillo, Lima region, 34, Peru

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Makati City, 1229, Philippines

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Krakow, Ma3opolska, 31-826, Poland

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Konin, 62 500, Poland

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Olsztyn, 10-288, Poland

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Poznan, 60-693, Poland

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Rzeszów, 35-021, Poland

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Warsaw, 02 781, Poland

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Lisbon, 1769-001, Portugal

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Matosinhos Municipality, 4454 513, Portugal

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Porto, 4100-180, Portugal

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Floreşti, Cluj, 407280, Romania

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Bucharest, 010991, Romania

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Cluj-Napoca, 400124, Romania

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Iași, 700483, Romania

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Arkhangelsk, 163045, Russia

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Kaliningrad, 236006, Russia

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Moscow Region Istra Village, 143423, Russia

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Obninsk, 249036, Russia

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Omsk, 644013, Russia

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Pushkin Saint Petersburg, 196603, Russia

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Ryazan, 390011, Russia

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Saint Petersburg, 192148, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Yaroslavl, 150054, Russia

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Ljubljana, 1000, Slovenia

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Jeollanam-do, Korea, 58128, South Korea

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Seoul, Korea, 08308, South Korea

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Cheongju-si, North Chungcheong, 28644, South Korea

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Busan, 48108, South Korea

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Seoul, 03080, South Korea

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Seoul, 03722, South Korea

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Seoul, 05505, South Korea

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Córdoba, Andalusia, 14004, Spain

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Seville, Andalusia, 41013, Spain

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Santander, Cantabria, 39008, Spain

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Badalona, Catalonia, 08916, Spain

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Barcelona, Catalonia, 08036, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Santiago de Compostela, Galicia, 15706, Spain

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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

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Valencia, Valencia, 46010, 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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Geneva, CH 1211, Switzerland

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Taichung, Taiwan ROC, 40201, Taiwan

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Changhua, 50006, Taiwan

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Hualien City, 970, Taiwan

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Kaohsiung City, 82445, Taiwan

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Kaohsiung City, 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 District, 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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Pendik Istanbul, Turkey, 34899, Turkey (Türkiye)

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Ankara, Yenimahalle, 06200, Turkey (Türkiye)

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Adana, 01250, Turkey (Türkiye)

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Istanbul, 34303, Turkey (Türkiye)

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Izmir, 35575, Turkey (Türkiye)

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Cambridge, Cambrigdeshire, CB2 0QQ, United Kingdom

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

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Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

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Ipswich, Suffolk, IP4 5PD, United Kingdom

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Guildford, Surrey, GU2 7XX, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Bristol, BS2 8HN, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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London, EC14 7BE, United Kingdom

Location

Novartis Investigative Site

London, NW3 2QG, United Kingdom

Location

Novartis Investigative Site

Nottingham, NG5 1PB, United Kingdom

Location

Novartis Investigative Site

Oxford, OX3 7LJ, United Kingdom

Location

Novartis Investigative Site

Preston, PR2 9HT, United Kingdom

Location

Novartis Investigative Site

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Novartis Investigative Site

Hanoi, 100000, Vietnam

Location

Related Publications (1)

  • Garon EB, Lu S, Goto Y, De Marchi P, Paz-Ares L, Spigel DR, Thomas M, Yang JC, Ardizzoni A, Barlesi F, Orlov S, Yoshioka H, Mountzios G, Khanna S, Bossen C, Carbini M, Turri S, Myers A, Cho BC. Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial. J Clin Oncol. 2024 Jan 10;42(2):180-191. doi: 10.1200/JCO.23.00910. Epub 2023 Oct 3.

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Study director
Organization
Novartis Pharmaceuticals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 27, 2018

Study Start

March 16, 2018

Primary Completion

March 17, 2022

Study Completion

February 7, 2023

Last Updated

October 9, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Locations