Lung Cancer Clinical Trial

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

Summary

This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
Subject with ECOG performance status (PS) of 0 or 1.
Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria.

Key Exclusion Criteria:

Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
Subject with EGFRor ALK positive tumor.
History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.

Other protocol-defined inclusion/exclusion may apply.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

245

Study ID:

NCT03626545

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 76 Locations for this study

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Emory University School of Medicine/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of Regulatory
Kansas City Missouri, 64111, United States
Montefiore Medical Center Albert Einstein College of Med
Bronx New York, 10461, United States
University of Cincinnati Cancer Institute
Cincinnati Ohio, 45267, United States
MD Anderson
Houston Texas, 77030, United States
Huntsman Cancer Institute Univ of Utah
Salt Lake City Utah, 84112, United States
Novartis Investigative Site
Berazategui Buenos Aires, B1884, Argentina
Novartis Investigative Site
Caba Buenos Aires, C1426, Argentina
Novartis Investigative Site
Mar del Plata Buenos Aires, B7600, Argentina
Novartis Investigative Site
La Rioja , 5300, Argentina
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Santiago del Estero , 4200, Argentina
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Greenslopes Queensland, 4120, Australia
Novartis Investigative Site
Shepparton Victoria, 3630, Australia
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Sint Niklaas Vlaams Brabant, 9100, Belgium
Novartis Investigative Site
Bruxelles , 1200, Belgium
Novartis Investigative Site
Charleroi , 6000, Belgium
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Gent , 9000, Belgium
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Roeselare , 8800, Belgium
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Salvador BA, 40170, Brazil
Novartis Investigative Site
Porto Alegre RS, 90880, Brazil
Novartis Investigative Site
Itajai SC, 88301, Brazil
Novartis Investigative Site
Vancouver British Columbia, V5Z 4, Canada
Novartis Investigative Site
Montreal Quebec, H4A 3, Canada
Novartis Investigative Site
Santiago , , Chile
Novartis Investigative Site
Chengdu Sichuan, 61004, China
Novartis Investigative Site
Shanghai , 20043, China
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Brno - Bohunice , 639 0, Czechia
Novartis Investigative Site
Ostrava Vitkovice , 703 8, Czechia
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Herlev , DK 27, Denmark
Novartis Investigative Site
Odense C , DK 50, Denmark
Novartis Investigative Site
Le Mans Cedex 09, 72037, France
Novartis Investigative Site
Besancon Cedex , 25030, France
Novartis Investigative Site
Bordeaux Cedex , 33000, France
Novartis Investigative Site
Bron , 69677, France
Novartis Investigative Site
Strasbourg Cedex , 67091, France
Novartis Investigative Site
Berlin , 13125, Germany
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Dresden , 01307, Germany
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Frankfurt , 60488, Germany
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Gerlingen , 70839, Germany
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Grosshansdorf , 22947, Germany
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Koeln , 51109, Germany
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Ulm , 89081, Germany
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Heraklion Crete , 711 1, Greece
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Thessaloniki , 57001, Greece
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Torokbalint Pest, 2045, Hungary
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Ramat Gan , 52621, Israel
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Lucca LU, 55100, Italy
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Rozzano MI, 20089, Italy
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Aviano PN, 33081, Italy
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Nagoya Aichi, 464 8, Japan
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Himeji Hyogo, 670-8, Japan
Novartis Investigative Site
Yokohama-city Kanagawa, 241-8, Japan
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Chuo ku Tokyo, 104 0, Japan
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Osaka , 545-8, Japan
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Amman , 11941, Jordan
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Seoul Seocho Gu, 06591, 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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Amsterdam , 1081 , Netherlands
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Groningen , 9713 , Netherlands
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Maastricht , 6229 , Netherlands
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Gdansk , 80 95, Poland
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Rzeszow , 35-02, Poland
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Warszawa , 02 78, Poland
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Pushkin Saint Petersburg , 19660, Russian Federation
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St Petersburg , 19775, Russian Federation
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Singapore , 16961, Singapore
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Badalona Catalunya, 08916, Spain
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Valencia Comunidad Valenciana, 46014, Spain
Novartis Investigative Site
La Coruna Galicia, 15006, Spain
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Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28040, Spain
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Madrid , 28041, Spain
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Madrid , 28222, Spain
Novartis Investigative Site
Tainan , 70403, Taiwan
Novartis Investigative Site
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

245

Study ID:

NCT03626545

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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