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

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)

ClinicalTrials.gov Identifier: NCT03626545

Novartis Reference Number: CACZ885V2301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Non-Small-Cell Lung
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
245 participants
Start date 
Jan 23, 2019
Completion date 
Mar 30, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Canakinumab
Canakinumab, subcutaneous, administred at the recommended Phase III regimen (defined in the safety run-in part)
Drug
Docetaxel
Standard of care: docetaxel 75mg/m2, intravenous, every 3 weeks
Other
Placebo
Placebo, sub-cutaneous, administered at the recommended Phase III regimen (defined in the safety run-in part).

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 Locations

United States
Emory University School of Medicine/Winship Cancer Institute
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Atlanta, 30322
Georgia
United States
Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of Regulatory
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Kansas City, 64111
Missouri
United States
Montefiore Medical Center Albert Einstein College of Med
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Bronx, 10461
New York
United States
University of Cincinnati Cancer Institute
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Cincinnati, 45267
Ohio
United States
MD Anderson
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Houston, 77030
Texas
United States
Huntsman Cancer Institute Univ of Utah
-
Salt Lake City, 84112 0550
Utah
United States
Argentina
Novartis Investigative Site
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Berazategui, B1884BBF
Buenos Aires
Argentina
Novartis Investigative Site
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Caba, C1426ANZ
Buenos Aires
Argentina
Novartis Investigative Site
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Mar del Plata, B7600FZN
Buenos Aires
Argentina
Novartis Investigative Site
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La Rioja, 5300
-
Argentina
Novartis Investigative Site
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Santiago del Estero, 4200
-
Argentina
Australia
Novartis Investigative Site
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Greenslopes, 4120
Queensland
Australia
Novartis Investigative Site
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Shepparton, 3630
Victoria
Australia
Belgium
Novartis Investigative Site
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Sint Niklaas, 9100
Vlaams Brabant
Belgium
Novartis Investigative Site
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Bruxelles, 1200
-
Belgium
Novartis Investigative Site
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Charleroi, 6000
-
Belgium
Novartis Investigative Site
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Gent, 9000
-
Belgium
Novartis Investigative Site
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Roeselare, 8800
-
Belgium
Brazil
Novartis Investigative Site
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Salvador, 40170-110
BA
Brazil
Novartis Investigative Site
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Porto Alegre, 90880-480
RS
Brazil
Novartis Investigative Site
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Itajai, 88301-229
SC
Brazil
Canada
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Vancouver, V5Z 4E6
British Columbia
Canada
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Montreal, H4A 3J1
Quebec
Canada
Chile
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Santiago,
-
Chile
China
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Chengdu, 610041
Sichuan
China
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Shanghai, 200433
-
China
Czechia
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Brno - Bohunice, 639 01
-
Czechia
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Ostrava Vitkovice, 703 84
-
Czechia
Denmark
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Herlev, DK 2730
-
Denmark
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Odense C, DK 5000
-
Denmark
France
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Le Mans, 72037
Cedex 09
France
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Besancon Cedex, 25030
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France
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Bordeaux Cedex, 33000
-
France
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Bron, 69677
-
France
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Strasbourg Cedex, 67091
-
France
Germany
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Berlin, 13125
-
Germany
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Dresden, 01307
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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
Greece
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Heraklion Crete, 711 10
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Greece
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Thessaloniki, 57001
-
Greece
Hungary
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Torokbalint, 2045
Pest
Hungary
Israel
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Ramat Gan, 52621
-
Israel
Italy
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Lucca, 55100
LU
Italy
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Rozzano, 20089
MI
Italy
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Aviano, 33081
PN
Italy
Japan
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Nagoya, 464 8681
Aichi
Japan
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Himeji, 670-8520
Hyogo
Japan
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Yokohama-city, 241-8515
Kanagawa
Japan
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Chuo ku, 104 0045
Tokyo
Japan
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Osaka, 545-8586
-
Japan
Jordan
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Amman, 11941
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Jordan
Korea, Republic of
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Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
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Seoul, 03722
-
Korea, Republic of
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Seoul, 05505
-
Korea, Republic of
Lebanon
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Ashrafieh, 166830
-
Lebanon
Netherlands
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Amsterdam, 1081 HV
-
Netherlands
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Groningen, 9713 GZ
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Netherlands
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Maastricht, 6229 HX
-
Netherlands
Poland
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Gdansk, 80 952
-
Poland
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Rzeszow, 35-021
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Poland
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Warszawa, 02 781
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Poland
Russian Federation
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Pushkin Saint Petersburg, 196603
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Russian Federation
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St Petersburg, 197758
-
Russian Federation
Singapore
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Singapore, 169610
-
Singapore
Spain
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Malaga, 29010
Andalucia
Spain
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Badalona, 08916
Catalunya
Spain
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Valencia, 46014
Comunidad Valenciana
Spain
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La Coruna, 15006
Galicia
Spain
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Madrid, 28034
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Spain
Novartis Investigative Site
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Madrid, 28040
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Spain
Novartis Investigative Site
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Madrid, 28041
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Spain
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Madrid, 28222
-
Spain
Taiwan
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Tainan, 70403
-
Taiwan
Novartis Investigative Site
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Taipei,
-
Taiwan

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Call 1-999-669-6682 or email [email protected]