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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 76 Locations for this study
Atlanta Georgia, 30322, United States
Kansas City Missouri, 64111, United States
Bronx New York, 10461, United States
Cincinnati Ohio, 45267, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Berazategui Buenos Aires, B1884, Argentina
Caba Buenos Aires, C1426, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
La Rioja , 5300, Argentina
Santiago del Estero , 4200, Argentina
Greenslopes Queensland, 4120, Australia
Shepparton Victoria, 3630, Australia
Sint Niklaas Vlaams Brabant, 9100, Belgium
Bruxelles , 1200, Belgium
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Roeselare , 8800, Belgium
Salvador BA, 40170, Brazil
Porto Alegre RS, 90880, Brazil
Itajai SC, 88301, Brazil
Vancouver British Columbia, V5Z 4, Canada
Montreal Quebec, H4A 3, Canada
Santiago , , Chile
Chengdu Sichuan, 61004, China
Shanghai , 20043, China
Brno - Bohunice , 639 0, Czechia
Ostrava Vitkovice , 703 8, Czechia
Herlev , DK 27, Denmark
Odense C , DK 50, Denmark
Le Mans Cedex 09, 72037, France
Besancon Cedex , 25030, France
Bordeaux Cedex , 33000, France
Bron , 69677, France
Strasbourg Cedex , 67091, France
Berlin , 13125, Germany
Dresden , 01307, Germany
Frankfurt , 60488, Germany
Gerlingen , 70839, Germany
Grosshansdorf , 22947, Germany
Koeln , 51109, Germany
Ulm , 89081, Germany
Heraklion Crete , 711 1, Greece
Thessaloniki , 57001, Greece
Torokbalint Pest, 2045, Hungary
Ramat Gan , 52621, Israel
Lucca LU, 55100, Italy
Rozzano MI, 20089, Italy
Aviano PN, 33081, Italy
Nagoya Aichi, 464 8, Japan
Himeji Hyogo, 670-8, Japan
Yokohama-city Kanagawa, 241-8, Japan
Chuo ku Tokyo, 104 0, Japan
Osaka , 545-8, Japan
Amman , 11941, Jordan
Seoul Seocho Gu, 06591, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Ashrafieh , 16683, Lebanon
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Maastricht , 6229 , Netherlands
Gdansk , 80 95, Poland
Rzeszow , 35-02, Poland
Warszawa , 02 78, Poland
Pushkin Saint Petersburg , 19660, Russian Federation
St Petersburg , 19775, Russian Federation
Singapore , 16961, Singapore
Malaga Andalucia, 29010, Spain
Badalona Catalunya, 08916, Spain
Valencia Comunidad Valenciana, 46014, Spain
La Coruna Galicia, 15006, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28222, Spain
Tainan , 70403, Taiwan
Taipei , , Taiwan
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.