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Spots Global Cancer Trial Database for Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

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Trial Identification

Brief Title: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

Official Title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

Study ID: NCT03631199

Conditions

Non-small Cell Lung Cancer

Interventions

canakinumab

canakinumab matching placebo

Study Description

Brief Summary: This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Pacific Shores Medical Group ., Long Beach, California, United States

USC Kenneth Norris Comprehensive Cancer Center ., Los Angeles, California, United States

Advent Health Cancer Institute, Orlando, Florida, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Novartis Investigative Site, Buenos Aires, , Argentina

Novartis Investigative Site, Westmead, New South Wales, Australia

Novartis Investigative Site, Wooloongabba, Queensland, Australia

Novartis Investigative Site, Melbourne, Victoria, Australia

Novartis Investigative Site, Murdoch, Western Australia, Australia

Novartis Investigative Site, Linz, Oberoesterreich, Austria

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Barretos, SP, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Edmonton, Alberta, Canada

Novartis Investigative Site, Brampton, Ontario, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Temuco, Region De La Araucania, Chile

Novartis Investigative Site, Santiago, , Chile

Novartis Investigative Site, Harbin, Heilongjiang, China

Novartis Investigative Site, Wuhan, Hubei, China

Novartis Investigative Site, Changsha, Hunan, China

Novartis Investigative Site, Changchun, Jilin, China

Novartis Investigative Site, XI An, Shanxi, China

Novartis Investigative Site, Hangzhou, Zhejiang, China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Valledupar, Cesar, Colombia

Novartis Investigative Site, Brno, Czech Republic, Czechia

Novartis Investigative Site, Prague 2, Czech Republic, Czechia

Novartis Investigative Site, Brno - Bohunice, , Czechia

Novartis Investigative Site, Ostrava Vitkovice, , Czechia

Novartis Investigative Site, Herning, , Denmark

Novartis Investigative Site, Oulu, , Finland

Novartis Investigative Site, Marseille cedex 20, Bouches Du Rhone, France

Novartis Investigative Site, Lyon, , France

Novartis Investigative Site, Montpellier, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Saint Herblain, , France

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Dresden, , Germany

Novartis Investigative Site, Essen, , Germany

Novartis Investigative Site, Georgsmarienhuette, , Germany

Novartis Investigative Site, Gerlingen, , Germany

Novartis Investigative Site, Gottingen, , Germany

Novartis Investigative Site, Halle (Saale), , Germany

Novartis Investigative Site, Heidelberg, , Germany

Novartis Investigative Site, Koeln, , Germany

Novartis Investigative Site, Leipzig, , Germany

Novartis Investigative Site, Muenchen, , Germany

Novartis Investigative Site, Athens, GR, Greece

Novartis Investigative Site, Athens, , Greece

Novartis Investigative Site, Kowloon, , Hong Kong

Novartis Investigative Site, Veszprem, , Hungary

Novartis Investigative Site, Reykjavik, , Iceland

Novartis Investigative Site, Hyderabad, Andhra Pradesh, India

Novartis Investigative Site, Gurgaon, Haryana, India

Novartis Investigative Site, Pune, Maharashtra, India

Novartis Investigative Site, Jaipur, Rajasthan, India

Novartis Investigative Site, Hyderabad, Telangana, India

Novartis Investigative Site, Kolkata, West Bengal, India

Novartis Investigative Site, Avellino, AV, Italy

Novartis Investigative Site, Genova, GE, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Rozzano, MI, Italy

Novartis Investigative Site, Modena, MO, Italy

Novartis Investigative Site, Padova, PD, Italy

Novartis Investigative Site, Perugia, PG, Italy

Novartis Investigative Site, Parma, PR, Italy

Novartis Investigative Site, Orbassano, TO, Italy

Novartis Investigative Site, Nagoya, Aichi, Japan

Novartis Investigative Site, Sapporo city, Hokkaido, Japan

Novartis Investigative Site, Himeji, Hyogo, Japan

Novartis Investigative Site, Yokohama-city, Kanagawa, Japan

Novartis Investigative Site, Sakai, Osaka, Japan

Novartis Investigative Site, Sunto Gun, Shizuoka, Japan

Novartis Investigative Site, Chuo ku, Tokyo, Japan

Novartis Investigative Site, Ube-city, Yamaguchi, Japan

Novartis Investigative Site, Osaka, , Japan

Novartis Investigative Site, Gyeonggi do, Korea, Korea, Republic of

Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Ashrafieh, , Lebanon

Novartis Investigative Site, Saida, , Lebanon

Novartis Investigative Site, Kuantan, Pahang, Malaysia

Novartis Investigative Site, Kuching, Sarawak, Malaysia

Novartis Investigative Site, Kuala Lumpur, Wilayah Persekutuan, Malaysia

Novartis Investigative Site, Kuala Lumpur, , Malaysia

Novartis Investigative Site, Groningen, , Netherlands

Novartis Investigative Site, Drammen, , Norway

Novartis Investigative Site, Taguig City, Metro Manila, Philippines

Novartis Investigative Site, Makati City, , Philippines

Novartis Investigative Site, Quezon, , Philippines

Novartis Investigative Site, San Juan City, , Philippines

Novartis Investigative Site, Gliwice, , Poland

Novartis Investigative Site, Poznan, , Poland

Novartis Investigative Site, Tomaszw Mazowiecki, , Poland

Novartis Investigative Site, Lisboa, , Portugal

Novartis Investigative Site, Porto, , Portugal

Novartis Investigative Site, Craiova, Dolj, Romania

Novartis Investigative Site, Cluj-Napoca, , Romania

Novartis Investigative Site, Arkhangelsk, , Russian Federation

Novartis Investigative Site, Omsk, , Russian Federation

Novartis Investigative Site, Pushkin Saint Petersburg, , Russian Federation

Novartis Investigative Site, Saint Petersburg, , Russian Federation

Novartis Investigative Site, St Petersburg, , Russian Federation

Novartis Investigative Site, Singapore, , Singapore

Novartis Investigative Site, Bratislava, , Slovakia

Novartis Investigative Site, Partizanske, , Slovakia

Novartis Investigative Site, Granada, Andalucia, Spain

Novartis Investigative Site, Malaga, Andalucia, Spain

Novartis Investigative Site, Badalona, Catalunya, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, San Sebastian, Pais Vasco, Spain

Novartis Investigative Site, Las Palmas De Gran Canarias, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Zaragoza, , Spain

Novartis Investigative Site, Stockholm, , Sweden

Novartis Investigative Site, Basel, , Switzerland

Novartis Investigative Site, Kaohsiung, , Taiwan

Novartis Investigative Site, Tainan, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Taoyuan, , Taiwan

Novartis Investigative Site, Songkhla, Hat Yai, Thailand

Novartis Investigative Site, Khon Kaen, THA, Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Edirne, , Turkey

Novartis Investigative Site, Istanbul, , Turkey

Novartis Investigative Site, High Heaton, Newcastle Upon Tyne, United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Manchester, , United Kingdom

Novartis Investigative Site, Plymouth, , United Kingdom

Novartis Investigative Site, Hanoi, , Vietnam

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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