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TERMINATED
NCT03631199
PHASE3

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This was 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 participants.

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)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

673

Start Date

2018-12-21

Completion Date

2026-01-26

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DRUG

canakinumab

canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)

DRUG

canakinumab-matching placebo

canakinumab placebo every 3 weeks (squamous and non-squamous)

DRUG

pembrolizumab

200 mg every 3 weeks (squamous and non-squamous)

DRUG

carboplatin

Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)

DRUG

cisplatin

75 mg/m\^2 every 3 weeks (non-squamous)

DRUG

paclitaxel

200 mg/m\^2 every 3 weeks (squamous)

DRUG

nab-paclitaxel

100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)

DRUG

pemetrexed

500 mg/m\^2 every 3 weeks (non-squamous)

Locations (152)

Pacific Shores Medical Group

Long Beach, California, United States

USC Kenneth Norris Comprehensive Cancer Center

Los Angeles, California, United States

AdventHealth

Orlando, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Caba, 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, Upper Austria, Austria

Novartis Investigative Site

Salzburg, Austria

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Brampton, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Temuco, Araucania, Chile

Novartis Investigative Site

Santiago, Chile

Novartis Investigative Site

Harbin, Heilongjiang, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Changsha, Hunan, China

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Changchun, Jilin, China

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Xi’an, Shanxi, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

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Beijing, China

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Valledupar, Cesar Department, Colombia

Novartis Investigative Site

Ostrava, Vitkovice, Czechia

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Brno, Czechia

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Brno, Czechia

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Prague, Czechia

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Herning, Denmark

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Oulu, Finland

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Marseille, Bouches Du Rhone, France

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Lyon, France

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Montpellier, France

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Nantes, France

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Paris, France

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Munich, Bavaria, Germany

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Göttingen, Lower Saxony, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Berlin, Germany

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Essen, Germany

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Georgsmarienhütte, Germany

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Gerlingen, Germany

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Heidelberg, Germany

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Athens, GR, Greece

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Athens, Greece

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Kowloon, Hong Kong

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Veszprém, Hungary

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Reykjavik, Iceland

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Hyderabad, Andhra Pradesh, India

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Gurgaon, Haryana, India

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Pune, Maharashtra, India

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Jaipur, Rajasthan, India

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Hyderabad, Telangana, India

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Kolkata, West Bengal, India

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Avellino, AV, Italy

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Genova, GE, Italy

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Milan, MI, Italy

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Perugia, PG, Italy

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Parma, PR, Italy

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Orbassano, TO, Italy

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Milan, Italy

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Nagoya, Aichi-ken, Japan

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Sapporo, Hokkaido, Japan

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Himeji, Hyōgo, Japan

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Yokohama, Kanagawa, Japan

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Sakai, Osaka, Japan

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Sunto Gun, Shizuoka, Japan

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Chuo Ku, Tokyo, Japan

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Ube, Yamaguchi, Japan

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Osaka, Japan

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Beirut, Lebanon

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Saida, Lebanon

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Kuala Lumpur, Kuala Lumpur, Malaysia

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Kuantan, Pahang, Malaysia

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Kuching, Sarawak, Malaysia

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Kuala Lumpur, Malaysia

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Groningen, Netherlands

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Groningen, Netherlands

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Drammen, Norway

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City of Taguig, National Capital Region, Philippines

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Makati City, Philippines

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Quezon, Philippines

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San Juan City, Philippines

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Gliwice, Poland

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Poznan, Poland

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Tomaszw Mazowiecki, Poland

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Lisbon, Portugal

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Porto, Portugal

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Cluj-Napoca, Cluj, Romania

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Craiova, Dolj, Romania

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Arkhangelsk, Russia

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Omsk, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Singapore, Singapore

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Singapore, Singapore

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Singapore, Singapore

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Bratislava, Slovakia

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Kosice-Saca, Slovakia

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Gyeonggi-do, Korea, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Granada, Andalusia, Spain

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Badalona, Barcelona, Spain

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Donostia / San Sebastian, Gipuzkoa, Spain

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Las Palmas de Gran C, Las Palmas, Spain

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Valencia, Spain

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Zaragoza, Spain

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Stockholm, Sweden

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Basel, Switzerland

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Songkhla, Hat Yai, Thailand

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Khon Kaen, THA, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Istanbul, Bagcilar, Turkey (Türkiye)

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Ankara, Bilkent Cankaya, Turkey (Türkiye)

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Edirne, Merkez, Turkey (Türkiye)

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Ankara, Sihhiye-Altindag, Turkey (Türkiye)

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High Heaton, Newcastle Upon Tyne, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Plymouth, United Kingdom

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Hanoi, Vietnam