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A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
Sponsor: AstraZeneca
Summary
This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.
Official title: A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib Versus Placebo in Participants With EGFR Mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, Following Complete Tumour Resection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2022-02-21
Completion Date
2032-11-01
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Osimertinib
The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease recurrence, unacceptable toxicity or other discontinuation criteria are met.
Placebo
Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.
Locations (139)
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Anchorage, Alaska, United States
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Los Angeles, California, United States
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Orange, California, United States
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Grand Junction, Colorado, United States
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Newark, Delaware, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Frederick, Maryland, United States
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Morristown, New Jersey, United States
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Flushing, New York, United States
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New York, New York, United States
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New York, New York, United States
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White Plains, New York, United States
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Houston, Texas, United States
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Fort Belvoir, Virginia, United States
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Buenos Aires, Argentina
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CABA, Argentina
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Cipolletti, Argentina
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La Plata, Argentina
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Rosario, Argentina
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Rosario, Argentina
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S.C. de Bariloche, Argentina
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Barretos, Brazil
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Belo Horizonte, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Montreal, Quebec, Canada
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Toronto, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chengdu, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Harbin, China
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Jinan, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shenzhen, China
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Suzhou, China
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Taiyuan, China
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Xi'an, China
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Xintai, China
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Yangzhou, China
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Zhengzhou, China
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Berlin, Germany
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Esslingen am Neckar, Germany
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Georgsmarienhütte, Germany
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Lübeck, Germany
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München, Germany
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Würzburg, Germany
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Bari, Italy
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Catania, Italy
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Florence, Italy
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Genova, Italy
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Milan, Italy
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Naples, Italy
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Padova, Italy
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Parma, Italy
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Roma, Italy
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Chiba, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Kashiwa, Japan
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Kōtoku, Japan
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Kyoto, Japan
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Niigata, Japan
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Osaka, Japan
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Sakai, Japan
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Sendai, Japan
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Shinjuku-ku, Japan
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Sunto-gun, Japan
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Wakayama, Japan
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Kuala Lumpur, Malaysia
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Kuala Selangor, Malaysia
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Kuching, Malaysia
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Pulau Pinang, Malaysia
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Poznan, Poland
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Warsaw, Poland
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Bucharest, Romania
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Bucharest, Romania
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Perm, Russia
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Saint Petersburg, Russia
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Singapore, Singapore
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Singapore, Singapore
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Daegu, South Korea
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Jinju, 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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Suwon, South Korea
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Suwon, South Korea
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Barcelona, Spain
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Málaga, Spain
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Valencia, Spain
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Vigo, Spain
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Zaragoza, Spain
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Muang, Thailand
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kadıkoy/Istanbul, Turkey (Türkiye)
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Birmingham, United Kingdom
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Blackpool, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Wythenshawe, United Kingdom
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Hồ Chí Minh, Vietnam