Spots Global Cancer Trial Database for A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
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Trial Identification
Brief Title: A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC 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
Study ID: NCT05120349
Conditions
Study Description
Brief 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.
Detailed Description: This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour resection. All participants must have had a tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R). Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms: osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria is met.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Anchorage, Alaska, United States
Research Site, Los Angeles, California, United States
Research Site, Orange, California, United States
Research Site, San Francisco, California, United States
Research Site, Grand Junction, Colorado, United States
Research Site, Newark, Delaware, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Lexington, Kentucky, United States
Research Site, Louisville, Kentucky, United States
Research Site, Frederick, Maryland, United States
Research Site, Morristown, New Jersey, United States
Research Site, Brooklyn, New York, United States
Research Site, Flushing, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Syracuse, New York, United States
Research Site, White Plains, New York, United States
Research Site, Greensboro, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Houston, Texas, United States
Research Site, Fort Belvoir, Virginia, United States
Research Site, Seattle, Washington, United States
Research Site, Buenos Aires, , Argentina
Research Site, Caba, , Argentina
Research Site, Caba, , Argentina
Research Site, Cipolletti, , Argentina
Research Site, La Plata, , Argentina
Research Site, Rosario, , Argentina
Research Site, Rosario, , Argentina
Research Site, S.C. De Bariloche, , Argentina
Research Site, Barretos, , Brazil
Research Site, Belo Horizonte, , Brazil
Research Site, Blumenau, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Recife, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Vancouver, British Columbia, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Toronto, , Canada
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changchun, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Guiyang, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Harbin, , China
Research Site, Jinan, , China
Research Site, Luoyang, , China
Research Site, Nanjing, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shenyang, , China
Research Site, Shenyang, , China
Research Site, Shenzhen, , China
Research Site, Suzhou, , China
Research Site, Taiyuan, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Xintai, , China
Research Site, Yangzhou, , China
Research Site, Zhengzhou, , China
Research Site, Berlin, , Germany
Research Site, Esslingen, , Germany
Research Site, Georgsmarienhuette, , Germany
Research Site, Hannover, , Germany
Research Site, Homburg, , Germany
Research Site, Lübeck, , Germany
Research Site, München, , Germany
Research Site, Oldenburg, , Germany
Research Site, Würzburg, , Germany
Research Site, Bari, , Italy
Research Site, Catania, , Italy
Research Site, Firenze, , Italy
Research Site, Genova, , Italy
Research Site, Milan, , Italy
Research Site, Napoli, , Italy
Research Site, Padova, , Italy
Research Site, Parma, , Italy
Research Site, Roma, , Italy
Research Site, Torino, , Italy
Research Site, Chiba-shi, , Japan
Research Site, Fukuoka-shi, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Koto-ku, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Wakayama-shi, , Japan
Research Site, Busan, , Korea, Republic of
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Jinju-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Kuala Lumpur, , Malaysia
Research Site, Kuching, , Malaysia
Research Site, Pulau Pinang, , Malaysia
Research Site, Selangor, , Malaysia
Research Site, Bystra, , Poland
Research Site, Kraków, , Poland
Research Site, Lublin, , Poland
Research Site, Olsztyn, , Poland
Research Site, Poznań, , Poland
Research Site, Szczecin, , Poland
Research Site, Warszawa, , Poland
Research Site, Bucharest, , Romania
Research Site, Bucuresti, , Romania
Research Site, Craiova, , Romania
Research Site, Floresti, , Romania
Research Site, Galati, , Romania
Research Site, Ovidiu, , Romania
Research Site, Kazan, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Nizhny Novgorod, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Perm, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Barcelona, , Spain
Research Site, Málaga, , Spain
Research Site, Valencia, , Spain
Research Site, Vigo, , Spain
Research Site, Zaragoza, , Spain
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Hat Yai, , Thailand
Research Site, Khon Kaen, , Thailand
Research Site, Muang, , Thailand
Research Site, Ankara, , Turkey
Research Site, Bursa, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Kadıkoy/Istanbul, , Turkey
Research Site, Birmingham, , United Kingdom
Research Site, Blackpool, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Nottingham, , United Kingdom
Research Site, Wythenshawe, , United Kingdom
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Jonathan Goldman, MD
Affiliation: UCLA Department of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Yasuhiro Tsutani, MD, PhD
Affiliation: Kindai University Facility of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Jie He, MD, PhD
Affiliation: The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)
Role: PRINCIPAL_INVESTIGATOR
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