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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Anchorage, Alaska, United States
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Research Site, Buenos Aires, , Argentina
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Research Site, Cipolletti, , Argentina
Research Site, La Plata, , Argentina
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Research Site, S.C. De Bariloche, , Argentina
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Research Site, Busan, , Korea, Republic of
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Research Site, Jinju-si, , Korea, Republic of
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Research Site, Moscow, , Russian Federation
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Research Site, Nizhny Novgorod, , Russian Federation
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Research Site, Bursa, , Turkey
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Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
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