Study identifier:D516FC00001
ClinicalTrials.gov identifier:NCT05120349
EudraCT identifier:2021-004135-89
CTIS identifier:2023-509943-28-00
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
Non-small Cell Lung Cancer
Phase 3
No
Osimertinib, Placebo
All
390
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Location
Beijing, China, 100210
Location
Kuching, Malaysia, 93586
Location
Kuala Lumpur, Malaysia, 59100
Location
Selangor, Malaysia, 46050
Location
Pulau Pinang, Malaysia, 10450
Location
Singapore, Singapore, 308433
Location
Seoul, Republic of Korea, 03082
Location
Kadıkoy/Istanbul, Turkey, 34722
Arms | Assigned Interventions |
---|---|
Experimental: Osimertinib Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator) | Drug: 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. Other Name: AZD9291; TAGRISSO |
Placebo Comparator: Placebo Matching placebo for osimertinib, orally, once daily | Drug: Placebo Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily. |
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