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
18 Years - n/a
Endpoint Classification: -
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Verified 01 Jan 2024 by AstraZeneca
No locations available
Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)
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
Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.