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 (ADAURA2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509943-28-00

Acronym

D516FC00001(ADAURA2)

Enrollment

Registered

2024-09-25

Start date

2022-05-18

Completion date

Unknown

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

following complete tumour resection., L858R), Stage IA2-IA3 non-small cell lung carcinoma, with EGFR mutation type (Ex19del

Brief summary

Disease free survival (DFS) in the high-risk stratum by investigators' assessment.

Detailed description

Disease free survival (DFS) in the overall population by investigator's assessment., Disease free survival (DFS) in both the high-risk stratum and overall population., Overall survival (OS) in participants in both the high-risk stratum and overall population., Impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and overall population., Effectiveness of osimertinib versus placebo by assessment of central nervous system disease free survival (DFS) in both the high-risk stratum and the overall population., Characterise the pharmacokinetics of osimertinib and its metabolites (AZ13575104 [AZ5104]) in the overall population., Safety and tolerability profile of osimertinib versus placebo in the overall population.

Interventions

DRUGTAGRISSO 80 mg film-coated tablets

DRUGTAGRISSO 40 mg film-coated tablets

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease free survival (DFS) in the high-risk stratum by investigators' assessment.	—

Secondary

Measure	Time frame
Disease free survival (DFS) in the overall population by investigator's assessment., Disease free survival (DFS) in both the high-risk stratum and overall population., Overall survival (OS) in participants in both the high-risk stratum and overall population., Impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and overall population., Effectiveness of osimertinib versus placebo by assessment of central nervous system disease free survival (DFS) in both the high-risk stratum and the overall population., Characterise the pharmacokinetics of osimertinib and its metabolites (AZ13575104 [AZ5104]) in the overall population., Safety and tolerability profile of osimertinib versus placebo in the overall population.	—

Measure

Time frame

—

Countries

Germany, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026