A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection (ADAURA2)

July 2, 2026 updated by: AstraZeneca

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Research Site
      • CABA, Argentina, C1012AAR
        • Research Site
      • Cipolletti, Argentina, 8234
        • Research Site
      • La Plata, Argentina, 1900
        • Research Site
      • Rosario, Argentina, 2000
        • Research Site
      • Rosario, Argentina, S2000CVB
        • Research Site
      • S.C. de Bariloche, Argentina, 8400
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Belo Horizonte, Brazil, 30380-090
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Recife, Brazil, 52010-075
        • Research Site
      • Rio de Janeiro, Brazil, 22271-110
        • Research Site
      • São Paulo, Brazil, 04501-000
        • Research Site
      • São Paulo, Brazil, 01327-001
        • Research Site
  • Canada
      • Toronto, Canada, M5G 2M9
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
  • China
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, 100730
        • Research Site
      • Beijing, China, 100029
        • Research Site
      • Beijing, China, 100210
        • Research Site
      • Beijing, China, 102218
        • Research Site
      • Beijing, China, 100005
        • Research Site
      • Changchun, China, 130012
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Changsha, China, 430033
        • Research Site
      • Chengdu, China, 610000
        • Research Site
      • Fuzhou, China, 350014
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Guangzhou, China, 510100
        • Research Site
      • Hangzhou, China, 310022
        • Research Site
      • Harbin, China, 150049
        • Research Site
      • Jinan, China, 250117
        • Research Site
      • Nanjing, China, 210029
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200030
        • Research Site
      • Shenzhen, China, 518116
        • Research Site
      • Suzhou, China, 215006
        • Research Site
      • Taiyuan, China, 030000
        • Research Site
      • Xi'an, China, 710061
        • Research Site
      • Xintai, China, 54031
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
  • Germany
      • Berlin, Germany, 13125
        • Research Site
      • Esslingen am Neckar, Germany, 73730
        • Research Site
      • Georgsmarienhütte, Germany, 49124
        • Research Site
      • Lübeck, Germany, 23538
        • Research Site
      • München, Germany, 81377
        • Research Site
      • Würzburg, Germany, 97067
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Catania, Italy, 95100
        • Research Site
      • Florence, Italy, 50134
        • Research Site
      • Genova, Italy, 16132
        • Research Site
      • Milan, Italy, 20141
        • Research Site
      • Naples, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Parma, Italy, 43100
        • Research Site
      • Roma, Italy, 00144
        • Research Site
  • Japan
      • Chiba, Japan, 260-0877
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Hiroshima, Japan, 734-8551
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Research Site
      • Kyoto, Japan, 606-8507
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Niigata, Japan, 951-8566
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Sakai, Japan, 590-0197
        • Research Site
      • Sendai, Japan, 981-0914
        • Research Site
      • Shinjuku-ku, Japan, 160-0023
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Wakayama, Japan, 641-8510
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Kuala Selangor, Malaysia, 46050
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
      • Pulau Pinang, Malaysia, 10450
        • Research Site
  • Poland
      • Poznan, Poland, 60-569
        • Research Site
      • Warsaw, Poland, 01-138
        • Research Site
  • Romania
      • Bucharest, Romania, 050098
        • Research Site
      • Bucharest, Romania, 022328
        • Research Site
  • Russia
      • Perm, Russia, 614990
        • Research Site
      • Saint Petersburg, Russia, 191036
        • Research Site
  • Singapore
      • Singapore, Singapore, 169610
        • Research Site
      • Singapore, Singapore, 308433
        • Research Site
  • South Korea
      • Daegu, South Korea, 42415
        • Research Site
      • Jinju, South Korea, 52727
        • Research Site
      • Seoul, South Korea, 05505
        • Research Site
      • Seoul, South Korea, 03082
        • Research Site
      • Seoul, South Korea, 07061
        • Research Site
      • Suwon, South Korea, 16499
        • Research Site
      • Suwon, South Korea, 16247
        • Research Site
  • Spain
      • Barcelona, Spain, 08041
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
      • Vigo, Spain, 36312
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40201
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan, 235
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taipei, Taiwan, 114
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10300
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Research Site
      • Bursa, Turkey (Türkiye), 16059
        • Research Site
      • Istanbul, Turkey (Türkiye)
        • Research Site
      • Izmir, Turkey (Türkiye), 35040
        • Research Site
      • Kadıkoy/Istanbul, Turkey (Türkiye), 34722
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Research Site
      • Blackpool, United Kingdom, FY3 8NR
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • London, United Kingdom, SW3 6NP
        • Research Site
      • London, United Kingdom, SW10 9NH
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Wythenshawe, United Kingdom, M23 9LT
        • Research Site
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Research Site
    • California
      • Los Angeles, California, United States, 90024
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Research Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Research Site
    • New York
      • Flushing, New York, United States, 11355
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
      • New York, New York, United States, 10065
        • Research Site
      • White Plains, New York, United States, 10601
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Hồ Chí Minh, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Male or female, at least ≥ 18 years.
  2. NSCLC, of non-squamous histology.
  3. Stage IA2 or IA3 disease, based on TNM8 classification.
  4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
  5. Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
  6. World Health Organization performance status of 0 or 1.
  7. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
  8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.
  9. Minimum life expectancy of > 6 months.
  10. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.

Exclusion Criteria

  1. Mixed small cell and non-small cell cancer history.
  2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.
  3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection.
  4. History of another primary malignancy, including any known or suspected synchronous primary lung cancer except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.

  5. Any of the following cardiac criteria:

    • Mean resting QTcF interval > 470 ms, obtained from triplicate ECGs performed at screening.
    • Any abnormalities in rhythm, conduction, or morphology of resting ECG,
    • Any factors that increase the risk of QTcF prolongation or risk of arrhythmic events.
  6. History of interstitial lung disease.
  7. Inadequate bone marrow reserve or organ function.
  8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
  9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
  10. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
  11. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) in high-risk stratum
Time Frame: From date of randomisation up to approximately 10 years

DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.

Stratification to the high risk stratum will be based on pathologic features assessed by central pathology review during screening.
From date of randomisation up to approximately 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) in overall population
Time Frame: From date of randomisation up to approximately 10 years
DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.
From date of randomisation up to approximately 10 years
Overall Survival (OS) in high-risk stratum and the overall population
Time Frame: From date of randomization up to approximately 10 years
OS is defined as the time from the date of randomisation until death due to any cause.
From date of randomization up to approximately 10 years
PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population
Time Frame: From date of randomisation up to approximately 10 years
Ratio of metabolite-to-osimertinib to be calculated at predose, and at 0.5-2 hours postdose.
From date of randomisation up to approximately 10 years
Impact of osimertinib versus placebo on physical functioning
Time Frame: From date of randomisation up to approximately 10 years
Assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and the overall population as measured by SF-36 V2 health survey
From date of randomisation up to approximately 10 years
Central Nervous System (CNS) Disease-Free Survival (DFS) in both the high-risk stratum and the overall population
Time Frame: From date of randomisation up to approximately 10 years
CNS DFS is defined as the time from randomisation to the time of a CNS lesion (as assessed by investigator) or death due to any cause, regardless of whether the participant withdraws from study intervention or receives other anti-cancer therapy.
From date of randomisation up to approximately 10 years
Safety and tolerability in overall population
Time Frame: From date of randomisation up to approximately 10 years
AEs graded by CTCAE version 5.0
From date of randomisation up to approximately 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yasuhiro Tsutani, MD, PhD, Kindai University Facility of Medicine
  • Principal Investigator: Jie He, MD, PhD, The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)
  • Principal Investigator: Jonathan Goldman, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D516FC00001
  • 2021-004135-89 (EudraCT Number)
  • 2023-509943-28 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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