Non-Small Cell Lung CancerPhase 3ADAURA2NCT05120349
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
A Phase 3 study testing Osimertinib in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 139 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 139 sitesin 20 countries
- Study dates
- 21 Feb 2022to 1 Nov 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least ≥ 18 years.
- NSCLC, of non-squamous histology.
- Stage IA2 or IA3 disease, based on TNM8 classification.
- Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
- 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.
- World Health Organization performance status of 0 or 1.
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- Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
- A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.
- Minimum life expectancy of > 6 months.
- 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.
Who cannot join
- Mixed small cell and non-small cell cancer history.
- Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.
- 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.
- 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.
- Any of the following cardiac criteria:
- Mean resting QTcF interval > 470 ms, obtained from triplicate ECGs performed at screening.
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- Any abnormalities in rhythm, conduction, or morphology of resting ECG,
- Any factors that increase the risk of QTcF prolongation or risk of arrhythmic events.
- History of interstitial lung disease.
- Inadequate bone marrow reserve or organ function.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
- Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
- Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
- Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.
Trial locations and contacts
139 sites in 20 countries.
139 sites in 20 countries
China26 sites
Research Site
Beijing, 100005
Research Site
Beijing, 100029
Research Site
Beijing, 100142
Research Site
Beijing, 100210
Research Site
Beijing, 100730
Research Site
Beijing, 102218
Research Site
Changchun, 130012
Research Site
Changsha, 410013
Research Site
Changsha, 430033
Research Site
Chengdu, 610000
Research Site
Fuzhou, 350014
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510100
Research Site
Hangzhou, 310022
Research Site
Harbin, 150049
Research Site
Jinan, 250117
Research Site
Nanjing, 210029
Research Site
Shanghai, 200030
Research Site
Shanghai, 200032
Research Site
Shenzhen, 518116
Research Site
Suzhou, 215006
Research Site
Taiyuan, 030000
Research Site
Xi'an, 710061
Research Site
Xintai, 54031
Research Site
Yangzhou, 225001
Research Site
Zhengzhou, 450008
United States15 sites
Research Site
Anchorage, Alaska, 99508
Research Site
Atlanta, Georgia, 30322
Research Site
Chicago, Illinois, 60612
Research Site
Flushing, New York, 11355
Research Site
Fort Belvoir, Virginia, 22060
Research Site
Frederick, Maryland, 21702
Research Site
Grand Junction, Colorado, 81501
Research Site
Houston, Texas, 77030
Research Site
Los Angeles, California, 90024
Research Site
Morristown, New Jersey, 07960
Research Site
New York, New York, 10032
Research Site
New York, New York, 10065
Research Site
Newark, Delaware, 19713
Research Site
Orange, California, 92868
Research Site
White Plains, New York, 10601
Japan13 sites
Research Site
Chiba, 260-0877
Research Site
Fukuoka, 812-8582
Research Site
Hiroshima, 734-8551
Research Site
Kashiwa, 227-8577
Research Site
Kōtoku, 135-8550
Research Site
Kyoto, 606-8507
Research Site
Niigata, 951-8566
Research Site
Osaka, 541-8567
Research Site
Sakai, 590-0197
Research Site
Sendai, 981-0914
Research Site
Shinjuku-ku, 160-0023
Research Site
Sunto-gun, 411-8777
Research Site
Wakayama, 641-8510
Italy9 sites
Research Site
Bari, 70124
Research Site
Catania, 95100
Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Parma, 43100
Research Site
Roma, 00144
Taiwan8 sites
Research Site
Taichung, 40201
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Taipei, 100
Research Site
Taipei, 11217
Research Site
Taipei, 114
Research Site
Taipei, 235
Research Site
Taoyuan, 333
Argentina7 sites
Research Site
Buenos Aires, C1431FWO
Research Site
CABA, C1012AAR
Research Site
Cipolletti, 8234
Research Site
La Plata, 1900
Research Site
Rosario, 2000
Research Site
Rosario, S2000CVB
Research Site
S.C. de Bariloche, 8400
Brazil7 sites
Research Site
Barretos, 14784-400
Research Site
Belo Horizonte, 30380-090
Research Site
Porto Alegre, 90610-000
Research Site
Recife, 52010-075
Research Site
Rio de Janeiro, 22271-110
Research Site
São Paulo, 01327-001
Research Site
São Paulo, 04501-000
South Korea7 sites
Research Site
Daegu, 42415
Research Site
Jinju, 52727
Research Site
Seoul, 03082
Research Site
Seoul, 05505
Research Site
Seoul, 07061
Research Site
Suwon, 16247
Research Site
Suwon, 16499
United Kingdom7 sites
Research Site
Birmingham, B9 5SS
Research Site
Blackpool, FY3 8NR
Research Site
London, SE1 9RT
Research Site
London, SW10 9NH
Research Site
London, SW3 6NP
Research Site
Nottingham, NG5 1PB
Research Site
Wythenshawe, M23 9LT
Germany6 sites
Research Site
Berlin, 13125
Research Site
Esslingen am Neckar, 73730
Research Site
Georgsmarienhütte, 49124
Research Site
Lübeck, 23538
Research Site
München, 81377
Research Site
Würzburg, 97067
Thailand6 sites
Research Site
Bangkok, 10300
Research Site
Bangkok, 10330
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Research Site
Muang, 50200
Spain5 sites
Research Site
Barcelona, 08041
Research Site
Málaga, 29010
Research Site
Valencia, 46010
Research Site
Vigo, 36312
Research Site
Zaragoza, 50009
Turkey (Türkiye)5 sites
Research Site
Ankara, 06010
Research Site
Bursa, 16059
Research Site
Istanbul
Research Site
Izmir, 35040
Research Site
Kadıkoy/Istanbul, 34722
Malaysia4 sites
Research Site
Kuala Lumpur, 59100
Research Site
Kuala Selangor, 46050
Research Site
Kuching, 93586
Research Site
Pulau Pinang, 10450
Canada3 sites
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Toronto, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 1M9
Vietnam3 sites
Research Site
Hanoi, 100000
Research Site
Hồ Chí Minh, 700000
Research Site
Ho Chi Minh City, 700000
Singapore2 sites
Research Site
Singapore, 169610
Research Site
Singapore, 308433
About this study
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
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Osimertinib, Placebo
- Keywords
- Osimertinib, Tagrisso, NSCLC, Non-small Cell Lung Cancer, Resectable, EGFRm Positive, Adjuvant, Stage IA2-IA3
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called AZD9291; TAGRISSO
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.
PlaceboDrug
Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib | Experimental | Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator) Receives: Drug: Osimertinib |
| Placebo | Placebo comparator | Matching placebo for osimertinib, orally, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) in high-risk stratum
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.
Measured: From date of randomisation up to approximately 10 years
Secondary outcomes (6)
Disease-Free Survival (DFS) in overall population
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.
Measured: From date of randomisation up to approximately 10 years
Overall Survival (OS) in high-risk stratum and the overall population
OS is defined as the time from the date of randomisation until death due to any cause.
Measured: From date of randomization up to approximately 10 years
PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population
Ratio of metabolite-to-osimertinib to be calculated at predose, and at 0.5-2 hours postdose.
Measured: From date of randomisation up to approximately 10 years
Impact of osimertinib versus placebo on physical functioning
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
Measured: 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
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.
Measured: From date of randomisation up to approximately 10 years
Safety and tolerability in overall population
AEs graded by CTCAE version 5.0
Measured: From date of randomisation up to approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start21 Feb 2022
- Primary completion2 Aug 2027 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Goldman, MD, Principal investigator, University of California, Los AngelesYasuhiro Tsutani, MD, PhD, Principal investigator, Kindai University Facility of MedicineJie He, MD, PhD, Principal investigator, The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120349
- Sponsor's protocol ID
- D516FC00001
- Other IDs
- 2023-509943-28, 2021-004135-89, 2023
- Acronym
- ADAURA2
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.
PubMed 40311309
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05120349
- Acronym / sponsor ID
- ADAURA2 / D516FC00001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Osimertinib, Tagrisso, NSCLC, Non-small Cell Lung Cancer, Resectable, EGFRm Positive, Adjuvant, Stage IA2-IA3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 2 Aug 2027 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osimertinib | Experimental | Drug: OsimertinibOsimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo for osimertinib, orally, once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, at least ≥ 18 years.
- NSCLC, of non-squamous histology.
- Stage IA2 or IA3 disease, based on TNM8 classification.
- Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
- 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.
Key exclusion criteria (14 listed)
- Mixed small cell and non-small cell cancer history.
- Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.
- 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.
- 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.
- Any of the following cardiac criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsimertinibAlso: AZD9291; TAGRISSOThe 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. | Drug | Osimertinib |
| PlaceboMatching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily. | Drug | Placebo |
Primary outcome
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.
6 secondary outcomes
Disease-Free Survival (DFS) in overall population
Time frame: 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
PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population
Time frame: 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
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
Safety and tolerability in overall population
Time frame: From date of randomisation up to approximately 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 40311309Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.
- Lung Cancer Study Locator details (for US)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Goldman, MD principal investigator
University of California, Los Angeles
Yasuhiro Tsutani, MD, PhD principal investigator
Kindai University Facility of Medicine
Jie He, MD, PhD principal investigator
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)
139 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osimertinib in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 139 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 139 sites in China, United States, Japan, Italy, Taiwan and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) in high-risk stratum (time frame: From date of randomisation up to approximately 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.