AzTrials
AzTrials

Stage IB-IIIA Non-small Cell Lung CarcinomaPhase 3ADAURANCT02511106

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

A Phase 3 study testing AZD9291 80 mg/40 mg and Open-label AZD9291 80 mg/40 mg in people with Stage IB-IIIA Non-small Cell Lung Carcinoma, run by AstraZeneca at 238 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy Read more about this study

Who is it for?
Ages 18 to 130 years
What is being tested?
AZD9291 80 mg/40 mg and Open-label AZD9291 80 mg/40 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
682 participants
Where
238 sitesin 25 countries
Study dates
21 Oct 2015to 31 Jan 2029
Phase
Phase 3

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 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged at least 18 years.
  • Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
  • MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
  • Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
  • Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
  • Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
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  • Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
  • World Health Organization Performance Status of 0 to 1.
  • Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.

Who cannot join

  • Treatment with any of the following:
  • Pre-operative or post-operative or planned radiation therapy for the current lung cancer
  • Pre-operative (neo-adjuvant) platinum based or other chemotherapy
  • Any prior anticancer therapy
  • Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
  • Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug
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  • Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
  • Treatment with an investigational drug within five half-lives of the compound or any of its related material.
  • Patients who have had only segmentectomies or wedge resections
  • History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
  • Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
  • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  • Inadequate bone marrow reserve or organ function.

Trial locations and contacts

238 sites in 25 countries.

238 sites in 25 countries

China29 sites
  • Research Site

    Beijing, 100029

  • Research Site

    Beijing, 100142

  • Research Site

    Beijing, 100210

  • Research Site

    Beijing, 100730

  • Research Site

    Changchun, 130012

  • Research Site

    Changchun, 130021

  • Research Site

    Dalian, 116027

  • Research Site

    Guangzhou, 510060

  • Research Site

    Guangzhou, 510120

  • Research Site

    Guangzhou, 510180

  • Research Site

    Hangzhou, 310003

  • Research Site

    Hangzhou, 310009

  • Research Site

    Hangzhou, 310022

  • Research Site

    Kunming, 650118

  • Research Site

    Nanjing, 210029

  • Research Site

    Nanning, 530021

  • Research Site

    Shanghai, 200030

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 200072

  • Research Site

    Shenyang, 110001

  • Research Site

    Suzhou, 215006

  • Research Site

    Tianjin, 300050

  • Research Site

    Tianjin, 300051

  • Research Site

    Tianjin, 300060

  • Research Site

    Ürümqi, 830000

  • Research Site

    Xi'an, 710061

  • Research Site

    Xiamen, 361004

  • Research Site

    Yangzhou, 225001

  • Research Site

    Zhengzhou, 450008

Other trials in China

Japan24 sites
  • Research Site

    Bunkyō City, 113-8431

  • Research Site

    Fukuoka, 812-8582

  • Research Site

    Hirakata-shi, 573-1191

  • Research Site

    Hiroshima, 730-8518

  • Research Site

    Hiroshima, 734-8551

  • Research Site

    Kanazawa, 920-8641

  • Research Site

    Kashiwa, 277-8577

  • Research Site

    Kitakyushu-shi, 807-8555

  • Research Site

    Kobe, 650-0047

  • Research Site

    Kurume-shi, 830-0011

  • Research Site

    Matsuyama, 791-0280

  • Research Site

    Nagoya, 453-8511

  • Research Site

    Niigata, 951-8566

  • Research Site

    Osakasayama-shi, 589-8511

  • Research Site

    Sagamihara-shi, 252-0375

  • Research Site

    Sakaishi, 591-8555

  • Research Site

    Sasebo-shi, 857-8511

  • Research Site

    Sendai, 980-0873

  • Research Site

    Shinjuku-ku, 160-0023

  • Research Site

    Sunto-gun, 411-8777

  • Research Site

    Ube-shi, 755-0241

  • Research Site

    Yokohama, 240-8555

  • Research Site

    Yokohama, 241-8515

  • Research Site

    Yonago-shi, 683-8504

Other trials in Japan

United States23 sites
  • Research Site

    Athens, Georgia, 30607

  • Research Site

    Bethesda, Maryland, 20817

  • Research Site

    Brick, New Jersey, 08724

  • Research Site

    Chattanooga, Tennessee, 37404

  • Research Site

    Chicago, Illinois, 60612

  • Research Site

    Elk Grove Village, Illinois, 60007

  • Research Site

    Florham Park, New Jersey, 07932

  • Research Site

    Fort Belvoir, Virginia, 22060

  • Research Site

    Fort Myers, Florida, 33901

  • Research Site

    Grand Junction, Colorado, 81501

  • Research Site

    Honolulu, Hawaii, 96819

  • Research Site

    Los Angeles, California, 90048

  • Research Site

    Mineola, New York, 11501

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    New Haven, Connecticut, 06520

  • Research Site

    Norwalk, Connecticut, 06856

  • Research Site

    Pawtucket, Rhode Island, 02860

  • Research Site

    Pembroke Pines, Florida, 33028

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    Santa Monica, California, 90404

  • Research Site

    Santa Rosa, California, 95403

  • Research Site

    St. Petersburg, Florida, 33705

  • Research Site

    Torrance, California, 90505

Other trials in United States

Germany16 sites
  • Research Site

    Aachen, 52074

  • Research Site

    Berlin, 12351

  • Research Site

    Berlin, 13125

  • Research Site

    Berlin, 13359

  • Research Site

    Cologne, 51109

  • Research Site

    Coswig, 01640

  • Research Site

    Gauting, 82131

  • Research Site

    Gerlingen, 70839

  • Research Site

    Großhansdorf, 22927

  • Research Site

    Halle, 06120

  • Research Site

    Hamburg, 20251

  • Research Site

    Homburg, 66421

  • Research Site

    Immenhausen, 34376

  • Research Site

    Kassel, 34125

  • Research Site

    Lübeck, 23538

  • Research Site

    Würzburg, 97074

Other trials in Germany

Italy15 sites
  • Research Site

    Bari, 70124

  • Research Site

    Bergamo, 24127

  • Research Site

    Bologna, 40138

  • Research Site

    Cremona, 26100

  • Research Site

    Florence, 50134

  • Research Site

    Lucca, 55100

  • Research Site

    Meldola, 47014

  • Research Site

    Milan, 20132

  • Research Site

    Milan, 20141

  • Research Site

    Milan, 20162

  • Research Site

    Novara, 28100

  • Research Site

    Orbassano, 10043

  • Research Site

    Padova, 35128

  • Research Site

    Parma, 43126

  • Research Site

    Roma, 00152

Other trials in Italy

Russia14 sites
  • Research Site

    Arkhangelsk, 163045

  • Research Site

    Kazan', 420029

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 143423

  • Research Site

    Obninsk, 249036

  • Research Site

    Omsk, 644013

  • Research Site

    Pyatigorsk, 357502

  • Research Site

    Rostov-on-Don, 344037

  • Research Site

    Ryazan, 390011

  • Research Site

    Saint Petersburg, 194291

  • Research Site

    Saint Petersburg, 195271

  • Research Site

    Saint Petersburg, 197022

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Saint Petersburg, 198255

Other trials in Russia

Spain14 sites
  • Research Site

    A Coruña, 15006

  • Research Site

    Barcelona, 08041

  • Research Site

    Donostia / San Sebastian, 20014

  • Research Site

    Elche, 03203

  • Research Site

    Las Palmas de Gran Canaria, 35016

  • Research Site

    Madrid, 08035

  • Research Site

    Madrid, 28007

  • Research Site

    Madrid, 28040

  • Research Site

    Madrid, 28046

  • Research Site

    Majadahonda, 28222

  • Research Site

    Málaga, 29010

  • Research Site

    Valencia, 46010

  • Research Site

    Valencia, 46026

  • Research Site

    Zaragoza, 50009

Other trials in Spain

Brazil11 sites
  • Research Site

    Barretos, 14784-400

  • Research Site

    Cachoeira de Itapemirim, 29308-055

  • Research Site

    Curitiba, 81520-060

  • Research Site

    Florianópolis, 88034-000

  • Research Site

    Fortaleza, 60810-180

  • Research Site

    Lajeado, 95900000

  • Research Site

    Porto Alegre, 90619-900

  • Research Site

    Rio de Janeiro, 22793-080

  • Research Site

    Salvador, 40170-110

  • Research Site

    São José do Rio Preto, 15025-100

  • Research Site

    São Paulo, 01321-001

Other trials in Brazil

Taiwan9 sites
  • Research Site

    Changhua, 50006

  • Research Site

    Putzu City, 0613

  • Research Site

    Taichung, 402

  • Research Site

    Taichung, 40705

  • Research Site

    Tainan, 70403

  • Research Site

    Tainan, 73657

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 112

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

South Korea8 sites
  • Research Site

    Cheongju-si, 28644

  • Research Site

    Seoul, 02841

  • Research Site

    Seoul, 05030

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 07061

  • Research Site

    Suwon, 16247

  • Research Site

    Suwon, 16499

Other trials in South Korea

Turkey (Türkiye)8 sites
  • Research Site

    Ankara, 06280

  • Research Site

    Ankara, 6500

  • Research Site

    Bursa, 16059

  • Research Site

    Istanbul, 34069

  • Research Site

    Istanbul, 34093

  • Research Site

    Istanbul, 34098

  • Research Site

    Istanbul, 34722

  • Research Site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Australia7 sites
  • Research Site

    Bedford Park, 5042

  • Research Site

    Camperdown, 2050

  • Research Site

    Darlinghurst, 2010

  • Research Site

    Heidelberg, 3084

  • Research Site

    Kogarah, 2217

  • Research Site

    Kurralta Park, 5037

  • Research Site

    Woolloongabba, 4102

Other trials in Australia

Israel7 sites
  • Research Site

    Beersheba, 8410101

  • Research Site

    Haifa, 31999

  • Research Site

    Jerusalem, 91120

  • Research Site

    Kfar Saba, 4428164

  • Research Site

    Petah Tikva, 4941492

  • Research Site

    Ramat Gan, 5262000

  • Research Site

    Tel Aviv, 6423906

Other trials in Israel

Poland7 sites
  • Research Site

    Krakow, 31-202

  • Research Site

    Lodz, 90-302

  • Research Site

    Otwock, 05-400

  • Research Site

    Poznan, 60-569

  • Research Site

    Racibórz, 47-400

  • Research Site

    Warsaw, 02-781

  • Research Site

    Wieliszew, 05-135

Other trials in Poland

Romania7 sites
  • Research Site

    Bucharest, 031422

  • Research Site

    Bucharest, 050098

  • Research Site

    Cluj-Napoca, 400015

  • Research Site

    Craiova, 200385

  • Research Site

    Focşani, 620165

  • Research Site

    Iași, 700483

  • Research Site

    Timișoara, 300210

Other trials in Romania

Thailand7 sites
  • Research Site

    Bangkok, 10330

  • Research Site

    Bangkok, 10700

  • Research Site

    Chiang Rai, 57000

  • Research Site

    Khon Kaen, 40002

  • Research Site

    Mueang, 50200

  • Research Site

    Phitsanulok, 65000

  • Research Site

    Songkhla, 90110

Other trials in Thailand

Ukraine6 sites
  • Research Site

    Dnipro, 49102

  • Research Site

    Lviv, 79031

  • Research Site

    Sumy, 40022

  • Research Site

    Uzhhorod, 88000

  • Research Site

    Vinnytsia, 21029

  • Research Site

    Zaporizhzhya, 69040

Other trials in Ukraine

France5 sites
  • Research Site

    Bron, 69677

  • Research Site

    Lille, 59000

  • Research Site

    Limoges, 87042

  • Research Site

    Lyon, 69008

  • Research Site

    Paris, 75020

Other trials in France

Hungary5 sites
  • Research Site

    Budapest, 1083

  • Research Site

    Budapest, 1121

  • Research Site

    Deszk, 6772

  • Research Site

    Székesfehérvár, 8000

  • Research Site

    Törökbálint, 2045

Other trials in Hungary

Belgium4 sites
  • Research Site

    Brussels, 1090

  • Research Site

    Brussels, 1200

  • Research Site

    Ghent, 9000

  • Research Site

    Kortrijk, 8500

Other trials in Belgium

Netherlands4 sites
  • Research Site

    Amsterdam, 1081 HV

  • Research Site

    Arnhem, 6815 AD

  • Research Site

    Hoofddorp, 2134 TM

  • Research Site

    Zwolle, 8025 AB

Other trials in Netherlands

Hong Kong3 sites
  • Research Site

    Hong Kong, 150001

  • Research Site

    Hong Kong

  • Research Site

    King's Park, 150001

Other trials in Hong Kong

Vietnam3 sites
  • Research Site

    Hanoi, 100000

  • Research Site

    Hanoi, 10000

  • Research Site

    Ho Chi Minh City, 70000

Other trials in Vietnam

Canada1 site
  • Research Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Sweden1 site
  • Research Site

    Linköping, 581 85

Other trials in Sweden

About this study

Official title: A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

Read the detailed description

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of AZD9291 versus placebo in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy. Adjuvant chemotherapy should have consisted of a platinum based doublet given for a maximum of 4 cycles.

Being tested
AZD9291 80 mg/40 mg, Placebo AZD9291 80 mg/40 mg, Open-label AZD9291 80 mg/40 mg
Keywords
Stage IB-IIA-IIIA Non-Small Cell Lung Cancer; EGFRm+; Ex19Del; L858R; AZD9291; Phase III, adjuvant chemotherapy; complete tumour resection; EGFR-TKI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD9291 80 mg/40 mgDrug

    The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.

  • Placebo AZD9291 80 mg/40 mgDrug

    The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.

  • Open-label AZD9291 80 mg/40 mgDrug

    Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.

Study groups in NCT02511106
Study groupRoleWhat they receive
AZD9291ExperimentalAZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Receives: Drug: AZD9291 80 mg/40 mg; Drug: Open-label AZD9291 80 mg/40 mg
Placebo AZD9291Placebo comparatorMatching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Receives: Drug: Placebo AZD9291 80 mg/40 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).

    Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).

    Measured: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)

Secondary outcomes (7)
  1. Disease Free Survival (DFS) Rate at 2, 3 and 5 Years

    Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS.

    Measured: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.

  2. Overall Survival (OS)

    Defined as the time from the date of randomization until date of death due to any cause.

    Measured: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)

  3. Overall Survival Rate at 2, 3 and 5 Years

    Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS.

    Measured: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.

  4. Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.

    Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.

    Measured: Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.

  5. Plasma Concentrations of AZD9291

    The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291

    Measured: Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)

  6. Plasma Concentrations of AZ5104 Metabolites

    The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites

    Measured: From date of dosing to week 96 (approximately 24 months)

  7. Plasma Concentrations of AZ7550 Metabolites

    The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites

    Measured: From date of dosing to week 96 (approximately 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2015 (estimated)
  2. Study start21 Oct 2015
  3. Primary completion11 Apr 2022
  4. Study completion31 Jan 2029 (estimated)

Resources

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, Investigator, Outcomes assessor
Enrolment
682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02511106
Sponsor's protocol ID
D5164C00001
Other IDs
2023-506524-82-00, 2015-000662-65, 2015, 2023
Acronym
ADAURA
Status last verified
Sep 2026
First submitted
28 Jul 2015
Last updated
11 Sep 2026
Data monitoring committee
Yes
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

  • Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951. No abstract available.

    PubMed 33596365
  • Wu YL, Majem M, John T, Grohe C, Wang J, Goldman JW, Lu S, Shepherd FA, Wang Q, Kato T, Aokage K, Zhong WZ, Laktionov K, Wu MF, Akewanlop C, Vu HV, Lee KH, Huang X, Armenteros-Monterroso E, Rukazenkov Y, Herbst RS. Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB-IIIA Non-Small Cell Lung Cancer: Exploratory 8-year Overall Survival Landmark Update from the ADAURA Trial [161/175]. J Thorac Oncol. 2026 Sep 13:104179. doi: 10.1016/j.jtho.2026.104179. Online ahead of print.

    PubMed 42732874
  • 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
  • Herbst RS, John T, Grohe C, Goldman JW, Kato T, Laktionov K, Bonanno L, Tiseo M, Majem M, Domine M, Ahn MJ, Kowalski DM, Perol M, Sriuranpong V, Ozguroglu M, Bhetariya P, Markovets A, Rukazenkov Y, Muldoon C, Robichaux J, Hartmaier R, Tsuboi M, Wu YL. Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer. Nat Med. 2025 Jun;31(6):1958-1968. doi: 10.1038/s41591-025-03577-y. Epub 2025 Mar 17.

    PubMed 40097663
  • Dwyer LJ, Singhal N, Yu B, Kao S. Successful Osimertinib Rechallenge After Relapse Following Adjuvant Osimertinib: A Case Report. J Thorac Oncol. 2024 Apr;19(4):650-652. doi: 10.1016/j.jtho.2024.01.001. Epub 2024 Feb 9.

    PubMed 38340108
  • Wu D, Li GF. Improving Report of the ADAURA Trial by Distinguishing Treatment-Related Adverse Events From Treatment-Emergent Adverse Events and Assessing Independence of Censoring in Final Disease-Free Survival Analyses. J Clin Oncol. 2023 Sep 10;41(26):4317-4318. doi: 10.1200/JCO.23.00604. Epub 2023 Jun 30. No abstract available.

    PubMed 37390376
  • Tsuboi M, Herbst RS, John T, Kato T, Majem M, Grohe C, Wang J, Goldman JW, Lu S, Su WC, de Marinis F, Shepherd FA, Lee KH, Le NT, Dechaphunkul A, Kowalski D, Poole L, Bolanos A, Rukazenkov Y, Wu YL; ADAURA Investigators. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023 Jul 13;389(2):137-147. doi: 10.1056/NEJMoa2304594. Epub 2023 Jun 4.

    PubMed 37272535
  • John T, Grohe C, Goldman JW, Shepherd FA, de Marinis F, Kato T, Wang Q, Su WC, Choi JH, Sriuranpong V, Melotti B, Fidler MJ, Chen J, Albayaty M, Stachowiak M, Taggart S, Wu YL, Tsuboi M, Herbst RS, Majem M. Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial. J Thorac Oncol. 2023 Sep;18(9):1209-1221. doi: 10.1016/j.jtho.2023.05.015. Epub 2023 May 24.

    PubMed 37236398
  • Herbst RS, Wu YL, John T, Grohe C, Majem M, Wang J, Kato T, Goldman JW, Laktionov K, Kim SW, Yu CJ, Vu HV, Lu S, Lee KY, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd FA, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. J Clin Oncol. 2023 Apr 1;41(10):1830-1840. doi: 10.1200/JCO.22.02186. Epub 2023 Jan 31.

    PubMed 36720083
  • John T, Majem M, Legg D, Goldman J. Current and Future Perspectives of Health-Related Quality of Life in Resectable EGFR-Mutated Non-Small Cell Lung Cancer: A Podcast. Target Oncol. 2023 Jan;18(1):1-8. doi: 10.1007/s11523-022-00927-5. Epub 2022 Dec 19. No abstract available.

    PubMed 36534268
  • Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.

    PubMed 35012927
  • Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. J Thorac Oncol. 2022 Mar;17(3):423-433. doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.

    PubMed 34740861
  • Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.

    PubMed 34723634
  • Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.

    PubMed 32955177
  • Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.

    PubMed 29789220

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