AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
NCT ID: NCT02511106
Last Updated: 2026-01-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
682 participants
INTERVENTIONAL
2015-10-21
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD9291
AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
AZD9291 80 mg/40 mg
The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Open-label AZD9291 80 mg/40 mg
Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.
Placebo AZD9291
Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Placebo AZD9291 80 mg/40 mg
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Interventions
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AZD9291 80 mg/40 mg
The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Placebo AZD9291 80 mg/40 mg
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Open-label AZD9291 80 mg/40 mg
Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
5. 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.
6. 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.
7. Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
8. World Health Organization Performance Status of 0 to 1.
9. 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.
Exclusion Criteria
* 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
* 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.
2. Patients who have had only segmentectomies or wedge resections
3. 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.
4. 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.
5. 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).
6. 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.
7. 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.
8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
9. Inadequate bone marrow reserve or organ function.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
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Santa Monica, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Grand Junction, Colorado, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, United States
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Fort Myers, Florida, United States
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Pembroke Pines, Florida, United States
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St. Petersburg, Florida, United States
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Athens, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Bethesda, Maryland, United States
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Brick, New Jersey, United States
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Florham Park, New Jersey, United States
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Mineola, New York, United States
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Pawtucket, Rhode Island, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, United States
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Fort Belvoir, Virginia, United States
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Bedford Park, , Australia
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Camperdown, , Australia
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Darlinghurst, , Australia
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Heidelberg, , Australia
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Kogarah, , Australia
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Kurralta Park, , Australia
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Woolloongabba, , Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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Barretos, , Brazil
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Cachoeira de Itapemirim, , Brazil
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Curitiba, , Brazil
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Lajeado, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Toronto, Ontario, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changchun, , China
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Dalian, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Kunming, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Suzhou, , China
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Tianjin, , China
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Tianjin, , China
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Tianjin, , China
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Ürümqi, , China
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Xi'an, , China
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Xiamen, , China
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Yangzhou, , China
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Zhengzhou, , China
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Bron, , France
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Lille, , France
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Limoges, , France
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Lyon, , France
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Paris, , France
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Aachen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Coswig, , Germany
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Gauting, , Germany
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Gerlingen, , Germany
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Großhansdorf, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Homburg, , Germany
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Immenhausen, , Germany
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Kassel, , Germany
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Lübeck, , Germany
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Würzburg, , Germany
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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King's Park, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Székesfehérvár, , Hungary
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Törökbálint, , Hungary
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bari, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Cremona, , Italy
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Florence, , Italy
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Parma, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Hirakata-shi, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Kanazawa, , Japan
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Kashiwa, , Japan
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Kitakyushu-shi, , Japan
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Kobe, , Japan
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Kurume-shi, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osakasayama-shi, , Japan
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Sagamihara-shi, , Japan
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Sakaishi, , Japan
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Sasebo-shi, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Ube-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yonago-shi, , Japan
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Hoofddorp, , Netherlands
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Zwolle, , Netherlands
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Krakow, , Poland
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Lodz, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Racibórz, , Poland
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Warsaw, , Poland
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Wieliszew, , Poland
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Focşani, , Romania
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Iași, , Romania
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Timișoara, , Romania
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Arkhangelsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Obninsk, , Russia
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Omsk, , Russia
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Pyatigorsk, , Russia
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Rostov-on-Don, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Cheongju-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Suwon, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Elche, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Linköping, , Sweden
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Changhua, , Taiwan
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Putzu City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Rai, , Thailand
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Khon Kaen, , Thailand
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Mueang, , Thailand
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Phitsanulok, , Thailand
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Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Dnipro, , Ukraine
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Lviv, , Ukraine
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Sumy, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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EGFR mutation
Stage IB non-small cell lung cancer
Stage II non-small cell lung cancer
Stage IIIA non-small cell lung cancer
Adjuvant chemotherapy in non-small cancer
Complete tumour resection in non-small cancer
EGFR sensitivity
EGFR inhibitors
FDA Drug and Device Resources
Other Identifiers
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2023-506524-82-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-000662-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5164C00001
Identifier Type: -
Identifier Source: org_study_id
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