A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
NeoADAURA
A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer
3 other identifiers
interventional
358
25 countries
158
Brief Summary
This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Dec 2020
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedStudy Start
First participant enrolled
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2029
ExpectedMay 23, 2025
May 1, 2025
3.8 years
April 1, 2020
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Pathological Response (MPR)
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery
From date of randomization to an average of 12 weeks after the first dose
Secondary Outcomes (10)
Pathological complete response (pCR)
From date of randomization to an average of 12 weeks after the first dose
Event-free survival (EFS)
From date of randomization up to approximately 5.5 years after the last patient is randomized
Overall Survival (OS)
From date of randomization up to approximately 5.5 years after the last patient is randomized
Disease free survival (DFS)
From date of randomization up to approximately 5.5 years after the last patient is randomized
Downstaging
From date of randomization to an average of 12 weeks after the first dose
- +5 more secondary outcomes
Other Outcomes (3)
Cure rate
From the surgery until 5 years after surgery
Number of adverse events as assessed by CTCAE 5.0 and other clinical variables for safety and tolerability profile of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy prior to surgery compared with chemotherapy alone
From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery
MPR using plasma-derived circulating-free tumour DNA (ctDNA)
From date of randomization to an average of 12 weeks after the first dose
Study Arms (3)
Arm 1: Placebo with platinum-based chemotherapy
PLACEBO COMPARATORPlacebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Arm 2: Osimertinib with platinum-based chemotherapy
EXPERIMENTALOsimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator) plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Arm 3: Osimertinib monotherapy
EXPERIMENTALOsimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)
Interventions
Oral
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Eligibility Criteria
You may qualify if:
- Male or female, at least 18 years of age. For patients aged \<20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
- Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual \[IASLC Staging Manual in Thoracic Oncology 2016\]).
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
- A tumour which 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 (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q).
You may not qualify if:
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- History of another primary malignancy (including any known or suspected synchronous primary lung cancer), except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease; Any synchronous Stage IA primary lung cancer that is ≤2 cm and planned to be resected during surgery for the Stage II to IIIB N2 lung tumour.
- Patients who have pre-operative radiotherapy treatment as part of their care plan
- Mixed small cell and NSCLC histology
- Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC
- T4 tumours infiltrating the great vessels, the carina, the trachea, the oesophagus, the heart, and/or the vertebral body; and/or any bulky N2 disease.
- Patients who are candidates to undergo only segmentectomies or wedge resections
- Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
- Prior treatment with EGFR-TKI therapy
- Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (158)
Research Site
Duarte, California, 91010, United States
Research Site
Irvine, California, 92618, United States
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San Francisco, California, 94143, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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Boston, Massachusetts, 02215, United States
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Lebanon, New Hampshire, 03756, United States
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Commack, New York, 11725, United States
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New York, New York, 10032, United States
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Houston, Texas, 77030, United States
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Fairfax, Virginia, 22031, United States
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Seattle, Washington, 98104, United States
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Graz, 8036, Austria
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Vienna, 1210, Austria
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Barretos, 14784-400, Brazil
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Fortaleza, 60135-040, Brazil
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Jaú, 17204310, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 90610-000, Brazil
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Recife, 52010-075, Brazil
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Rio de Janeiro, 22271-110, Brazil
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Santa Maria, 97015-450, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 04038-034, Brazil
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São Paulo, 04501-000, Brazil
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Panagyurishte, 4500, Bulgaria
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Pleven, 5804, Bulgaria
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Sofia, 1113, Bulgaria
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Toronto, Ontario, M5G 2N2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Las Condes, 7560908, Chile
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Santiago, 7500713, Chile
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Santiago, 7500921, Chile
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Beijing, 100142, China
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Beijing, 100191, China
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Beijing, CN-100730, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400037, China
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Guangzhou, 510062, China
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Guangzhou, 510095, China
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Guangzhou, 510120, China
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Guangzhou, 510515, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Kunming, 650118, China
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Nanchang, 330006, China
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Nantong, 226001, China
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Shandong, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Suzhou, 215006, China
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Ürümqi, 830000, China
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Wanzhou, 404000, China
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Wenzhou, CN-325000, China
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Xiamen, 361004, China
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Yangzhou, 225001, China
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Avignon, 84902, France
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Bordeaux, 33000, France
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Berlin, 12351, Germany
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Bielefeld, 33611, Germany
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Cologne, 51109, Germany
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Esslingen a.N., 73730, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Georgsmarienhütte, 49124, Germany
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Halle, 06120, Germany
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Oldenburg, 26121, Germany
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Würzburg, 97067, Germany
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Mumbai, 400012, India
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Namakkal, 637001, India
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New Delhi, 110029, India
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Varanasi, 221005, India
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Haifa, 3109601, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 95847, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 5265601, Israel
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Tel Aviv, 62748, Israel
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Bari, 70124, Italy
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Florence, 50134, Italy
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Monza, 20900, Italy
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Orbassano, 10043, Italy
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Padua, 35128, Italy
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Rozzano, 20089, Italy
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Varese, 21100, Italy
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Akashi-shi, 673-8558, Japan
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Bunkyō City, 113-8431, Japan
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Chiba, 260-8677, Japan
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Hiroshima, 734-8551, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Kyoto, 606-8507, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
Research Site
Sakaishi, 591-8555, Japan
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Sendai, 981-0914, Japan
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Shinjuku-ku, 160-0023, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 241-8515, Japan
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Aguascalientes, 20230, Mexico
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D.F, 14050, Mexico
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Mexico City, '14080, Mexico
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La Libertad, 13013, Peru
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Lima, 0051, Peru
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Lima, 15036, Peru
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Lima, L41, Peru
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Lima, LIMA 34, Peru
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Olsztyn, 10-357, Poland
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Kazan', 420029, Russia
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Krasnoyarsk, 660133, Russia
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Moscow, 105229, Russia
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Nizhny Novgorod, 603081, Russia
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Obninsk, 249036, Russia
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Perm, 614990, Russia
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Saint Petersburg, 191036, Russia
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Saint Petersburg, 197758, Russia
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Daegu, 41404, South Korea
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Hwasun-gun, 58128, South Korea
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Incheon, 21431, South Korea
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Seoul, 02447, South Korea
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Seoul, 08308, South Korea
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Seoul, 42601, South Korea
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Yangsan, 50612, South Korea
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Barcelona, 08035, Spain
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Madrid, 28040, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Winterthur, 8401, Switzerland
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Zurich, CH-8091, Switzerland
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Taichung, 40201, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 112, Taiwan
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Taipei, 235, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Khon Kaen, 40002, Thailand
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Pathum Thani, 12120, Thailand
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Phisanulok, 65000, Thailand
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Ankara, 6500, Turkey (Türkiye)
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Istanbul, 34010, Turkey (Türkiye)
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Istanbul, 34214, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Birmingham, B9 5SS, United Kingdom
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Liverpool, L7 8YA, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 70000, Vietnam
Related Publications (4)
He J, Tsuboi M, Weder W, Chen KN, Hochmair MJ, Shih JY, Lee SY, Lee KY, Nhung NV, Saeteng S, Liu L, Xing L, Gia NH, Murakami S, Han Y, Saavedra MP, Yoon SH, Teixeira CHA, Escriu C, Martinez-Marti A, Blakely CM, Yatabe Y, Dacic S, Rukazenkov Y, Huang X, Dayal A, Chaft JE; NeoADAURA Investigators. Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small Cell Lung Cancer. J Clin Oncol. 2025 Sep 10;43(26):2875-2887. doi: 10.1200/JCO-25-00883. Epub 2025 Jun 2.
PMID: 40454705DERIVEDMurat-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.
PMID: 40311309DERIVEDLee JB, Choi SJ, Shim HS, Park BJ, Lee CY, Sudhaman S, Velichko S, Hong MH, Cho BC, Lim SM. Neoadjuvant and Adjuvant Osimertinib in Stage IA to IIIA, EGFR-Mutant NSCLC (NORA). J Thorac Oncol. 2025 May;20(5):641-650. doi: 10.1016/j.jtho.2024.12.023. Epub 2024 Dec 26.
PMID: 39732365DERIVEDTsuboi M, Weder W, Escriu C, Blakely C, He J, Dacic S, Yatabe Y, Zeng L, Walding A, Chaft JE. Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable non-small-cell lung cancer: NeoADAURA. Future Oncol. 2021 Nov;17(31):4045-4055. doi: 10.2217/fon-2021-0549. Epub 2021 Jul 19.
PMID: 34278827DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Chaft, MD
Memorial Sloan Kettering, USA
- PRINCIPAL INVESTIGATOR
Masahiro Tsuboi, MD
National Cancer Center Hospital East, Japan
- PRINCIPAL INVESTIGATOR
Walter Weder, MD
Thoraxchirurgie Bethanien, Switzerland
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The two arms with SoC chemotherapy (placebo plus chemotherapy versus osimertinib plus chemotherapy) will be double-blinded and placebo-controlled. Osimertinib monotherapy arm will be open label, sponsor-blind.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 17, 2020
Study Start
December 16, 2020
Primary Completion
October 15, 2024
Study Completion (Estimated)
June 13, 2029
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- 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.
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.