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
NCT ID: NCT04351555
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
358 participants
INTERVENTIONAL
2020-12-16
2029-06-13
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
DOUBLE
Osimertinib monotherapy arm will be open label, sponsor-blind.
Study Groups
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Arm 1: Placebo with platinum-based chemotherapy
Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Cisplatin
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Carboplatin
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Placebo
Oral
Pemetrexed
Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Arm 2: Osimertinib with platinum-based chemotherapy
Osimertinib 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)
Osimertinib
Oral
Cisplatin
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Carboplatin
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Pemetrexed
Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Arm 3: Osimertinib monotherapy
Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)
Osimertinib
Oral
Interventions
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Osimertinib
Oral
Cisplatin
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Carboplatin
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Placebo
Oral
Pemetrexed
Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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)
18 Years
100 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jamie Chaft, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering, USA
Masahiro Tsuboi, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center Hospital East, Japan
Walter Weder, MD
Role: PRINCIPAL_INVESTIGATOR
Thoraxchirurgie Bethanien, Switzerland
Locations
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Research Site
Duarte, California, United States
Research Site
Irvine, California, United States
Research Site
San Francisco, 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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Boston, Massachusetts, United States
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Lebanon, New Hampshire, United States
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Commack, New York, United States
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New York, New York, United States
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Houston, Texas, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Graz, , Austria
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Vienna, , Austria
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Barretos, , Brazil
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Fortaleza, , Brazil
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Jaú, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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Rio de Janeiro, , Brazil
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Santa Maria, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Panagyurishte, , Bulgaria
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Las Condes, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , 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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Nanchang, , China
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Nantong, , China
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Shandong, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Suzhou, , China
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Ürümqi, , China
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Wanzhou, , China
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Wenzhou, , China
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Xiamen, , China
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Yangzhou, , China
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Avignon, , France
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Bordeaux, , France
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Berlin, , Germany
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Bielefeld, , Germany
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Cologne, , Germany
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Esslingen a.N., , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Georgsmarienhütte, , Germany
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Halle, , Germany
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Oldenburg, , Germany
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Würzburg, , Germany
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Mumbai, , India
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Namakkal, , India
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New Delhi, , India
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Varanasi, , India
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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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Florence, , Italy
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Monza, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Rozzano, , Italy
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Varese, , Italy
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Akashi-shi, , Japan
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Bunkyō City, , Japan
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Chiba, , Japan
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Hiroshima, , Japan
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Kashiwa, , Japan
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Kōtoku, , Japan
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Kyoto, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sakaishi, , 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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Yokohama, , Japan
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Aguascalientes, , Mexico
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D.F, , Mexico
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Mexico City, , Mexico
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La Libertad, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Olsztyn, , Poland
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Kazan', , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Obninsk, , Russia
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Perm, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Daegu, , South Korea
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Hwasun-gun, , South Korea
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Incheon, , 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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Yangsan, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Winterthur, , Switzerland
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Zurich, , Switzerland
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Pathum Thani, , Thailand
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Phisanulok, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Liverpool, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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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.
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.
Lee 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.
Tsuboi 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.
Other Identifiers
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2022-502606-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-000058-89
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D516AC00001
Identifier Type: -
Identifier Source: org_study_id
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