A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
ADAURA2
A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib Versus Placebo in Participants With EGFR Mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, Following Complete Tumour Resection
3 other identifiers
interventional
390
20 countries
139
Brief Summary
This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.
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 Feb 2022
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
139 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
November 3, 2021
CompletedFirst Posted
Study publicly available on registry
November 15, 2021
CompletedStudy Start
First participant enrolled
February 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2032
April 23, 2026
April 1, 2026
5.4 years
November 3, 2021
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival (DFS) in high-risk stratum
DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first. Stratification to the high risk stratum will be based on pathologic features assessed by central pathology review during screening.
From date of randomisation up to approximately 10 years
Secondary Outcomes (6)
Disease-Free Survival (DFS) in overall population
From date of randomisation up to approximately 10 years
Overall Survival (OS) in high-risk stratum and the overall population
From date of randomization up to approximately 10 years
PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population
From date of randomisation up to approximately 10 years
Impact of osimertinib versus placebo on physical functioning
From date of randomisation up to approximately 10 years
Central Nervous System (CNS) Disease-Free Survival (DFS) in both the high-risk stratum and the overall population
From date of randomisation up to approximately 10 years
- +1 more secondary outcomes
Study Arms (2)
Osimertinib
EXPERIMENTALOsimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)
Placebo
PLACEBO COMPARATORMatching placebo for osimertinib, orally, once daily
Interventions
The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease recurrence, unacceptable toxicity or other discontinuation criteria are met.
Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.
Eligibility Criteria
You may qualify if:
- Male or female, at least ≥ 18 years.
- NSCLC, of non-squamous histology.
- Stage IA2 or IA3 disease, based on TNM8 classification.
- Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy, segmentectomy or sleeve resection.
- Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
- World Health Organization performance status of 0 or 1.
- Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
- A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.
- Minimum life expectancy of \> 6 months.
- Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.
You may not qualify if:
- Mixed small cell and non-small cell cancer history.
- Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or only wedge resection.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including HCV and HIV or active uncontrolled HBV infection.
- History of another primary malignancy, including any known or suspected synchronous primary lung cancer except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.
- Any of the following cardiac criteria:
- Mean resting QTcF interval \> 470 ms, obtained from triplicate ECGs performed at screening.
- Any abnormalities in rhythm, conduction, or morphology of resting ECG,
- Any factors that increase the risk of QTcF prolongation or risk of arrhythmic events.
- History of interstitial lung disease.
- Inadequate bone marrow reserve or organ function.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
- Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
- Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
- Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (139)
Research Site
Anchorage, Alaska, 99508, United States
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Los Angeles, California, 90024, United States
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Orange, California, 92868, United States
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Grand Junction, Colorado, 81501, United States
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Newark, Delaware, 19713, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60612, United States
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Frederick, Maryland, 21702, United States
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Morristown, New Jersey, 07960, United States
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Flushing, New York, 11355, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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White Plains, New York, 10601, United States
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Houston, Texas, 77030, United States
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Fort Belvoir, Virginia, 22060, United States
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Buenos Aires, C1431FWO, Argentina
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CABA, C1012AAR, Argentina
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Cipolletti, 8234, Argentina
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La Plata, 1900, Argentina
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Rosario, 2000, Argentina
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Rosario, S2000CVB, Argentina
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S.C. de Bariloche, 8400, Argentina
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30380-090, 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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São Paulo, 01327-001, Brazil
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São Paulo, 04501-000, Brazil
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Vancouver, British Columbia, V5Z 1M9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Toronto, M5G 2M9, Canada
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Beijing, 100005, China
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Beijing, 100029, China
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Beijing, 100142, China
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Beijing, 100210, China
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Beijing, 100730, China
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Beijing, 102218, China
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Changchun, 130012, China
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Changsha, 410013, China
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Changsha, 430033, China
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Chengdu, 610000, China
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Fuzhou, 350014, China
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Guangzhou, 510060, China
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Guangzhou, 510100, China
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Hangzhou, 310022, China
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Harbin, 150049, China
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Jinan, 250117, China
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Nanjing, 210029, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shenzhen, 518116, China
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Suzhou, 215006, China
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Taiyuan, 030000, China
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Xi'an, 710061, China
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Xintai, 54031, China
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Yangzhou, 225001, China
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Zhengzhou, 450008, China
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Berlin, 13125, Germany
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Esslingen am Neckar, 73730, Germany
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Georgsmarienhütte, 49124, Germany
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Lübeck, 23538, Germany
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München, 81377, Germany
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Würzburg, 97067, Germany
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Bari, 70124, Italy
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Catania, 95100, Italy
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Florence, 50134, Italy
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Genova, 16132, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Parma, 43100, Italy
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Roma, 00144, Italy
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Chiba, 260-0877, Japan
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Fukuoka, 812-8582, 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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Sakai, 590-0197, 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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Wakayama, 641-8510, Japan
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 46050, Malaysia
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Kuching, 93586, Malaysia
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Pulau Pinang, 10450, Malaysia
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Poznan, 60-569, Poland
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Warsaw, 01-138, Poland
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Bucharest, 022328, Romania
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Bucharest, 050098, Romania
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Perm, 614990, Russia
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Saint Petersburg, 191036, Russia
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Singapore, 169610, Singapore
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Singapore, 308433, Singapore
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Daegu, 42415, South Korea
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Jinju, 52727, South Korea
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Seoul, 03082, South Korea
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Seoul, 05505, South Korea
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Seoul, 07061, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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Barcelona, 08041, Spain
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Málaga, 29010, Spain
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Valencia, 46010, Spain
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Vigo, 36312, Spain
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Zaragoza, 50009, Spain
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Taichung, 40201, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Taipei, 235, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10300, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 50200, Thailand
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Ankara, 06010, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Kadıkoy/Istanbul, 34722, Turkey (Türkiye)
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Birmingham, B9 5SS, United Kingdom
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Blackpool, FY3 8NR, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW10 9NH, United Kingdom
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London, SW3 6NP, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Wythenshawe, M23 9LT, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hồ Chí Minh, 700000, Vietnam
Related Publications (1)
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.
PMID: 40311309DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Goldman, MD
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Yasuhiro Tsutani, MD, PhD
Kindai University Facility of Medicine
- PRINCIPAL INVESTIGATOR
Jie He, MD, PhD
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2021
First Posted
November 15, 2021
Study Start
February 21, 2022
Primary Completion (Estimated)
August 2, 2027
Study Completion (Estimated)
November 1, 2032
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- 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 refer to our disclosure commitment: 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.