Back to resultsA Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection (ADAURA2)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Osimertinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Osimertinib, Tagrisso, NSCLC, Non-small Cell Lung Cancer, Resectable, EGFRm Positive, Adjuvant, Stage IA2-IA3
Eligibility Criteria
Inclusion Criteria
- 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, 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.
Exclusion Criteria
- Mixed small cell and non-small cell cancer history.
- Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy, bilobectomy or only wedge resection.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and HIV.
- History of another primary malignancy 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 QTc 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 QTc 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Osimertinib
Placebo
Arm Description
Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)
Matching placebo for osimertinib, orally, once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Disease-Free Survival (DFS) in overall population
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.
Overall Survival (OS) in high-risk stratum and the overall population
OS is defined as the time from the date of randomisation until death due to any cause.
PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population
Ratio of metabolite-to-osimertinib to be calculated at predose, and at 0.5-2 hours postdose.
Impact of osimertinib versus placebo on physical functioning
Assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and the overall population as measured by SF-36 V2 health survey
Central Nervous System (CNS) Disease-Free Survival (DFS) in both the high-risk stratum and the overall population
CNS DFS is defined as the time from randomisation to the time of a CNS lesion (as assessed by investigator) or death due to any cause, regardless of whether the participant withdraws from study intervention or receives other anti-cancer therapy.
Safety and tolerability in overall population
AEs graded by CTCAE version 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05120349
Brief Title
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
Acronym
ADAURA2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
August 2, 2027 (Anticipated)
Study Completion Date
November 1, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour resection. All participants must have had a tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).
Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms: osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria is met.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Osimertinib, Tagrisso, NSCLC, Non-small Cell Lung Cancer, Resectable, EGFRm Positive, Adjuvant, Stage IA2-IA3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osimertinib
Arm Type
Experimental
Arm Description
Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo for osimertinib, orally, once daily
Intervention Type
Drug
Intervention Name(s)
Osimertinib
Other Intervention Name(s)
AZD9291; TAGRISSO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.
Primary Outcome Measure Information:
Title
Disease-Free Survival (DFS) in high-risk stratum
Description
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.
Time Frame
From date of randomisation up to approximately 10 years
Secondary Outcome Measure Information:
Title
Disease-Free Survival (DFS) in overall population
Description
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.
Time Frame
From date of randomisation up to approximately 10 years
Title
Overall Survival (OS) in high-risk stratum and the overall population
Description
OS is defined as the time from the date of randomisation until death due to any cause.
Time Frame
From date of randomization up to approximately 10 years
Title
PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population
Description
Ratio of metabolite-to-osimertinib to be calculated at predose, and at 0.5-2 hours postdose.
Time Frame
From date of randomisation up to approximately 10 years
Title
Impact of osimertinib versus placebo on physical functioning
Description
Assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and the overall population as measured by SF-36 V2 health survey
Time Frame
From date of randomisation up to approximately 10 years
Title
Central Nervous System (CNS) Disease-Free Survival (DFS) in both the high-risk stratum and the overall population
Description
CNS DFS is defined as the time from randomisation to the time of a CNS lesion (as assessed by investigator) or death due to any cause, regardless of whether the participant withdraws from study intervention or receives other anti-cancer therapy.
Time Frame
From date of randomisation up to approximately 10 years
Title
Safety and tolerability in overall population
Description
AEs graded by CTCAE version 5.0
Time Frame
From date of randomisation up to approximately 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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, 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.
Exclusion Criteria
Mixed small cell and non-small cell cancer history.
Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy, bilobectomy or only wedge resection.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and HIV.
History of another primary malignancy 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 QTc 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 QTc 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Goldman, MD
Organizational Affiliation
UCLA Department of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasuhiro Tsutani, MD, PhD
Organizational Affiliation
Kindai University Facility of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie He, MD, PhD
Organizational Affiliation
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1012AAR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cipolletti
ZIP/Postal Code
8234
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000CVB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
S.C. De Bariloche
ZIP/Postal Code
8400
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30380-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Blumenau
ZIP/Postal Code
89030-101
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ibirapuera
ZIP/Postal Code
04501-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Recife
ZIP/Postal Code
52010-075
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22271-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100210
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
102218
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
430033
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510100
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guiyang
ZIP/Postal Code
550002
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150049
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
2501117
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Luoyang
ZIP/Postal Code
471003
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518116
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xintai
ZIP/Postal Code
54031
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Georgsmarienhuette
ZIP/Postal Code
49124
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97067
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Catania
ZIP/Postal Code
95100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-0877
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
227-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wakayama-shi
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinju-si
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03082
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pulau Pinang
ZIP/Postal Code
10450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Selangor
ZIP/Postal Code
46050
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bystra
ZIP/Postal Code
43-360
Country
Poland
Individual Site Status
Suspended
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Suspended
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-419
Country
Poland
Individual Site Status
Suspended
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Floresti
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Galati
ZIP/Postal Code
6200
Country
Romania
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ovidiu
ZIP/Postal Code
905900
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191036
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kadıkoy/Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wythenshawe
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh city
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
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