Back to resultsA 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)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Osimertinib
Cisplatin
Carboplatin
Placebo
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Resectable; NSCLC; Osimertinib; EGFRm Positive; Neoadjuvant; Adjuvant
Eligibility Criteria
Inclusion Criteria:
- 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 (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
Exclusion Criteria:
- 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, 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
- 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 aorta, the oesophagus and/or the heart; 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)
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Arm 1: Placebo with platinum-based chemotherapy
Arm 2: Osimertinib with platinum-based chemotherapy
Arm 3: Osimertinib monotherapy
Arm Description
Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
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 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)
Outcomes
Primary Outcome Measures
Major Pathological Response (MPR)
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery
Secondary Outcome Measures
Pathological complete response (pCR)
Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery
Event-free survival (EFS)
An event is defined as documented disease progression that precludes surgery or requires non-protocol therapy; recurrence or a new lesion, local or distant (a new primary malignancy confirmed by pathology is not considered to be an EFS event.); death due to any cause
Overall Survival (OS)
Patients will be followed up to approximately 5.5 years after the last patient is randomized
Disease free survival (DFS)
DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.
Downstaging
Measured using pathologic mediastinal lymph node evaluation
Difference between treatment arms in change from baseline in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items)
Assess disease-related symptoms, functioning, and global health status/quality-of-life in patients
Concordance of EGFRm status between tumour tissue DNA and patient-matched plasma-derived ctDNA
Corcordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples
PK plasma concentrations of osimertinib
Difference between treatment arms in change from baseline in EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items)
Assess lung cancer-associated symptoms and side effects from conventional chemotherapy and radiotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04351555
Brief Title
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
Acronym
NeoADAURA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
June 27, 2024 (Anticipated)
Study Completion Date
July 2, 2029 (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 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
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
Resectable; NSCLC; Osimertinib; EGFRm Positive; Neoadjuvant; Adjuvant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Placebo with platinum-based chemotherapy
Arm Type
Placebo Comparator
Arm Description
Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
Arm Title
Arm 2: Osimertinib with platinum-based chemotherapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Arm 3: Osimertinib monotherapy
Arm Type
Experimental
Arm Description
Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)
Intervention Type
Drug
Intervention Name(s)
Osimertinib
Other Intervention Name(s)
AZD9291; TAGRISSO
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Primary Outcome Measure Information:
Title
Major Pathological Response (MPR)
Description
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery
Time Frame
From date of randomization to an average of 12 weeks after the first dose
Secondary Outcome Measure Information:
Title
Pathological complete response (pCR)
Description
Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery
Time Frame
From date of randomization to an average of 12 weeks after the first dose
Title
Event-free survival (EFS)
Description
An event is defined as documented disease progression that precludes surgery or requires non-protocol therapy; recurrence or a new lesion, local or distant (a new primary malignancy confirmed by pathology is not considered to be an EFS event.); death due to any cause
Time Frame
Up to approximately 42 months after the last patient is randomized
Title
Overall Survival (OS)
Description
Patients will be followed up to approximately 5.5 years after the last patient is randomized
Time Frame
Up to approximately 5.5 years after the last patient is randomized
Title
Disease free survival (DFS)
Description
DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.
Time Frame
From date of randomization up to approximately 42 months after date of resection
Title
Downstaging
Description
Measured using pathologic mediastinal lymph node evaluation
Time Frame
From date of randomization to an average of 12 weeks after the first dose
Title
Difference between treatment arms in change from baseline in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items)
Description
Assess disease-related symptoms, functioning, and global health status/quality-of-life in patients
Time Frame
From first randomization to 42 months after the last patient is randomized
Title
Concordance of EGFRm status between tumour tissue DNA and patient-matched plasma-derived ctDNA
Time Frame
Baseline
Title
Corcordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples
Time Frame
Baseline
Title
PK plasma concentrations of osimertinib
Time Frame
From the pre-dose of Cycle 2 to post-dose of Cycle 3 (each cycle is 21 days)
Title
Difference between treatment arms in change from baseline in EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items)
Description
Assess lung cancer-associated symptoms and side effects from conventional chemotherapy and radiotherapy
Time Frame
From first randomization to 42 months after the last patient is randomized
Other Pre-specified Outcome Measures:
Title
Cure rate
Description
The cure rate is defined as the percentage of people in this study who are still alive and disease free for a certain period of time after they finished the surgery. Here 5-year landmark cure rate will be calculated in the same time as OS analysis.
Time Frame
From the surgery until 5 years after surgery
Title
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
Description
Other clinical variables include deaths, laboratory data, vital signs (pulse and BP), ECG, LVEF, ECOG performance status, and ophthalmologic assessment
Time Frame
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
Title
MPR using plasma-derived circulating-free tumour DNA (ctDNA)
Time Frame
From first randomization to 42 months after the last patient is randomized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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)
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
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Cancer Study Locator
Phone
1-877-400-4656
Email
astrazeneca@emergingmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Chaft, MD
Organizational Affiliation
Memorial Sloan Kettering, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Masahiro Tsuboi, MD
Organizational Affiliation
National Cancer Center Hospital East, Japan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Weder, MD
Organizational Affiliation
Thoraxchirurgie Bethanien, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Withdrawn
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
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Vienna
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1210
Country
Austria
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
30110-022
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bento Goncalves
ZIP/Postal Code
95700-084
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60135-040
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ibirapuera
ZIP/Postal Code
04501-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jau
ZIP/Postal Code
17204310
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-000
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
Ribeirão Preto
ZIP/Postal Code
14021-636
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22271-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Maria
ZIP/Postal Code
97015-450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04038-034
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
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
Concepcion
ZIP/Postal Code
4070196
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
La Serena
ZIP/Postal Code
1720430
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Las Condes
ZIP/Postal Code
7560908
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Providencia
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500713
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7520349
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8380455
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Viña del Mar
ZIP/Postal Code
2540488
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Withdrawn
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
CN-100730
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510062
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510095
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
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
310006
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310009
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
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Linhai
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nantong
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shandong
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
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518053
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
Urumqi
ZIP/Postal Code
830000
Country
China
Individual Site Status
Terminated
Facility Name
Research Site
City
Wanzhou
ZIP/Postal Code
404000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
CN-325000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361004
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
Withdrawn
Facility Name
Research Site
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Avignon Cedex
ZIP/Postal Code
84902
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toulon Cedex 9
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Esslingen a.N.
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gauting
ZIP/Postal Code
82131
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
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Köln
ZIP/Postal Code
51109
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
Delhi
ZIP/Postal Code
110085
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700160
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Manipal
ZIP/Postal Code
576104
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400036
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Namakkal
ZIP/Postal Code
637001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Varanasi
ZIP/Postal Code
221005
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kfar Saba
ZIP/Postal Code
95847
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
62748
Country
Israel
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
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orbassano
ZIP/Postal Code
10043
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
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Akashi-shi
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-8677
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
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
Sakai-shi
ZIP/Postal Code
591-8555
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
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hwasun-gun
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yangsan-si
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
D.F
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
'14080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
La Libertad
ZIP/Postal Code
13013
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
0051
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15038
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L41
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-540
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Withdrawn
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
71-455
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
53-439PL
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nizhniy Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
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
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland
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
40447
Country
Taiwan
Individual Site Status
Terminated
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
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
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
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
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pathumwan
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Phisanulok
ZIP/Postal Code
65000
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
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Malatya
ZIP/Postal Code
44280
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
Liverpool
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Manchester
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
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
70000
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 rerefer to our disclosure commitment at 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
Citations:
PubMed Identifier
34278827
Citation
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.
Results Reference
derived
Learn more about this trial
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
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