Back to resultsA Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Placebo
Carboplatin/Paclitaxel
Cisplatin/Gemcitabine
Pemetrexed/Cisplatin
Pemetrexed/Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
- World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
- No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
- Adequate organ and marrow function
- Confirmation of a patient's tumour PD-L1 status
- Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
- Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy
Exclusion Criteria:
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
- History of another primary malignancy
- History of active primary immunodeficiency
- Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
- Deemed unresectable NSCLC by multidisciplinary evaluation
- Patients who have pre-operative radiotherapy treatment as part of their care plan
- Patients who have brain metastases or spinal cord compression
- Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
- Known allergy or hypersensitivity to any of the study drugs or excipients
- Existence of more than one primary tumour such as mixed small cell and NSCLC histology
- Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
- Patients with a documented test result confirming the presence of EGFRm or ALK translocation
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1: Durvalumab + platinum-based chemotherapy
Arm 2: Placebo + platinum-based chemotherapy
Arm Description
Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel cisplatin/gemcitabine pemetrexed/cisplatin pemetrexed/carboplatin
Placebo in concurrence with platinum-based chemotherapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel cisplatin/gemcitabine pemetrexed/cisplatin pemetrexed/carboplatin
Outcomes
Primary Outcome Measures
Pathological Complete Response (pCR) in modified intent-to-treat (mITT)
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
Event-Free Survival (EFS)
An event defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
Secondary Outcome Measures
Disease-free survival (DFS) in modified resected population
Major Pathological Response (mPR)
Overall Survival (OS)
Event-free survival (EFS) in PD-L1-TC ≥1% positive patients
pCR in PD-L1-TC ≥1% positive patients
Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients
Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients
Overall Survival (OS) in PD-L1-TC ≥1% positive patients
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
To assess the PK of durvalumab in blood (through concentration)
To assess concentration of durvalumab in bloodstream.
Presence of ADA for durvalumab
To evaluate the presence of antibodies following treatment with study medications.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03800134
Brief Title
A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
Acronym
AEGEAN
Official Title
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
September 11, 2028 (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, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.
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 Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
826 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Durvalumab + platinum-based chemotherapy
Arm Type
Experimental
Arm Description
Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:
carboplatin/paclitaxel
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin
Arm Title
Arm 2: Placebo + platinum-based chemotherapy
Arm Type
Placebo Comparator
Arm Description
Placebo in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:
carboplatin/paclitaxel
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab IV (intravenous infusion)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo IV (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
Carboplatin/Paclitaxel
Intervention Description
Carboplatin/Paclitaxel, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Cisplatin/Gemcitabine
Intervention Description
Cisplatin/Gemcitabine, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/Cisplatin
Intervention Description
Pemetrexed/Cisplatin, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/Carboplatin
Intervention Description
Pemetrexed/Carboplatin, as per standard of care
Primary Outcome Measure Information:
Title
Pathological Complete Response (pCR) in modified intent-to-treat (mITT)
Description
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
Time Frame
From screening pathology to an average of 15 weeks after first dose.
Title
Event-Free Survival (EFS)
Description
An event defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
Time Frame
Up to 5.5 years after first patient randomized.
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS) in modified resected population
Time Frame
From date of randomization to 5.5 years after date of resection
Title
Major Pathological Response (mPR)
Time Frame
From screening pathology to an average of 15 weeks after first dose.
Title
Overall Survival (OS)
Time Frame
From date of randomization to 5.5 years after randomization
Title
Event-free survival (EFS) in PD-L1-TC ≥1% positive patients
Time Frame
From date of randomization to 5.5 years after randomization
Title
pCR in PD-L1-TC ≥1% positive patients
Time Frame
From screening pathology to an average of 15 weeks after first dose
Title
Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients
Time Frame
From date of randomization to 5.5 years after date of resection
Title
Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients
Time Frame
From screening pathology to an average of 15 weeks after first dose.
Title
Overall Survival (OS) in PD-L1-TC ≥1% positive patients
Time Frame
From date of randomization to 5.5 years after randomization.
Title
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
Description
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Time Frame
From date of screening to 6 months after last dose of IP
Title
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
Description
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Time Frame
From date of screening to 6 months after last dose of IP
Title
To assess the PK of durvalumab in blood (through concentration)
Description
To assess concentration of durvalumab in bloodstream.
Time Frame
From date of randomization to 2 months after resection
Title
Presence of ADA for durvalumab
Description
To evaluate the presence of antibodies following treatment with study medications.
Time Frame
From date of randomization to 3 months after last dose of IP
Other Pre-specified Outcome Measures:
Title
Number of participants with all adverse events as assessed by CTCAE v5.0
Time Frame
64 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
Adequate organ and marrow function
Confirmation of a patient's tumour PD-L1 status
Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy
Exclusion Criteria:
History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
History of another primary malignancy
History of active primary immunodeficiency
Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
Deemed unresectable NSCLC by multidisciplinary evaluation
Patients who have pre-operative radiotherapy treatment as part of their care plan
Patients who have brain metastases or spinal cord compression
Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
Known allergy or hypersensitivity to any of the study drugs or excipients
Existence of more than one primary tumour such as mixed small cell and NSCLC histology
Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
Patients with a documented test result confirming the presence of EGFRm or ALK translocation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Heymach, MD
Organizational Affiliation
UT MD Anderson Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Research Site
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Research Site
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Research Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Research Site
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Research Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Research Site
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research Site
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29424
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Research Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Research Site
City
Pergamino
ZIP/Postal Code
B2700CPM
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000DEJ
Country
Argentina
Facility Name
Research Site
City
San Salvador de Jujuy
ZIP/Postal Code
4600
Country
Argentina
Facility Name
Research Site
City
Viedma
ZIP/Postal Code
R8500ACE
Country
Argentina
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30380-090
Country
Brazil
Facility Name
Research Site
City
Campinas
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Research Site
City
Florianópolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Research Site
City
Natal
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Santa Maria
ZIP/Postal Code
97015-450
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Research Site
City
Teresina
ZIP/Postal Code
64049-200
Country
Brazil
Facility Name
Research Site
City
Vitoria
ZIP/Postal Code
29043-260
Country
Brazil
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Research Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Research Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500713
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Research Site
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Research Site
City
Viña del Mar
ZIP/Postal Code
2540488
Country
Chile
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Research Site
City
Changzhou
ZIP/Postal Code
213000
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510095
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Research Site
City
Guiyang
ZIP/Postal Code
550002
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310052
Country
China
Facility Name
Research Site
City
Hangzhou
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650118
Country
China
Facility Name
Research Site
City
Linhai
ZIP/Postal Code
317000
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Research Site
City
Ningbo
ZIP/Postal Code
315000
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110042
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110044
Country
China
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518035
Country
China
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Research Site
City
Urumqi
ZIP/Postal Code
830000
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361004
Country
China
Facility Name
Research Site
City
Xintai
ZIP/Postal Code
54031
Country
China
Facility Name
Research Site
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Research Site
City
San José
ZIP/Postal Code
1000
Country
Costa Rica
Facility Name
Research Site
City
San José
Country
Costa Rica
Facility Name
Research Site
City
Avignon Cedex
ZIP/Postal Code
84902
Country
France
Facility Name
Research Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06100
Country
France
Facility Name
Research Site
City
Toulon Cedex 9
ZIP/Postal Code
83800
Country
France
Facility Name
Research Site
City
Vantoux
ZIP/Postal Code
57070
Country
France
Facility Name
Research Site
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Research Site
City
Immenstadt
ZIP/Postal Code
87509
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Research Site
City
Gyöngyös - Mátraháza
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Research Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Research Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Research Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
380060
Country
India
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122002
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700160
Country
India
Facility Name
Research Site
City
Manipal
ZIP/Postal Code
576104
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400053
Country
India
Facility Name
Research Site
City
Mysuru
ZIP/Postal Code
570017
Country
India
Facility Name
Research Site
City
Namakkal
ZIP/Postal Code
637001
Country
India
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422002
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Research Site
City
Thane
ZIP/Postal Code
401107
Country
India
Facility Name
Research Site
City
Vishakhapatnam
ZIP/Postal Code
530017
Country
India
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00100
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Research Site
City
Habikino-shi
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Research Site
City
Himeji-shi
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Research Site
City
Iwakuni-shi
ZIP/Postal Code
740-8510
Country
Japan
Facility Name
Research Site
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Research Site
City
Kitakyushu-shi
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Research Site
City
Kurashiki shi
ZIP/Postal Code
701 0192
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Research Site
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Research Site
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Research Site
City
Wakayama-shi
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Research Site
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
362-804
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44680
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Research Site
City
México
ZIP/Postal Code
1400
Country
Mexico
Facility Name
Research Site
City
México
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Research Site
City
Pachuca de Soto
ZIP/Postal Code
42090
Country
Mexico
Facility Name
Research Site
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Research Site
City
Bellavista
ZIP/Postal Code
CALLAO 2
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Research Site
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Research Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Research Site
City
Makati
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115008
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Rostov-on-Don
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Research Site
City
Santiago De Compostela (A Coruña)
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Research Site
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Lampang
ZIP/Postal Code
52000
Country
Thailand
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
10000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
70000
Country
Vietnam
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 at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified 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 Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
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