Trial Title:
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
NCT ID:
NCT05687266
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Durvalumab
Conditions: Keywords:
Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Datopotamab deruxtecan (Dato-DXd)
Durvalumab
Carboplatin
Chemotherapy
Antibody-Drug Conjugate (ADC)
Trophoblast cell surface protein 2 (TROP2)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Datopotamab deruxtecan
Description:
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Arm group label:
Dato-DXd + Durvalumab + Carboplatin
Other name:
Dato-DXd
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Arm group label:
Dato-DXd + Durvalumab + Carboplatin
Other name:
MEDI4736, Imfinzi
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Arm group label:
Dato-DXd + Durvalumab + Carboplatin
Arm group label:
Histologic-specific therapy
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum
of 35 cycles or 2 years (whichever occurs first).
Arm group label:
Histologic-specific therapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Arm group label:
Histologic-specific therapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Arm group label:
Histologic-specific therapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Arm group label:
Histologic-specific therapy
Summary:
This is a Phase III, randomized, open-label, multicenter, global study to compare the
efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab
and carboplatin compared with pembrolizumab in combination with histology-specific
platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or
IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations,
and ALK and ROS1 rearrangements).
Detailed description:
Participants with locally advanced or metastatic NSCLC without actionable tumor tissue
genomic alterations and confirmed to meet all eligibility criteria will be randomized in
a 1:1 ratio to Dato-DXd in combination with durvalumab and carboplatin versus
pembrolizumab in combination with histology-specific platinum-based chemotherapy as
first-line treatment.
The primary objectives of the study are to demonstrate superiority of Dato-DXd in
combination with durvalumab and carboplatin relative to pembrolizumab in combination with
platinum-based chemotherapy by assessment of Progression Free Survival (PFS) by BICR and
Overall Survival (OS) in first-line treatment of TROP2 biomarker positive participants.
Criteria for eligibility:
Criteria:
Inclusion:
- Participants ≥ 18 years at screening
- Histologically or cytologically documented NSCLC that at the time of randomisation
is Stage IIIB or IIIC disease not amenable to surgical resection or definitive
chemoradiation or Stage IV metastatic disease
- Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and
has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other
actionable driver oncogenes with approved and available therapies (actionable
genomic alterations).
Testing is not required for tumors with squamous histology, with exceptions.
- ECOG PS of 0 or 1
- Archival tumour tissue
- Has adequate bone marrow reserve and organ function within 7 days before
randomization
Exclusion:
- Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
- History of another primary malignancy with exceptions
- Persistent toxicities caused by previous anti-cancer therapy not yet improved to
Grade ≤ 1 or baseline, with exceptions.
- Spinal cord compression or clinically or radiologically active brain metastases
- History of leptomeningeal carcinomatosis.
- Known active or uncontrolled hepatitis B or C virus infection.
- Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or
antifungals.
- Clinically significant corneal disease
- History of non-infectious ILD/pneumonitis that required steroids, has current
ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by
imaging at screening.
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tucson
Zip:
85704
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hot Springs National Park
Zip:
71913
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lakewood
Zip:
90805
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Boulder
Zip:
80303
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Lauderdale
Zip:
33308
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lakeland
Zip:
33812
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Evergreen Park
Zip:
60805
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Quincy
Zip:
62301
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Wayne
Zip:
46845
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Muncie
Zip:
47303
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bettendorf
Zip:
52722
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Covington
Zip:
70433
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Duluth
Zip:
55805
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hannibal
Zip:
63401
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lincoln
Zip:
68506
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lincoln
Zip:
68516
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Clifton Park
Zip:
12065
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
East Hills
Zip:
11548
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
East Syracuse
Zip:
13057
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
West Islip
Zip:
11795
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Asheville
Zip:
28806
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Goldsboro
Zip:
27534
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Winston-Salem
Zip:
27103
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fargo
Zip:
58102
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Canton
Zip:
44710
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Columbus
Zip:
43219
Country:
United States
Status:
Completed
Facility:
Name:
Research Site
Address:
City:
Toledo
Zip:
43623
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tulsa
Zip:
74134
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Salem
Zip:
97301
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
York
Zip:
17403
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Watertown
Zip:
57201
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Knoxville
Zip:
37916
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Denton
Zip:
76201
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Irving
Zip:
75063
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
San Antonio
Zip:
78240
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sugar Land
Zip:
77479
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Belvoir
Zip:
22060
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Henrico
Zip:
23229
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Auburn
Zip:
98001
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Renton
Zip:
98055
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Appleton
Zip:
54911
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Graz
Zip:
8036
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rankweil
Zip:
6830
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wien
Zip:
1210
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Blumenau
Zip:
89010-340
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fortaleza
Zip:
60336-045
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Londrina
Zip:
86015-520
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
01327-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
01509-900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
09323-900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taubaté
Zip:
12030-200
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vitoria
Zip:
29043-260
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Panagyurishte
Zip:
4500
Country:
Bulgaria
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Plovdiv
Zip:
4004
Country:
Bulgaria
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Plovdiv
Zip:
4109
Country:
Bulgaria
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Sofia
Zip:
1113
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sofia
Zip:
1330
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sofia
Zip:
1407
Country:
Bulgaria
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Sofia
Zip:
1618
Country:
Bulgaria
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Varna
Zip:
9010
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint John
Zip:
E2L 4L2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brampton
Zip:
L6R 3J7
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kitchener
Zip:
N2G 1G3
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Newmarket
Zip:
L3Y 2P9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sudbury
Zip:
P3E 5J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H1T 2M4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4J 1C5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
St-Jerome
Zip:
J7Z 5T3
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saskatoon
Zip:
S7N 4H4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100029
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100037
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100039
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100039
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
CN-100730
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Completed
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610072
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Chongqing
Zip:
400037
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510100
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230601
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Jinan
Zip:
250021
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kunming
Zip:
650032
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kunming
Zip:
650101
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Liuzhou
Zip:
545006
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shandong
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200080
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shantou
Zip:
515041
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shenzhen
Zip:
517108
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shijiazhuang
Zip:
050020
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430060
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Xiamen
Zip:
361004
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Yangzhou
Zip:
225001
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Herning
Zip:
7400
Country:
Denmark
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Næstved
Zip:
4700
Country:
Denmark
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Sønderborg
Zip:
6400
Country:
Denmark
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Brest
Zip:
29200
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Creteil
Zip:
94010
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gleize
Zip:
69400
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montpellier
Zip:
34070
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nimes
Zip:
30029
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Paris CEDEX 14
Zip:
75674
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Paris
Zip:
75018
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint-Quentin cedex
Zip:
02321
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Strasbourg Cedex
Zip:
67091
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Toulon Cedex 9
Zip:
83800
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tours
Zip:
37000
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bad Berka
Zip:
99437
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
12351
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
14109
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Frankfurt A. Main
Zip:
60590
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gütersloh
Zip:
33332
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamburg
Zip:
20251
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kassel
Zip:
34125
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kiel
Zip:
24116
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Koblenz
Zip:
56073
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Minden
Zip:
32429
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mönchengladbach
Zip:
41063
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Paderborn
Zip:
33098
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Rosenheim
Zip:
83022
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Velbert
Zip:
42551
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Würzburg
Zip:
97074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Athens
Zip:
11526
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Athens
Zip:
11527
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Athens
Zip:
155 62
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Peiraias
Zip:
185 47
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Thessaloniki
Zip:
55236
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Thessaloniki
Zip:
57001
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Budapest
Zip:
1121
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Budapest
Zip:
1122
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gyöngyös - Mátraháza
Zip:
3200
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaposvár
Zip:
7400
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pécs
Zip:
7624
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Szekszárd
Zip:
7100
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Szolnok
Zip:
5000
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Törökbálint
Zip:
2045
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Calicut
Zip:
673601
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Delhi
Zip:
110029
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Delhi
Zip:
110085
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Jaipur
Zip:
302017
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kolkata
Zip:
700160
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madurai
Zip:
625107
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New Delhi
Zip:
110063
Country:
India
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Puducherry
Zip:
605006
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lecco
Zip:
23900
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Messina
Zip:
98158
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Peschiera Del Garda
Zip:
37019
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bunkyo-ku
Zip:
113-8603
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamamatsu-shi
Zip:
431-3192
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamamatsu-shi
Zip:
432-8580
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hidaka-shi
Zip:
350-1298
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Himeji-shi
Zip:
670-8520
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hirosaki-shi
Zip:
036-8563
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima-shi
Zip:
730-8518
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kumamoto-shi
Zip:
860-8556
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Morioka-shi
Zip:
028-3695
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
466-8560
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Natori-shi
Zip:
981-1293
Country:
Japan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Okayama-shi
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka-shi
Zip:
545-8586
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Osakasayama-shi
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sapporo-shi
Zip:
060-8638
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
221-0855
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Jinju-si
Zip:
52727
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05368
Country:
Korea, Republic of
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
07061
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Suwon-si
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cdmx
Zip:
03810
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Del. Cuauhtemoc
Zip:
06700
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Merida
Zip:
97000
Country:
Mexico
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Mexico
Zip:
14080
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mexico
Zip:
3100
Country:
Mexico
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
San Luis Potosí
Zip:
78209
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Arequipa
Zip:
04002
Country:
Peru
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Concepción
Zip:
12125
Country:
Peru
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lima
Zip:
15036
Country:
Peru
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lima
Zip:
34
Country:
Peru
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lima
Zip:
LIMA 27
Country:
Peru
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lima
Zip:
LIMA 29
Country:
Peru
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bystra
Zip:
43-360
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Grudziądz
Zip:
86-300
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kielce
Zip:
25-734
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Olsztyn
Zip:
10-357
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Piła
Zip:
64-920
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Poznań
Zip:
60-569
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Przemysl
Zip:
37-700
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Racibórz
Zip:
47-400
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Radom
Zip:
26-600
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Siedlce
Zip:
08-110
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tomaszów Mazowiecki
Zip:
97-200
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wroclaw
Zip:
53-413
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Girona
Zip:
17007
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Las Palmas de Gran Canaria
Zip:
35016
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lugo
Zip:
27003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gävle
Zip:
801 88
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Linköping
Zip:
581 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lund
Zip:
221 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Uppsala
Zip:
751 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hsinchu
Zip:
300
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
73657
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei City
Zip:
110
Country:
Taiwan
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Taipei City
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
235
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Adana
Zip:
01060
Country:
Turkey
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Istanbul
Zip:
34098
Country:
Turkey
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Izmir
Zip:
35110
Country:
Turkey
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Aberdeen
Zip:
AB25 2ZN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cardiff
Zip:
CF14 2TL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cheltenham
Zip:
GL53 7AN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
W6 8RF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Middlesborough
Zip:
TS4 3BW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Newcastle-Upon-Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taunton
Zip:
TA1 5DA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Torquay
Zip:
TQ2 7AA
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hanoi
Zip:
100000
Country:
Vietnam
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Ho Chi Minh city
Zip:
700000
Country:
Vietnam
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Ho Chi Minh
Zip:
700000
Country:
Vietnam
Status:
Active, not recruiting
Start date:
December 29, 2022
Completion date:
February 22, 2027
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687266