Trial Title:
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT06417814
Condition:
Metastatic Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Osimertinib
Conditions: Keywords:
Epidermal growth factor receptor gene mutation
Standard of Care
Locally, advanced carcinoma
Metastatic carcinoma
Non-small cell lung cancer
Dato-dxd
Datopotamab deruxtecan
Osimertinib
Tagrisso
Pemetrexed
Carboplatin
Cisplatin
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)
Intervention:
Intervention type:
Drug
Intervention name:
Dato-DXd
Description:
Dato-DXd will be administered as IV infusion.
Arm group label:
Group 1: Dato-DXd + Osimertinib Combination Therapy
Arm group label:
Group 2: Dato-DXd Monotherapy
Other name:
DS-1062a
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Osimertinib will be administered orally.
Arm group label:
Group 1: Dato-DXd + Osimertinib Combination Therapy
Other name:
Tagrisso
Other name:
AZD9291
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed will be administered as IV infusion.
Arm group label:
Group 3: Platinum-based Doublet Chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin will be administered as IV infusion.
Arm group label:
Group 3: Platinum-based Doublet Chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin will be administered as IV infusion.
Arm group label:
Group 3: Platinum-based Doublet Chemotherapy
Summary:
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd
monotherapy versus platinum-based doublet chemotherapy in terms of progression-free
survival (PFS).
Detailed description:
This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of
Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based
doublet chemotherapy in participants with epidermal growth factor receptor gene mutation
(EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease
has progressed on prior osimertinib treatment.
Participants will be randomized in a 1:1:1 ratio to one of the following intervention
groups:
1. Dato-DXd + osimertinib combination therapy
2. Dato-DXd monotherapy
3. Platinum-based doublet chemotherapy
Participants will receive study intervention until Response Evaluation Criteria in Solid
Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator,
unacceptable toxicity, or other discontinuation criterion is met.
After study intervention discontinuation, all participants will undergo an end of
treatment (EoT) visit within 35 days of discontinuation and will be followed up for
safety assessments 28 (+ 7) days after their last dose of study intervention.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed non-squamous NSCLC.
- Must have evidence of documented pre-existing EGFRm information (EGFRm known to be
associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor
[TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in
combination with other EGFR mutations, which may include T790M).
- Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as
most recent line of treatment) in the adjuvant, locally advanced, or metastatic
setting.
- Less than or equal to (<=2) prior lines of EGFR TKIs (osimertinib is the only
permitted prior third generation EGFR TKI).
- At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL
at baseline and can be accurately measured at baseline.
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1.
- Adequate bone marrow reserve and organ function within 7 days before randomization.
Exclusion Criteria:
- Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or
any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in
non-metastatic setting within 12 months prior to randomization.
- History of another primary malignancy except for malignancy treated with curative
intent with no known active disease within 2 years before the first dose of study
intervention.
- Any evidence of severe or uncontrolled systemic diseases, including, but not limited
to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac
disease.
- Has significant third-space fluid retention (example [eg.], ascites or pleural
effusion) as judged by the investigator and is not amenable for required repeated
drainage.
- History of non-infectious ILD/pneumonitis including radiation pneumonitis that
required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected
ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Has severe pulmonary function compromise resulting from intercurrent pulmonary
illnesses.
- Unstable spinal cord compression and/or unstable brain metastases.
- Participants with symptomatic brain metastases (including leptomeningeal
involvement).
- Clinically significant corneal disease.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals,
suspected infections or inability to rule out infections.
- Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Fayetteville
Zip:
72703
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United States
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City:
Duarte
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91010
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United States
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La Jolla
Zip:
92093
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United States
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Los Angeles
Zip:
90048
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Evanston
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60201-1718
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Baltimore
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21201
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Bethesda
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20817
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Detroit
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48202
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Morristown
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07960
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New York
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10016
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Status:
Suspended
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City:
New York
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10065
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Fairfax
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22031
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Heidelberg
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3084
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Kogarah
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Liverpool
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2170
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Nedlands
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6009
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Port Macquarie
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2444
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St Leonards
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2065
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Westmead
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2145
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Charleroi
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6000
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Belgium
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Edegem
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2650
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Gent
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9000
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Ghent
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9000
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Belgium
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Hasselt
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3500
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Barretos
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14784-400
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Itajai
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88301-220
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Brazil
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Porto Alegre
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90470-340
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Brazil
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Porto Alegre
Zip:
90610-000
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Brazil
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Rio de Janeiro
Zip:
22250-905
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Brazil
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Address:
City:
Rio de Janeiro
Zip:
22281-100
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Brazil
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Address:
City:
Rio de Janeiro
Zip:
22775-001
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Brazil
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Address:
City:
Sao Paulo
Zip:
01327-001
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Brazil
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Address:
City:
São Paulo
Zip:
01323-900
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Brazil
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Address:
City:
Brampton
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L6R 3J7
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Address:
City:
Newmarket
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L3Y 2P9
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Canada
Status:
Suspended
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Address:
City:
Toronto
Zip:
M4N 3M5
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Canada
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Address:
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Toronto
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M5G 1Z5
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Canada
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Montreal
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H4A 3J1
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Quebec
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Address:
City:
Baoding
Zip:
071000
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China
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Address:
City:
Beijing
Zip:
100005
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China
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Research Site
Address:
City:
Beijing
Zip:
100034
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China
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Research Site
Address:
City:
Beijing
Zip:
100044
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China
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Research Site
Address:
City:
Beijing
Zip:
100142
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China
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Address:
City:
Beijing
Zip:
100730
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China
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Address:
City:
Changchun
Zip:
130012
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China
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Address:
City:
Changchun
Zip:
130021
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China
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Address:
City:
Changsha
Zip:
410013
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China
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Chengdu
Zip:
610041
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China
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Address:
City:
Deyang
Zip:
618000
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China
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City:
Ganzhou
Zip:
341099
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China
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Guangdong
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China
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City:
Guangzhou
Zip:
510100
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China
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Address:
City:
Hangzhou
Zip:
310022
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China
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Address:
City:
Hefei
Zip:
230000
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China
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Address:
City:
Huaian
Zip:
223399
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China
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Address:
City:
Jinan
Zip:
250013
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China
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Name:
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Address:
City:
Linyi
Zip:
276000
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China
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Address:
City:
Luoyang
Zip:
471003
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China
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Address:
City:
Nanchang
Zip:
330006
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China
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Address:
City:
Nanjing
Zip:
210009
Country:
China
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Name:
Research Site
Address:
City:
Tianjin
Zip:
CN-300052
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China
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Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450000
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China
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Address:
City:
Zhengzhou
Zip:
450001
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China
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Address:
City:
Avignon
Zip:
84902
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France
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Address:
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Bordeaux
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33076
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France
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Montpellier
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34298
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France
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Address:
City:
Quimper
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29000
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France
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Address:
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Toulon Armees
Zip:
83800
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France
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Address:
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Toulouse Cedex 9
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31400
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France
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Villejuif Cedex
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94805
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France
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Essen
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45122
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Germany
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Georgsmarienhuette
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49124
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Germany
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Großhansdorf
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22927
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Germany
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Hamburg
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20251
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Germany
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Hamburg
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21075
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Germany
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Heidelberg
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69126
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Germany
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Kempten
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87439
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Germany
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Nürnberg
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90419
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Germany
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Oldenburg
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26121
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Germany
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Athens
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11527
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Greece
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Thessaloniki
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552 36
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Greece
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Thessaloniki
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57001
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Amravati
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444606
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India
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Bhubaneswar
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751019
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India
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Hyderabad
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500034
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Kolhapur
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416234
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India
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637001
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India
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Pune
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411001
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India
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Thane
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401107
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India
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Trivandrum
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695011
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India
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221005
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Israel
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91031
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Israel
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Bari
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70124
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Italy
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Milano
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20141
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Italy
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95045
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Italy
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Monza
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20090
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Italy
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Napoli
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80131
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Italy
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Padova
Zip:
35128
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Italy
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Parma
Zip:
43126
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Italy
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Roma
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00144
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Italy
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Rozzano
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20089
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Italy
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Fukuoka-shi
Zip:
812-8582
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Japan
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Address:
City:
Iwakuni-shi
Zip:
740-8510
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Japan
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Address:
City:
Kobe
Zip:
650-0046
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Japan
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Address:
City:
Koto-ku
Zip:
135-8550
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Japan
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Address:
City:
Kumamoto-shi
Zip:
860-8556
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Japan
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Address:
City:
Kyoto-shi
Zip:
602-8566
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Japan
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Address:
City:
Nagoya-shi
Zip:
464-8681
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Japan
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Address:
City:
Nagoya-shi
Zip:
466-8560
Country:
Japan
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Name:
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Address:
City:
Niigata-shi
Zip:
951-8566
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Japan
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Address:
City:
Osaka-Sayama
Zip:
589-8511
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Japan
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Address:
City:
Osaka-shi
Zip:
534-0021
Country:
Japan
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Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
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Name:
Research Site
Address:
City:
Sendai-shi
Zip:
981-0914
Country:
Japan
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Not yet recruiting
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Research Site
Address:
City:
Toyoake-shi
Zip:
470-1192
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Japan
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Research Site
Address:
City:
Utsunomiya-shi
Zip:
320-0834
Country:
Japan
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Not yet recruiting
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Name:
Research Site
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
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Not yet recruiting
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Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
236-0051
Country:
Japan
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Not yet recruiting
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Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
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Not yet recruiting
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Name:
Research Site
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Not yet recruiting
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Name:
Research Site
Address:
City:
Chungcheongbuk-do
Zip:
28644
Country:
Korea, Republic of
Status:
Not yet recruiting
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Name:
Research Site
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Not yet recruiting
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Name:
Research Site
Address:
City:
Gyeonggi-do
Zip:
13620
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jinju-si
Zip:
52727
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Alor Setar
Zip:
05460
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Johor Bahru
Zip:
81100
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Petaling Jaya
Zip:
47500
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Selangor
Zip:
46050
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bacolod
Zip:
6100
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Cebu City
Zip:
6000
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Davao City
Zip:
8000
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Quezon
Zip:
1102
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
San Juan
Zip:
1500
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Krakow
Zip:
30-727
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Olsztyn
Zip:
10-357
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Poznan
Zip:
60-569
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Łódź
Zip:
90-302
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
308433
Country:
Singapore
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
La Coruna
Zip:
15006
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santiago De Compostela-Coruña
Zip:
15706
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41014
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Changhua City
Zip:
50006
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
New Taipei
Zip:
23561
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
73657
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei City
Zip:
110
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chiang Mai
Zip:
50200
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hat Yai
Zip:
90110
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Khon-Kaen
Zip:
40002
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pathumthani
Zip:
12120
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Birmingham
Zip:
B9 5SS
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Middlesbrough
Zip:
TS4 3BW
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hanoi
Zip:
100000
Country:
Vietnam
Status:
Not yet recruiting
Start date:
October 4, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo
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/NCT06417814
