A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

Trial Title: A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

NCT ID: NCT06627647

Condition: Non-squamous Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pembrolizumab
Pemetrexed

Conditions: Keywords:
ARTEMIDE-Lung03
Rilvegostomig (AZD2936)
Non-squamous non-small cell lung cancer (NSCLC)
Bi-specific antibody
T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)
EGFR, ALK and ROS1 testing
Programmed cell death protein (PD-L1)
Pembrolizumab
Carboplatin
Cisplatin
Pemetrexed

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Arm A: Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance. Arm B: Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: Double-blind masking

Intervention:

Intervention type: Drug
Intervention name: Rilvegostomig
Description: Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Arm group label: Arm A

Other name: AZD2936

Intervention type: Drug
Intervention name: Pembrolizumab
Description: Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Arm group label: Arm B

Other name: Keytruda

Intervention type: Drug
Intervention name: Carboplatin
Description: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Arm group label: Arm A
Arm group label: Arm B

Intervention type: Drug
Intervention name: Cisplatin
Description: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Arm group label: Arm A
Arm group label: Arm B

Intervention type: Drug
Intervention name: Pemetrexed
Description: Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Arm group label: Arm A
Arm group label: Arm B

Summary: The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Detailed description: This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically or cytologically documented non-squamous NSCLC. - Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. - Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements. - Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies. - Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%. - At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements. - Adequate organ and bone marrow function Exclusion Criteria: - Presence of small cell and neuroendocrine histology components. - Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure). - Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred > 12 months after the end of treatment. - Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. - Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. - History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. - Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. - Active primary immunodeficiency/active infectious disease(s). - Active tuberculosis infection.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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Name: Research Site

Address:
City: Phoenix
Zip: 85054
Country: United States

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Zip: 91204
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Zip: 94121
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Zip: 95403
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City: Newark
Zip: 19713
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Zip: 60637
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Zip: 21202
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Zip: 49503
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Zip: 77090
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Zip: 22031
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City: Tacoma
Zip: 98405
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Zip: C1431FWO
Country: Argentina

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City: Brussels
Zip: 1160
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City: Sint-Niklaas
Zip: 9100
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City: Ijuí
Zip: 98700-000
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City: Londrina
Zip: 86015-520
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City: Passo Fundo
Zip: 99010-260
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City: Porto Alegre
Zip: 91350-200
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City: Salvador
Zip: 40050 410
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City: Sao Paulo
Zip: 01327-001
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City: São Paulo
Zip: 01246-000
Country: Brazil

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Name: Research Site

Address:
City: São Paulo
Zip: 05652000
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Address:
City: Taubaté
Zip: 12030-200
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City: Vitoria
Zip: 29043-260
Country: Brazil

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City: Saint John
Zip: E2L 4L2
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City: Hamilton
Zip: L8V 1C3
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City: Kingston
Zip: K7L 2V7
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City: Montreal
Zip: H4A 3J1
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Name: Research Site

Address:
City: Montréal
Zip: H2X 0A9
Country: Canada

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City: Beijing
Zip: 100021
Country: China

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Address:
City: Beijing
Zip: 100029
Country: China

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Address:
City: Changsha
Zip: 410013
Country: China

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Address:
City: Chengdu
Zip: 610041
Country: China

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Address:
City: Chongqing
Zip: 400030
Country: China

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Name: Research Site

Address:
City: Fuzhou
Zip: 350007
Country: China

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Name: Research Site

Address:
City: Guangzhou
Zip: 510062
Country: China

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Name: Research Site

Address:
City: Guangzhou
Zip: 510100
Country: China

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Name: Research Site

Address:
City: Hangzhou
Zip: 310016
Country: China

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Name: Research Site

Address:
City: Hangzhou
Zip: 310022
Country: China

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Name: Research Site

Address:
City: Hefei
Zip: 230601
Country: China

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Name: Research Site

Address:
City: Jinan
Zip: 250117
Country: China

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Address:
City: Kunming
Zip: 650118
Country: China

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Address:
City: Nanchang
Zip: 330008
Country: China

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Name: Research Site

Address:
City: Shanghai
Zip: 200030
Country: China

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Name: Research Site

Address:
City: Wenzhou
Zip: CN-325000
Country: China

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Address:
City: Wuhan
Zip: 430030
Country: China

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Address:
City: Xi'an
Zip: 710061
Country: China

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Address:
City: Bad Berka
Zip: 99437
Country: Germany

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Address:
City: Berlin
Country: Germany

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Name: Research Site

Address:
City: Esslingen
Zip: 73730
Country: Germany

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City: Frankfurt
Zip: 60488
Country: Germany

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Name: Research Site

Address:
City: Gauting
Zip: 82131
Country: Germany

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Name: Research Site

Address:
City: Giessen
Zip: 35392
Country: Germany

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Name: Research Site

Address:
City: Großhansdorf
Zip: 22927
Country: Germany

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Name: Research Site

Address:
City: Hamburg
Zip: 20251
Country: Germany

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Name: Research Site

Address:
City: Hannover
Zip: 30625
Country: Germany

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Name: Research Site

Address:
City: Hemer
Zip: 58675
Country: Germany

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Name: Research Site

Address:
City: Homburg
Zip: 66424
Country: Germany

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Name: Research Site

Address:
City: Kassel
Zip: 34125
Country: Germany

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Name: Research Site

Address:
City: Kiel
Zip: 24105
Country: Germany

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Name: Research Site

Address:
City: Krefeld
Zip: 47805
Country: Germany

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Name: Research Site

Address:
City: Köln
Zip: 51109
Country: Germany

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Name: Research Site

Address:
City: Minden
Zip: 32429
Country: Germany

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Name: Research Site

Address:
City: Moers
Zip: 47441
Country: Germany

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Name: Research Site

Address:
City: München
Zip: 81925
Country: Germany

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Name: Research Site

Address:
City: Regensburg
Zip: 93053
Country: Germany

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Name: Research Site

Address:
City: Würzburg
Zip: 97067
Country: Germany

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Name: Research Site

Address:
City: Budapest
Zip: 1083
Country: Hungary

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Name: Research Site

Address:
City: Budapest
Zip: 1121
Country: Hungary

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Name: Research Site

Address:
City: Budapest
Zip: 1122
Country: Hungary

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Name: Research Site

Address:
City: Debrecen
Zip: 4032
Country: Hungary

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Name: Research Site

Address:
City: Gyöngyös
Zip: 3200
Country: Hungary

Facility:
Name: Research Site

Address:
City: Győr
Zip: 9024
Country: Hungary

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Name: Research Site

Address:
City: Pécs
Zip: 7624
Country: Hungary

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Name: Research Site

Address:
City: Székesfehérvár
Zip: 8000
Country: Hungary

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Name: Research Site

Address:
City: Törökbálint
Zip: 2045
Country: Hungary

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Name: Research Site

Address:
City: Amagasaki-shi
Zip: 660-8550
Country: Japan

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Name: Research Site

Address:
City: Bunkyo-ku
Zip: 113-8603
Country: Japan

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Name: Research Site

Address:
City: Fukuoka-shi
Zip: 812-8582
Country: Japan

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Name: Research Site

Address:
City: Fukuoka-shi
Zip: 814-0180
Country: Japan

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Name: Research Site

Address:
City: Hiroshima-shi
Zip: 734-8551
Country: Japan

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Name: Research Site

Address:
City: Kawagoe-shi
Zip: 350-8550
Country: Japan

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Name: Research Site

Address:
City: Kitaadachi-gun
Zip: 362-0806
Country: Japan

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Name: Research Site

Address:
City: Kitakyushu-shi
Zip: 807-8555
Country: Japan

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Name: Research Site

Address:
City: Kobe-shi
Zip: 650-0017
Country: Japan

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Name: Research Site

Address:
City: Koto-ku
Zip: 135-8550
Country: Japan

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Name: Research Site

Address:
City: Kumamoto-shi
Zip: 860-8556
Country: Japan

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Name: Research Site

Address:
City: Matsusaka-shi
Zip: 515-8544
Country: Japan

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Name: Research Site

Address:
City: Osaka-shi
Zip: 541-8567
Country: Japan

Facility:
Name: Research Site

Address:
City: Ota-shi
Zip: 373-8550
Country: Japan

Facility:
Name: Research Site

Address:
City: Saitama-shi
Zip: 338-0001
Country: Japan

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Name: Research Site

Address:
City: Shinjuku-ku
Zip: 160-0023
Country: Japan

Facility:
Name: Research Site

Address:
City: Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: Research Site

Address:
City: Yokohama-shi
Zip: 236-0024
Country: Japan

Facility:
Name: Research Site

Address:
City: Yokohama-shi
Zip: 241-8515
Country: Japan

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Name: Research Site

Address:
City: Gyeonggi-do
Zip: 13620
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

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Name: Research Site

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Research Site

Address:
City: Seoul
Zip: 07061
Country: Korea, Republic of

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Name: Research Site

Address:
City: Songpa-gu
Zip: 05505
Country: Korea, Republic of

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Name: Research Site

Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

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Name: Research Site

Address:
City: Kuching
Zip: 93586
Country: Malaysia

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Name: Research Site

Address:
City: Petaling Jaya
Zip: 47500
Country: Malaysia

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Name: Research Site

Address:
City: Lima
Zip: 15036
Country: Peru

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Name: Research Site

Address:
City: Lima
Zip: LIMA 29
Country: Peru

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Name: Research Site

Address:
City: Lima
Zip: Lima 34
Country: Peru

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Name: Research Site

Address:
City: Barcelona
Zip: 8035
Country: Spain

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Name: Research Site

Address:
City: Castelló de la Plana
Zip: 12002
Country: Spain

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Name: Research Site

Address:
City: Las Palmas de Gran Canaria
Zip: 35016
Country: Spain

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Name: Research Site

Address:
City: Madrid
Zip: 28034
Country: Spain

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Name: Research Site

Address:
City: Madrid
Zip: 28046
Country: Spain

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Name: Research Site

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Research Site

Address:
City: Sevilla
Zip: 41013
Country: Spain

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Name: Research Site

Address:
City: Kaohsiung
Zip: 80756
Country: Taiwan

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Name: Research Site

Address:
City: Kaohsiung
Zip: 824
Country: Taiwan

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Name: Research Site

Address:
City: New Taipei City
Zip: 220
Country: Taiwan

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Name: Research Site

Address:
City: Taichung
Zip: 40201
Country: Taiwan

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Name: Research Site

Address:
City: Taichung
Zip: 40705
Country: Taiwan

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Name: Research Site

Address:
City: Tainan
Zip: 736
Country: Taiwan

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Name: Research Site

Address:
City: Taipei
Zip: 23561
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Taoyuan City
Zip: 333423
Country: Taiwan

Facility:
Name: Research Site

Address:
City: Bangkok
Zip: 10700
Country: Thailand

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Name: Research Site

Address:
City: Chiang Mai
Zip: 50200
Country: Thailand

Facility:
Name: Research Site

Address:
City: Dusit
Zip: 10300
Country: Thailand

Facility:
Name: Research Site

Address:
City: Nakhon Ratchasima
Zip: 30000
Country: Thailand

Facility:
Name: Research Site

Address:
City: Songkla
Zip: 90110
Country: Thailand

Facility:
Name: Research Site

Address:
City: Adana
Zip: 01140
Country: Turkey

Facility:
Name: Research Site

Address:
City: Ankara
Zip: 06010
Country: Turkey

Facility:
Name: Research Site

Address:
City: Antalya
Zip: 07100
Country: Turkey

Facility:
Name: Research Site

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Research Site

Address:
City: Izmir
Zip: 35965
Country: Turkey

Facility:
Name: Research Site

Address:
City: Cambridge
Zip: CB2 0QQ
Country: United Kingdom

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Name: Research Site

Address:
City: Edinburgh
Zip: EH4 2XU
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: Greater London
Zip: SW3 6JJ
Country: United Kingdom

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Name: Research Site

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

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Name: Research Site

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

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Name: Research Site

Address:
City: Newcastle upon Tyne
Zip: NE7 7AF
Country: United Kingdom

Facility:
Name: Research Site

Address:
City: Torquay
Zip: TQ2 7AA
Country: United Kingdom

Start date: November 29, 2024

Completion date: March 25, 2030

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/NCT06627647