A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Last updated: July 23, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Placebo

Domvanalimab

Durvalumab

Clinical Study ID

NCT05211895
D9075C00001
2021-004327-32
  • Ages > 18
  • All Genders

Study Summary

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  1. Participant must be ≥ 18 years at the time of screening.

  2. Histologically- or cytologically-documented NSCLC and have been treated withconcurrent CRT for locally advanced, unresectable (Stage III) disease

  3. Provision of a tumour tissue sample obtained prior to CRT

  4. Documented tumour PD-L1 status ≥ 1% by central lab

  5. Documented EGFR and ALK wild-type status (local or central).

  6. Patients must not have progressed following definitive, platinum-based, concurrentchemoradiotherapy

  7. Participants must have received at least 2 cycles of platinum-based chemotherapyconcurrent with radiation therapy

  8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapyshould be administered by intensity modulated RT (preferred) or 3D-conformingtechnique.

  9. WHO performance status of 0 or 1 at randomization

  10. Adequate organ and marrow function

Exclusion

EXCLUSION CRITERIA:

  1. History of another primary malignancy, except for:
  • Malignancies treated with curative intent and adequate follow-up with no knownactive disease and have not required active treatment within the past 3 yearsbefore the first dose of study intervention and of low potential risk ofrecurrence.

  • Adequately resected non melanoma skin cancer or lentigo maligna withoutevidence of disease .

  • Adequately treated carcinoma in situ, including Ta tumors without evidence ofdisease.

  1. Mixed small cell and non-small cell lung cancer histology.

  2. Participants who receive sequential (not inclusive of induction) chemoradiationtherapy for locally advanced (Stage III) unresectable NSCLC.

  3. Participants with locally advanced (Stage III) unresectable NSCLC who haveprogressed during platinum-based cCRT.

  4. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).

  5. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.

  6. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathicpneumonitis - regardless of time of onset prior to randomisation. Evidence of activenon-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active orrecently treated pleural effusion, or current pulmonary fibrosis

  7. Active or prior documented autoimmune or inflammatory disorders (with exceptions)

  8. Active EBV infection, or known or suspected chronic active EBV infection atscreening

  9. Current or prior use of immunosuppressive medication within 14 days before the firstdose of durvalumab.

Study Design

Total Participants: 860
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 18, 2022
Estimated Completion Date:
September 12, 2030

Connect with a study center

  • Research Site

    Brussels, 1160
    Belgium

    Active - Recruiting

  • Research Site

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Research Site

    Haine-Saint-Paul, 7100
    Belgium

    Active - Recruiting

  • Research Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Research Site

    Liege, 4000
    Belgium

    Active - Recruiting

  • Research Site

    Sint-Niklaas, 9100
    Belgium

    Active - Recruiting

  • Research Site

    Barretos, 14784-400
    Brazil

    Active - Recruiting

  • Research Site

    Londrina, 86015-520
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 91350200
    Brazil

    Active - Recruiting

  • Research Site

    Porto Velho, 76834-899
    Brazil

    Active - Recruiting

  • Research Site

    Rio de Janeiro, 20231-050
    Brazil

    Active - Recruiting

  • Research Site

    Santo Andre, 09060-650
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 01221-900
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 04556-100
    Brazil

    Site Not Available

  • Research Site

    Taubaté, 12030-200
    Brazil

    Active - Recruiting

  • Research Site

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Research Site

    Kelowna, British Columbia V1Y 5L3
    Canada

    Active - Recruiting

  • Research Site

    Laval, Quebec H7M 3L9
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Research Site

    Las Condes, 7560908
    Chile

    Active - Recruiting

  • Research Site

    Puerto Montt, 5500243
    Chile

    Active - Recruiting

  • Research Site

    Santiago, 7630370
    Chile

    Active - Recruiting

  • Research Site

    Temuco, 4810218
    Chile

    Active - Recruiting

  • Research Site

    Baoding, 071000
    China

    Site Not Available

  • Research Site

    Baotou, 140400
    China

    Site Not Available

  • Research Site

    Beijing, 100142
    China

    Site Not Available

  • Research Site

    Bengbu, 233060
    China

    Site Not Available

  • Research Site

    Changsha, 430033
    China

    Site Not Available

  • Research Site

    Chengdu, 610041
    China

    Site Not Available

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    Chongqing, 400042
    China

    Site Not Available

  • Research Site

    Dalian, 116001
    China

    Site Not Available

  • Research Site

    Dongguan, 523009
    China

    Site Not Available

  • Research Site

    Foshan, 528000
    China

    Site Not Available

  • Research Site

    Guangzhou, 510120
    China

    Site Not Available

  • Research Site

    Hangzhou, 310009
    China

    Site Not Available

  • Research Site

    Hefei, 230001
    China

    Site Not Available

  • Research Site

    Jinan, 250021
    China

    Site Not Available

  • Research Site

    Ningbo, 315010
    China

    Site Not Available

  • Research Site

    Qingdao, 266042
    China

    Site Not Available

  • Research Site

    Shandong,
    China

    Site Not Available

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    Shanghai, 200030
    China

    Site Not Available

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    Shenzhen, 518036
    China

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    Suzhou, 215006
    China

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    Taiyuan, 030000
    China

    Site Not Available

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    Tianjin, 300000
    China

    Site Not Available

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    Xi'an, 710061
    China

    Site Not Available

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    Xiamen, 361003
    China

    Site Not Available

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    Yinchuan, 750004
    China

    Site Not Available

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    Aix en Provence, 13616
    France

    Active - Recruiting

  • Research Site

    Angers, 49055
    France

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  • Research Site

    Bobigny, 93000
    France

    Active - Recruiting

  • Research Site

    Clermont-Ferrand, 63000
    France

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  • Research Site

    Lille, 59000
    France

    Active - Recruiting

  • Research Site

    Paris Cedex 14, 75014
    France

    Active - Recruiting

  • Research Site

    Pau cedex, 6400
    France

    Active - Recruiting

  • Research Site

    Quimper, 29000
    France

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  • Research Site

    Quimper cedex, 29000
    France

    Site Not Available

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    Saint Gregoire, 35760
    France

    Active - Recruiting

  • Research Site

    Saint-Quentin cedex, 02321
    France

    Active - Recruiting

  • Research Site

    Vantoux, 57070
    France

    Active - Recruiting

  • Research Site

    Villeurbanne, 69100
    France

    Active - Recruiting

  • Research Site

    Berlin, 12351
    Germany

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  • Research Site

    Berlin-Zehlendorf, 14165
    Germany

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  • Research Site

    Braunschweig, 38114
    Germany

    Active - Recruiting

  • Research Site

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Research Site

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Research Site

    Essen, 45147
    Germany

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  • Research Site

    Georgsmarienhuette, 49124
    Germany

    Site Not Available

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    Giessen, 35392
    Germany

    Active - Recruiting

  • Research Site

    Halle, 06120
    Germany

    Active - Recruiting

  • Research Site

    Hamburg, 21075
    Germany

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    Homburg, 66421
    Germany

    Site Not Available

  • Research Site

    Koblenz, 56073
    Germany

    Active - Recruiting

  • Research Site

    Krefeld, 47805
    Germany

    Active - Recruiting

  • Research Site

    Köln, 51109
    Germany

    Active - Recruiting

  • Research Site

    Löwenstein, 74245
    Germany

    Active - Recruiting

  • Research Site

    Moers, 47441
    Germany

    Terminated

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    München, 81675
    Germany

    Site Not Available

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    Regensburg, 93049
    Germany

    Active - Recruiting

  • Research Site

    Tübingen, 72076
    Germany

    Active - Recruiting

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    Athens, 18547
    Greece

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  • Research Site

    Holargos, Athens, 155 62
    Greece

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    Thessaloniki, 56 429
    Greece

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    Hong Kong, 150001
    Hong Kong

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    Budapest, 1122
    Hungary

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  • Research Site

    Deszk, 6772
    Hungary

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    Győr, 9024
    Hungary

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    Salgótarján, 3100
    Hungary

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    Székesfehérvár, 8000
    Hungary

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    Törökbálint, 2045
    Hungary

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  • Research Site

    Ahmedabad, 380054
    India

    Completed

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    Bangalore, 560064
    India

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    Delhi, 110085
    India

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    Gurgaon, 122001
    India

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    Howrah, 711103
    India

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    Hyderabad, 500032
    India

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    Jaipur, 302022
    India

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  • Research Site

    Kolkata, 700160
    India

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  • Research Site

    Marg Jaipur, 302004
    India

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  • Research Site

    Mohali, 160055
    India

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  • Research Site

    Namakkal, 637001
    India

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    New Delhi, 110005
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    Rohini, 110 085
    India

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    Varanasi, 221005
    India

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    Bergamo, 24127
    Italy

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    Roma, 00144
    Italy

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    Rozzano, 20089
    Italy

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    Udine, 33100
    Italy

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    Bunkyo-ku, 113-8677
    Japan

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  • Research Site

    Chiba-shi, 260-8717
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka-shi, 812-8582
    Japan

    Active - Recruiting

  • Research Site

    Hidaka-shi, 350-1298
    Japan

    Active - Recruiting

  • Research Site

    Hirosaki-shi, 036-8563
    Japan

    Active - Recruiting

  • Research Site

    Itabashi-ku, 173-0003
    Japan

    Active - Recruiting

  • Research Site

    Kashihara-shi, 634-8522
    Japan

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  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Kumamoto-shi, 860-8556
    Japan

    Active - Recruiting

  • Research Site

    Matsuyama-shi, 791-0280
    Japan

    Active - Recruiting

  • Research Site

    Nagoya-shi, 464-8681
    Japan

    Active - Recruiting

  • Research Site

    Osaka-shi, 545-8586
    Japan

    Active - Recruiting

  • Research Site

    Osakasayama-shi, 589-8511
    Japan

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  • Research Site

    Sapporo-shi, 003-0804
    Japan

    Active - Recruiting

  • Research Site

    Sunto-gun, 411-8777
    Japan

    Active - Recruiting

  • Research Site

    Tokyo, 104-0045
    Japan

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  • Research Site

    Yokohama-shi, 221-0855
    Japan

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  • Research Site

    Daegu, 42415
    Korea, Republic of

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  • Research Site

    Goyang-si, 10408
    Korea, Republic of

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  • Research Site

    Gyeongsangnam-do, 52727
    Korea, Republic of

    Site Not Available

  • Research Site

    Incheon, 21431
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Jinju-si, 52727
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 07061
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Suwon, 16247
    Korea, Republic of

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  • Research Site

    Johor Bahru, 81100
    Malaysia

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  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Research Site

    Selangor, 46050
    Malaysia

    Active - Recruiting

  • Research Site

    Aguascalientes, 20230
    Mexico

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  • Research Site

    Cdmx, 03810
    Mexico

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  • Research Site

    Chihuahua, 31207
    Mexico

    Active - Recruiting

  • Research Site

    Guadalajara, 44280
    Mexico

    Site Not Available

  • Research Site

    Monterrey, 64460
    Mexico

    Site Not Available

  • Research Site

    Oaxaca, 68020
    Mexico

    Active - Recruiting

  • Research Site

    San Pedro Garza Garcia, 66220
    Mexico

    Site Not Available

  • Research Site

    Sonora, 83207
    Mexico

    Site Not Available

  • Research Site

    Veracruz, 91900
    Mexico

    Site Not Available

  • Research Site

    Bodø, 8092
    Norway

    Active - Recruiting

  • Research Site

    Gjøvik, 2819
    Norway

    Active - Recruiting

  • Research Site

    Oslo, 0379
    Norway

    Active - Recruiting

  • Research Site

    Trondheim, 0730
    Norway

    Active - Recruiting

  • Research Site

    Bacolod, 6100
    Philippines

    Active - Recruiting

  • Research Site

    Iloilo City, 5000
    Philippines

    Active - Recruiting

  • Research Site

    Muntinlupa City, 1780
    Philippines

    Active - Recruiting

  • Research Site

    Pasig City, 1605
    Philippines

    Active - Recruiting

  • Research Site

    Quezon City, 1100
    Philippines

    Active - Recruiting

  • Research Site

    Białystok, 15-027
    Poland

    Active - Recruiting

  • Research Site

    Gliwice, 44-102
    Poland

    Site Not Available

  • Research Site

    Katowice, 40-074
    Poland

    Suspended

  • Research Site

    Warszawa, 02-781
    Poland

    Site Not Available

  • Research Site

    Wroclaw, 53-413
    Poland

    Active - Recruiting

  • Research Site

    Zielona Góra, 65-046
    Poland

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  • Research Site

    Łódź, 93-513
    Poland

    Active - Recruiting

  • Research Site

    Bucuresti, 050098
    Romania

    Active - Recruiting

  • Research Site

    Craiova, 200542
    Romania

    Active - Recruiting

  • Research Site

    Floresti,
    Romania

    Active - Recruiting

  • Research Site

    Iasi, 700483
    Romania

    Active - Recruiting

  • Research Site

    Oradea, 410001
    Romania

    Active - Recruiting

  • Research Site

    Sibiu, 550245
    Romania

    Active - Recruiting

  • Research Site

    Suceava, 720214
    Romania

    Active - Recruiting

  • Research Site

    Timisoara, 300166
    Romania

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  • Research Site

    Barnaul, 656049
    Russian Federation

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  • Research Site

    Kazan, 420029
    Russian Federation

    Site Not Available

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    Moscow, 121205
    Russian Federation

    Site Not Available

  • Research Site

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Research Site

    Novisibirsk, 630082
    Russian Federation

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  • Research Site

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • Research Site

    Perm, 614990
    Russian Federation

    Site Not Available

  • Research Site

    Saint Petersburg, 196006
    Russian Federation

    Site Not Available

  • Research Site

    Tomsk, 634028
    Russian Federation

    Site Not Available

  • Research Site

    Amanzimtoti, 4126
    South Africa

    Active - Recruiting

  • Research Site

    Cape Town, 7570
    South Africa

    Site Not Available

  • Research Site

    Johannesburg, 2196
    South Africa

    Active - Recruiting

  • Research Site

    Parktown, 2193
    South Africa

    Terminated

  • Research Site

    Pretoria, 0084
    South Africa

    Active - Recruiting

  • Research Site

    Bilbao (Vizcaya), 48013
    Spain

    Active - Recruiting

  • Research Site

    Castello de la Plana, 12002
    Spain

    Active - Recruiting

  • Research Site

    Cordoba, 14004
    Spain

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  • Research Site

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Research Site

    El Palmar, 30120
    Spain

    Active - Recruiting

  • Research Site

    Palma de Mallorca, 07010
    Spain

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  • Research Site

    Sabadell (Barcelona), 08208
    Spain

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  • Research Site

    Basel, 4031
    Switzerland

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  • Research Site

    Bern, CH-3010
    Switzerland

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  • Research Site

    Lausanne, 1011
    Switzerland

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  • Research Site

    Hsinchu, 300
    Taiwan

    Active - Recruiting

  • Research Site

    New Taipei, 220216
    Taiwan

    Active - Recruiting

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    New-Taipei, 220216
    Taiwan

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    Taichung, 40447
    Taiwan

    Active - Recruiting

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    Tainan,
    Taiwan

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    Taipei, 11217
    Taiwan

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    Taoyuan, 333
    Taiwan

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    Bangkok, 10400
    Thailand

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    Hat Yai, 90110
    Thailand

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    Adapazari, 54290
    Turkey

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    Ankara, 6100
    Turkey

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    Antalya, 07058
    Turkey

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    Edirne, 22030
    Turkey

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    Istanbul, 34098
    Turkey

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    Izmir, 35360
    Turkey

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    Konya, 42080
    Turkey

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    Çankaya, 06680
    Turkey

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    İstanbul, 34662
    Turkey

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    Birmingham, B9 5SS
    United Kingdom

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    Brighton, BN2 5BE
    United Kingdom

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    Cambridge, CB2 0QQ
    United Kingdom

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    Cardiff, CF14 2TL
    United Kingdom

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    Cheltenham, GL53 7AN
    United Kingdom

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    High Heaton/Newcastle Upon Tyn, NE7 7DN
    United Kingdom

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    Leeds, LS 9 7TF
    United Kingdom

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    London, SE1 9RT
    United Kingdom

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    Nottingham, NG5 1PB
    United Kingdom

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    Truro, TR1 3LJ
    United Kingdom

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    Chandler, Arizona 85224
    United States

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  • Research Site

    Mesa, Arizona 85206
    United States

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    Phoenix, Arizona 85054
    United States

    Suspended

  • Research Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Research Site

    Santa Rosa, California 95403
    United States

    Active - Recruiting

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    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • Research Site

    Fort Lauderdale, Florida 33308
    United States

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    Jacksonville, Florida 32224
    United States

    Suspended

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    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Research Site

    Saint Augustine, Florida 32086
    United States

    Active - Recruiting

  • Research Site

    Macon, Georgia 31217
    United States

    Suspended

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    Elmhurst, Illinois 60126
    United States

    Suspended

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    Maywood, Illinois 60153
    United States

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    Naperville, Illinois 60540
    United States

    Suspended

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    Louisville, Kentucky 40202
    United States

    Active - Recruiting

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    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Research Site

    Silver Spring, Maryland 20910
    United States

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    Detroit, Michigan 48202
    United States

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    Minneapolis, Minnesota 55407
    United States

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    Rochester, Minnesota 55905
    United States

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    Saint Paul, Minnesota 55102
    United States

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    Reno, Nevada 89511
    United States

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    Berkeley Heights, New Jersey 07922
    United States

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    East Brunswick, New Jersey 08816
    United States

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    Florham Park, New Jersey 07932
    United States

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    Buffalo, New York 14221
    United States

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    Johnson City, New York 13790
    United States

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    Asheville, North Carolina 28805
    United States

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    Charlotte, North Carolina 28204
    United States

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    Winston-Salem, North Carolina 27157
    United States

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    Columbus, Ohio 43219
    United States

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    Oklahoma City, Oklahoma 73102
    United States

    Active - Recruiting

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    Pittsburgh, Pennsylvania 15212
    United States

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    Charleston, South Carolina 29401
    United States

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    Nashville, Tennessee 37232
    United States

    Suspended

  • Research Site

    Fort Sam Houston, Texas 78234
    United States

    Active - Recruiting

  • Research Site

    Kingwood, Texas 77339
    United States

    Suspended

  • Research Site

    Arlington, Virginia 22205
    United States

    Active - Recruiting

  • Research Site

    Fort Belvoir, Virginia 22060
    United States

    Active - Recruiting

  • Research Site

    Spokane Valley, Washington 99216
    United States

    Active - Recruiting

  • Research Site

    Appleton, Wisconsin 54911
    United States

    Active - Recruiting

  • Research Site

    Hanoi, 10000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh city, 700000
    Vietnam

    Site Not Available

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