A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

Last updated: March 11, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Pemetrexed

Pembrolizumab

Paclitaxel

Clinical Study ID

NCT05984277
D798AC00001
2023-000056-38
  • Ages > 18
  • All Genders

Study Summary

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Histologically or cytologically documented squamous or non-squamous NSCLC.

  • Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in ThoracicOncology 2016), not amenable to curative surgery or radiation.

  • Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.

  • Absence of documented tumor genomic alteration results from tests conducted as partof standard local practice in any other actionable driver oncogenes for which thereare locally approved targeted first-line therapies.

Exclusion

Key Exclusion Criteria:

  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Raresubtypes are excluded.

  • Spinal cord compression.

  • Symptomatic brain metastases. Brain metastases may be treated or untreated, butparticipants must be asymptomatic and off steroids for at least 14 days prior tostart of study intervention. A minimum of 2 weeks must have elapsed between the endof whole brain radiotherapy and study enrollment.

  • History of another primary malignancy except for:

  1. Malignancy treated with curative intent with no known active disease ≥ 2 yearsbefore the first dose of study intervention and of low potential risk forrecurrence.

  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidenceof disease.

  3. Adequately treated carcinoma in situ without evidence of disease.

  • As judged by the investigator, any condition that would interfere with evaluation ofthe study intervention or interpretation of participant safety or study results.

Study Design

Total Participants: 900
Treatment Group(s): 5
Primary Treatment: Pemetrexed
Phase: 3
Study Start date:
October 24, 2023
Estimated Completion Date:
May 16, 2029

Study Description

Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment. Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig + chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

Connect with a study center

  • Research Site

    Buenos Aires, 1058
    Argentina

    Site Not Available

  • Research Site

    Caba, C1425
    Argentina

    Suspended

  • Research Site

    Ciudad Autónoma de Buenos Aire, C1061ABD
    Argentina

    Site Not Available

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    Ciudad de Córdoba, X5800HHW
    Argentina

    Active - Recruiting

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    Córdoba, 5000
    Argentina

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    La Plata, B1900AVG
    Argentina

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    Rosario, 2000
    Argentina

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    Clayton, 3168
    Australia

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    Fitzroy, 3065
    Australia

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    Heidelberg, 3084
    Australia

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    South Brisbane, 4101
    Australia

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  • Research Site

    Sydney, NSW 2145
    Australia

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    Linz, 4021
    Austria

    Active - Recruiting

  • Research Site

    Wels, 4600
    Austria

    Active - Recruiting

  • Research Site

    Aalst, 9300
    Belgium

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  • Research Site

    Antwerpen, 2020
    Belgium

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  • Research Site

    Gent, 9000
    Belgium

    Active - Recruiting

  • Research Site

    Barretos, 14784-400
    Brazil

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    Curitiba, 80730-150
    Brazil

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    Florianópolis, 88034-000
    Brazil

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    Fortaleza, 60336-045
    Brazil

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    Natal, 59075-740
    Brazil

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    Porto Alegre, 90619-900
    Brazil

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    Rio De Janeiro, 22281-100
    Brazil

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    Santa Cruz do Sul, 96810-110
    Brazil

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    Sao Paulo, 01221-020
    Brazil

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    Calgary, Alberta T2N 5G2
    Canada

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    Edmonton, Alberta T6G 1Z2
    Canada

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    Winnipeg, Manitoba R3E 0V9
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    Halifax, Nova Scotia B3H 1V7
    Canada

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    Barrie, Ontario L4M 6M2
    Canada

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    Oshawa, Ontario L1G 2B9
    Canada

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    Toronto, Ontario M4N 3M5
    Canada

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    Levis, Quebec G6V 3Z1
    Canada

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    Lévis, Quebec G6V 0B8
    Canada

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    Trois-Rivières, Quebec G8Z 3R0
    Canada

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    Chicoutimi, G7H 5H6
    Canada

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    Beijing, 101149
    China

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    Bengbu, 233060
    China

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    Changchun, 130021
    China

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    Changsha, 410013
    China

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    Chengdu, 611135
    China

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    Chongqing, 400030
    China

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    Fuzhou, 350011
    China

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    Guangzhou, 510080
    China

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    Hangzhou, 310020
    China

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    Hefei, 230031
    China

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    Lanzhou, 730000
    China

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    Linhai, 317000
    China

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    Linyi, 276001
    China

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    Nanchang, 330006
    China

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    Nanjing, 210009
    China

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    Nanning, 530021
    China

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    Shanghai, 200433
    China

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    Shenzhen, 518116
    China

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    Taiyuan, 030000
    China

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    Tianjin, 300060
    China

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    Wuhan, 430022
    China

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    Xi'an, 710000
    China

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    Yangzhou, 225001
    China

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    Zhengzhou, 450008
    China

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    Olomouc, 77900
    Czechia

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    Ostrava - Vitkovice, 703 84
    Czechia

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    Praha, 140 59
    Czechia

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    Praha 2, 128 08
    Czechia

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    Angers, 49055
    France

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    Avignon, 84902
    France

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    Bayonne, 64100
    France

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    Bordeaux, 33076
    France

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    Caen, 14033
    France

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    Lille, 59037
    France

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    Limoges, 87042
    France

    Active - Recruiting

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    Marseille, 13273
    France

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    Montpellier, 34298
    France

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    Paris Cedex 5, 75248
    France

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    Quimper, 29000
    France

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    Quimper cedex, 29000
    France

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    Reims, 51092
    France

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    Saint-Malo, 35403
    France

    Active - Recruiting

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    Strasbourg Cedex, 67098
    France

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    Suresnes, 92150
    France

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    Toulon Naval, 83800
    France

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    Berlin-Zehlendorf, 14165
    Germany

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    Bonn, 53113
    Germany

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    Braunschweig, 38114
    Germany

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    Dresden, 01307
    Germany

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    Essen, 45136
    Germany

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    Georgsmarienhuette, 49124
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    Gütersloh, 33332
    Germany

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    Halle, 06120
    Germany

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    Hamburg, 22087
    Germany

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    Heidelberg, 69126
    Germany

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    Immenhausen, 34376
    Germany

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    Koblenz, 56068
    Germany

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    Ludwigsburg, 71640
    Germany

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    Nürnberg, 90419
    Germany

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    Tuebingen, 72076
    Germany

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    Velbert, 42551
    Germany

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    Budapest, 1121
    Hungary

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    Debrecen, 4032
    Hungary

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    Deszk, 6772
    Hungary

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    Gyöngyös, 3200
    Hungary

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    Gyöngyös - Mátraháza, 3200
    Hungary

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    Győr, 9024
    Hungary

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    Kecskemét, 6000
    Hungary

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    Pécs, 7624
    Hungary

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    Szekszárd, 7100
    Hungary

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    Székesfehérvár, 8000
    Hungary

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    Törökbálint, 2045
    Hungary

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    Bengaluru, 560085
    India

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    Delhi, 110029
    India

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    Hyderabad, 500032
    India

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    Kolkata, 700099
    India

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    Mysuru, 570017
    India

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    Nagpur, 440001
    India

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    Nashik, 422011
    India

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    New Delhi, 110085
    India

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    Varanasi, 221005
    India

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    Bari, 70124
    Italy

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    Bergamo, 24125
    Italy

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    Catanzaro, 88100
    Italy

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    Milano, 20162
    Italy

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    Padova, 35128
    Italy

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    Parma, 43126
    Italy

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    Pavia, 27100
    Italy

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    Ravenna, 48100
    Italy

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    Roma, 00144
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    Bunkyo-ku, 113-8677
    Japan

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    Fukuoka-shi, 812-8582
    Japan

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    Kashiwa, 277-8577
    Japan

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    Kawasaki-shi, 216-8511
    Japan

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    Koto-ku, 135-8550
    Japan

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    Matsuyama-shi, 791-0280
    Japan

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    Nagoya-shi, 464-8681
    Japan

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  • Research Site

    Okayama-shi, 700-8558
    Japan

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  • Research Site

    Osaka-shi, 541-8567
    Japan

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  • Research Site

    Osakasayama-shi, 589-8511
    Japan

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  • Research Site

    Sagamihara-shi, 252-0375
    Japan

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  • Research Site

    Sapporo-Shi, 001-0013
    Japan

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  • Research Site

    Sendai-shi, 980-0873
    Japan

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    Ube-shi, 755-0241
    Japan

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  • Research Site

    Yokohama-shi, 241-8515
    Japan

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  • Research Site

    Cheongju-si, 28644
    Korea, Republic of

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  • Research Site

    Incheon, 21565
    Korea, Republic of

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  • Research Site

    Jinju-si, 52727
    Korea, Republic of

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  • Research Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Suwon, 16247
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Suwon-si, 16499
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Ciudad de México, 03840
    Mexico

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  • Research Site

    Culiacan, 80040
    Mexico

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  • Research Site

    Guadalajara, 44680
    Mexico

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  • Research Site

    Mexico City, '14080
    Mexico

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    Monterrey, 64060
    Mexico

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  • Research Site

    Naucalpan, 53100
    Mexico

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  • Research Site

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Research Site

    Groningen, 9728 NT
    Netherlands

    Active - Recruiting

  • Research Site

    Nieuwegein, 3435 CM
    Netherlands

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  • Research Site

    Tilburg, 5042AD
    Netherlands

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    Lublin, 20-090
    Poland

    Active - Recruiting

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    Olsztyn, 10-357
    Poland

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    Poznań, 60-569
    Poland

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  • Research Site

    Przemysl, 37-700
    Poland

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    Radom, 26-600
    Poland

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    Rzeszów, 35-241
    Poland

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    Szklarska Poręba, 58-580
    Poland

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  • Research Site

    Tomaszów Mazowiecki, 97-200
    Poland

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    Toruń, 87-100
    Poland

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  • Research Site

    Warszawa, 01-138
    Poland

    Active - Recruiting

  • Research Site

    Łódź, 90-549
    Poland

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  • Research Site

    Banska Bystrica, 97517
    Slovakia

    Active - Recruiting

  • Research Site

    Bratislava, 833 01
    Slovakia

    Active - Recruiting

  • Research Site

    Kosice, 041 91
    Slovakia

    Active - Recruiting

  • Research Site

    Trnava, 917 75
    Slovakia

    Active - Recruiting

  • Research Site

    Amanzimtoti, 4126
    South Africa

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  • Research Site

    Bloemfontein, 9301
    South Africa

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    George, 6529
    South Africa

    Active - Recruiting

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    Johannesburg, 2196
    South Africa

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    Parktown, 2193
    South Africa

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    Pietermaritzburg, 3245
    South Africa

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  • Research Site

    Pretoria, 0002
    South Africa

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  • Research Site

    Rondebosch, 7700
    South Africa

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    Soweto, 2013
    South Africa

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    Alicante, 03010
    Spain

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    Barcelona, 08003
    Spain

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    Bilbao (Vizcaya), 48013
    Spain

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    Madrid, 28040
    Spain

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  • Research Site

    Málaga, 29011
    Spain

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  • Research Site

    Palma, 07198
    Spain

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  • Research Site

    Hsinchu, 300
    Taiwan

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  • Research Site

    Kaohsiung, 80756
    Taiwan

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  • Research Site

    New Taipei, 220
    Taiwan

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  • Research Site

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 11490
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 110
    Taiwan

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    Taoyuan, 33305
    Taiwan

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    Yunlin, 640
    Taiwan

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    Lampang, 52000
    Thailand

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    Muang, 50200
    Thailand

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    Songkhla, 90110
    Thailand

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    Ankara, 6500
    Turkey

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    Antalya, 07059
    Turkey

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    Diyarbakir, 21280
    Turkey

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    Istanbul, 34722
    Turkey

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    Pamukkale, 20070
    Turkey

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    Çankaya, 06680
    Turkey

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    İzmir, 35100
    Turkey

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    Birmingham, B9 5SS
    United Kingdom

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    Blackpool, FY3 8NR
    United Kingdom

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    Bury St Edmunds, IP332QZ
    United Kingdom

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    Colchester, CO4 5JL
    United Kingdom

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    London, SW10 9NH
    United Kingdom

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    Truro, TR1 3LJ
    United Kingdom

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    Prescott, Arizona 86301
    United States

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    Hot Springs National Park, Arkansas 71913
    United States

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    Springdale, Arkansas 72762
    United States

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    Palo Alto, California 94304
    United States

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    Denver, Colorado 80218-2110
    United States

    Site Not Available

  • Research Site

    Lone Tree, Colorado 80124
    United States

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    Newark, Delaware 19713
    United States

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    Fort Myers, Florida 33901
    United States

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  • Research Site

    Orlando, Florida 32827
    United States

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  • Research Site

    Saint Petersburg, Florida 33705
    United States

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    Tallahassee, Florida 32308
    United States

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  • Research Site

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Research Site

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Research Site

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Research Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40206
    United States

    Active - Recruiting

  • Research Site

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Research Site

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Research Site

    Annapolis, Maryland 21401
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Research Site

    Silver Spring, Maryland 20904
    United States

    Active - Recruiting

  • Research Site

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Research Site

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Research Site

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Research Site

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Research Site

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • Research Site

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Research Site

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Research Site

    Albany, New York 12206
    United States

    Site Not Available

  • Research Site

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Research Site

    Fresh Meadows, New York 11366
    United States

    Site Not Available

  • Research Site

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Research Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Research Site

    Dayton, Ohio 45428
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Research Site

    Horsham, Pennsylvania 19044
    United States

    Active - Recruiting

  • Research Site

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Research Site

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Research Site

    Irving, Texas 75063
    United States

    Site Not Available

  • Research Site

    Lancaster, Texas 75216
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Research Site

    Henrico, Virginia 23229
    United States

    Active - Recruiting

  • Research Site

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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