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

Last updated: March 16, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Pembrolizumab

Paclitaxel

Pemetrexed

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 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: 1200
Treatment Group(s): 5
Primary Treatment: Pembrolizumab
Phase: 3
Study Start date:
October 24, 2023
Estimated Completion Date:
March 23, 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

    Buenos Aires 3435910, 1058
    Argentina

    Site Not Available

  • Research Site

    CABA, C1425
    Argentina

    Site Not Available

  • Research Site

    Ciudad Autónoma de Buenos Aire, C1061ABD
    Argentina

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  • Research Site

    Ciudad de Córdoba, X5800HHW
    Argentina

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    Córdoba, X5800HHW
    Argentina

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  • Research Site

    Córdoba 3860259, 5000
    Argentina

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  • Research Site

    La Plata, B1900AVG
    Argentina

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  • Research Site

    La Plata 3432043, 1900
    Argentina

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  • Research Site

    Rosario, 2000
    Argentina

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  • Research Site

    Rosario 3838583, 2000
    Argentina

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  • Research Site

    Clayton, 3168
    Australia

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  • Research Site

    Clayton 2171400, 3168
    Australia

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  • Research Site

    Fitzroy, 3065
    Australia

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  • Research Site

    Fitzroy 2166584, 3065
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    Heidelberg, 3084
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    Heidelberg 2163654, 3084
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    South Brisbane, 4101
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    South Brisbane 2207259, 4101
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    Sydney, NSW 2145
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    Sydney 2147714, NSW 2145
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    Linz, 4021
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    Linz 2772400, 4021
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    Wels, 4600
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    Wels 2761524, 4600
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    Aalst, 9300
    Belgium

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    Aalst 2803448, 9300
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    Antwerp, 2020
    Belgium

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    Antwerp 2803138, 2020
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    Antwerpen, 2020
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    Gent, 9000
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    Ghent, 9000
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    Ghent 2797656, 9000
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    Barretos, 14784-400
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    Barretos 3470451, 14784-400
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    Curitiba, 80730-150
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    Curitiba 3464975, 80730-150
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    Florianópolis, 88034-000
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    Florianópolis 3463237, 88034-000
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    Fortaleza, 60336-045
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    Fortaleza 3399415, 60336-045
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    Natal, 59075-740
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    Natal 3394023, 59075-740
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    Porto Alegre, 91350200
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    Porto Alegre 3452925, 91350200
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    Rio de Janeiro, 22281-100
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    Rio de Janeiro 3451190, 22281-100
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    Santa Cruz do Sul, 96810-110
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    Santa Cruz do Sul 3450269, 96810-110
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    Sao Paulo, 01221-020
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    São Paulo, 01221-020
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    São Paulo 3448439, 01221-020
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    Calgary, Alberta T2N 5G2
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    Edmonton, Alberta T6G 1Z2
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    Calgary 5913490, Alberta 5883102 T2N 5G2
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    Edmonton 5946768, Alberta 5883102 T6G 1Z2
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    Winnipeg, Manitoba R3E 0V9
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    Winnipeg 6183235, Manitoba 6065171 R3E 0V9
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    Halifax, Nova Scotia B3H 1V7
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    Halifax 6324729, Nova Scotia 6091530 B3H 1V7
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    Barrie, Ontario L4M 6M2
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    Oshawa, Ontario L1G 2B9
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    Toronto, Ontario M4N 3M5
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    Barrie 5894171, Ontario 6093943 L4M 6M2
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    Oshawa 6094578, Ontario 6093943 L1G 2B9
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    Toronto 6167865, Ontario 6093943 M4N 3M5
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    Levis, Quebec G6V 3Z1
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    Lévis, Quebec G6V 3Z1
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    Trois-Rivières, Quebec G8Z 3R0
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    Lévis 6325521, Quebec 6115047 G6V 3Z1
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    Trois-Rivières 6169141, Quebec 6115047 G8Z 3R0
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    Chicoutimi, G7H 5H6
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    Chicoutimi 5921225, G7H 5H6
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    Beijing, 100021
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    Beijing 1816670, 100142
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    Bengbu, 233004
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    Bengbu 1816440, 233004
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    Changchun, 130021
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    Changchun 2038180, 130021
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    Changsha, 410013
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    Changsha 1815577, 410013
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    Chengdu, 610000
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    Chengdu 1815286, 610000
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    Chongqing, 400030
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    Chongqing 1814906, 400030
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    Fuzhou, 350011
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    Fuzhou 1810821, 350011
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    Guangzhou, 510080
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    Guangzhou 1809858, 510080
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    Hangzhou, 310020
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    Hangzhou 1808926, 310022
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    Hefei, 230601
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    Hefei 1808722, 230601
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    Lanzhou, 730000
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    Lanzhou 1804430, 730000
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    Linhai, 317000
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    Linhai 1803422, 317000
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    Linhai 9906214, 317000
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    Linyi, 276001
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    Linyi 1803318, 276001
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    Nanchang, 330006
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    Nanchang 1800163, 330006
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    Nanjing, 210009
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    Nanjing 1799962, 210009
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    Nanning, 530021
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    Nanning 1799869, 530021
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    Shanghai, 200030
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    Shanghai 1796236, 200433
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    Shenzhen, 518116
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    Shenzhen 1795565, 518116
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    Taiyuan, 030000
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    Taiyuan 1793511, 030000
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    Tianjin, 300060
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    Tianjin 1792947, 300060
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    Wuhan, 430022
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    Wuhan 1791247, 430022
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    Xi'an, 710000
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    Xi'an 1790630, 710000
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    Yangzhou, 225001
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    Yangzhou 1787227, 225001
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    Zhengzhou, 450008
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    Zhengzhou 1784658, 450008
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    Olomouc, 77900
    Czechia

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    Olomouc 3069011, 77900
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    Ostrava - Vitkovice, 703 84
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    Prague, 128 08
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    Prague 3067696, 140 59
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    Praha, 128 08
    Czechia

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    Praha 2, 128 08
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    Angers, 49055
    France

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    Angers 3037656, 49055
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    Avignon, 84902
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    Avignon 3035681, 84902
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    Bayonne, 64100
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    Bayonne 3034475, 64100
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    Bordeaux, 33076
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    Bordeaux 3031582, 33076
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    Caen, 14033
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    Caen 3029241, 14033
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    Lille, 59037
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    Lille 2998324, 59037
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    Limoges, 87042
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    Limoges 2998286, 87042
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    Marseille, 13273
    France

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    Marseille 2995469, 13273
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    Montpellier, 34298
    France

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    Montpellier 2992166, 34298
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    Paris, 75248
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    Paris 2988507, 75248
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    Paris Cedex 5, 75248
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    Quimper, 29000
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    Quimper 2984701, 29000
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    Quimper cedex, 29000
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    Reims, 51092
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    Reims 2984114, 51092
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    Saint-Malo, 35403
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    St-Malo, 35403
    France

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    St-Malo 2978640, 35403
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    Strasbourg, 67098
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    Strasbourg 2973783, 67098
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    Strasbourg Cedex, 67098
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    Suresnes, 92150
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    Suresnes 2973675, 92150
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    Toulon Naval, 83800
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    Berlin-Zehlendorf, 14165
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    Bonn, 53113
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    Bonn 2946447, 53127
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    Braunschweig, 38114
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    Braunschweig 2945024, 38114
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    Dresden, 01307
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    Dresden 2935022, 01307
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    Essen, 45136
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    Essen 2928810, 45136
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    Freiburg, 79106
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    Freiburg im Breisgau, 79106
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    Freiburg im Breisgau 2925177, 79106
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    Gauting, 82131
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    Gauting 2922230, 82131
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    Georgsmarienhuette, 49124
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    Georgsmarienhütte, 49124
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    Georgsmarienhütte 2921242, 49124
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    Gütersloh, 33332
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    Gütersloh 2913366, 33332
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    Halle, 06120
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    Halle 2911522, 06120
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    Hamburg, 22087
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    Hamburg 2911298, 22087
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    Heidelberg, 69126
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    Heidelberg 2907911, 69126
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    Immenhausen, 34376
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    Immenhausen 2896279, 34376
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    Koblenz, 56068
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    Koblenz 2886946, 56068
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    Ludwigsburg, 71640
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    Ludwigsburg 2875392, 71640
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    Nuremberg, 90419
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    Nuremberg 2861650, 90419
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    Nürnberg, 90419
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    Tuebingen, 72076
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    Tübingen, 72076
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    Tübingen 2820860, 72076
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    Velbert, 42551
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    Velbert 2817724, 42551
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    Budapest, 1122
    Hungary

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    Budapest 3054643, 1083
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    Debrecen, 4032
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    Debrecen 721472, 4032
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    Deszk, 6772
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    Deszk 721411, 6772
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    Gyöngyös, 3200
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    Gyöngyös 3052040, 3200
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    Gyöngyös - Mátraháza, 3200
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    Győr, 9024
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    Győr 3052009, 9024
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    Kecskemét, 6000
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    Kecskemét 3050434, 6000
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    Pécs, 7624
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    Pécs 3046526, 7624
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    Szekszárd, 7100
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    Szekszárd 3044760, 7100
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    Székesfehérvár, 8000
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    Székesfehérvár 3044774, 8000
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    Törökbálint, 2045
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    Törökbálint 3043778, 2045
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    Bengaluru, 560085
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    Bengaluru 1277333, 560085
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    Delhi, 110029
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    Delhi 1273294, 110029
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    Hyderabad, 500032
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    Hyderabad 1269843, 500032
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    Kolkata, 700016
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    Kolkata 1275004, 700099
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    Mysuru, 570017
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    Mysuru 1262321, 570017
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    Nagpur, 440001
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    Nagpur 1262180, 440001
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    Nashik, 422011
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    Nashik 1261731, 422011
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    New Delhi, 110085
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    New Delhi 1261481, 110085
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    Varanasi, 221005
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    Varanasi 1253405, 221005
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    Bari, 70124
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    Bari 3182351, 70124
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    Bergamo, 24125
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    Bergamo 3182164, 24125
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    Catanzaro, 88100
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    Catanzaro 2525059, 88100
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    Milan, 20162
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    Milan 6951411, 20162
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    Milano, 20162
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    Padova, 35128
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    Padua 3171728, 35128
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    Parma, 43126
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    Parma 3171457, 43126
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    Ravenna 3169561, 48100
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    Roma, 00128
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    Roma 8957247, 00144
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    Bunkyo-ku, 113-8677
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    Bunkyō City, 113-8677
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    Bunkyō City 11790632, 113-8677
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    Fukuoka, 812-8582
    Japan

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  • Research Site

    Fukuoka 1863967, 812-8582
    Japan

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    Site Not Available

  • Research Site

    Dayton 4509884, Ohio 5165418 45428
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Research Site

    Horsham, Pennsylvania 19044
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Research Site

    Horsham 5194302, Pennsylvania 6254927 19044
    United States

    Site Not Available

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Research Site

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Research Site

    Memphis 4641239, Tennessee 4662168 38104
    United States

    Site Not Available

  • Research Site

    Nashville 4644585, Tennessee 4662168 37212
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77090
    United States

    Site Not Available

  • Research Site

    Irving, Texas 75063
    United States

    Site Not Available

  • Research Site

    Lancaster, Texas 75216
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77090
    United States

    Site Not Available

  • Research Site

    Irving 4700168, Texas 4736286 75063
    United States

    Site Not Available

  • Research Site

    Lancaster 4705191, Texas 4736286 75216
    United States

    Site Not Available

  • Research Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Research Site

    Henrico, Virginia 23229
    United States

    Site Not Available

  • Research Site

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Research Site

    Henrico 4763729, Virginia 6254928 23229
    United States

    Site Not Available

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

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