A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

Last updated: April 15, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Docetaxel

Ceralasertib

Durvalumab

Clinical Study ID

NCT05450692
D533BC00001
2022-000493-26
  • Ages 18-130
  • All Genders

Study Summary

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically documented NSCLC that is locally advanced ormetastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.

  • Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.

  • Documented radiological PD whilst on or after receiving the most recent treatmentregimen.

  • Eligible for second- or third-line therapy and must have received an anti-PD-(L)1therapy and a platinum doublet containing therapy for locally advanced or metastaticNSCLC either separately or in combination.

  • Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO)performance status of 0 or 1.

  • Adequate organ function and marrow reserve

  • Minimum life expectancy of 12 weeks.

  • Body weight > 30 kg and no cancer-associated cachexia.

  • Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

Exclusion

Exclusion Criteria:

  • Participant with mixed SCLC and NSCLC histology.

  • History of another primary malignancy except for malignancy treated with curativeintent with no known active disease ≥ 5 years before the first dose of studyintervention.

  • Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.

  • Active or prior documented autoimmune or inflammatory disorders.

  • Participants who have received more than one line of prior anti-PD-(L)1, eitheralone or in any combination.

  • Participants:

  1. Must not have experienced a toxicity that led to permanent discontinuation ofthe prior anti-PD(L)1 therapy.

  2. All AEs while receiving prior anti-PD(L)1 therapy must have completelyresolved.

  3. Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) oran immune-related neurologic or ocular AE of any grade while receiving prioranti-PD(L)1 therapy.

  4. Must not have required the use of additional immunosuppression other thancorticosteroids for the management of an AE, not have experienced recurrence ofan AE if re-challenged, and not currently require maintenance doses of > 10 mgprednisone or equivalent per day.

  • Participants who have received more than one prior line of platinum-basedchemotherapy in metastatic setting.

  • Participants who have received a prior ataxia telangiectasia and Rad3-relatedprotein (ATR) inhibitor.

Study Design

Total Participants: 594
Treatment Group(s): 3
Primary Treatment: Docetaxel
Phase: 3
Study Start date:
September 15, 2022
Estimated Completion Date:
December 31, 2027

Study Description

This study will consist of two treatment arms (Groups A and B).

Participants will be randomised in a 1:1 ratio to one of the two treatment groups:

  • Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously.

  • Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.

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, C1280AEB
    Argentina

    Site Not Available

  • Research Site

    Cordoba, 5000
    Argentina

    Site Not Available

  • Research Site

    Pergamino, B2700CPM
    Argentina

    Site Not Available

  • Research Site

    Pergamino 3841490, B2700CPM
    Argentina

    Site Not Available

  • Research Site

    Rosario, S2000DSV
    Argentina

    Site Not Available

  • Research Site

    Rosario 3838583, S2000KZE
    Argentina

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  • Research Site

    San Juan, 5400
    Argentina

    Site Not Available

  • Research Site

    San Juan 3837213, 5400
    Argentina

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  • Research Site

    Viedma, R8500JYJ
    Argentina

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    Elizabeth Vale, 5112
    Australia

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  • Research Site

    Elizabeth Vale 9973185, 5112
    Australia

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    Lismore, 2480
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    Lismore 2160063, 2480
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    Murdoch, 6150
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    Murdoch 8349091, 6150
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    South Brisbane, 4101
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    South Brisbane 2207259, 4101
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    Wendouree, 3355
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    Wollongong, 2500
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    Wollongong 2171507, 2500
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    Charleroi, 6000
    Belgium

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    Charleroi 2800481, 6000
    Belgium

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    Gent, 9000
    Belgium

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    Ghent, 9000
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    Ghent 2797656, 9000
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    Libramont-Chevigny, 6800
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    Roeselare, 8800
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    Roeselare 2787889, 8800
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    Fortaleza, 60810-180
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    Fortaleza 3399415, 60810-180
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    Porto Alegre, 90610-000
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    Porto Alegre 3452925, 90110-270
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    Salvador, 40170-110
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    Salvador 3450554, 40170-110
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    Sao Paulo, 09323-900
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    São Paulo, 01246-000
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    São Paulo 3448439, 01246-000
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    Vancouver, British Columbia VSZ 4E6
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    Vancouver 6173331, British Columbia 5909050 VSZ 4E6
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    London, Ontario N6A 4L6
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    Newmarket, Ontario L3Y 2P9
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    Newmarket 6087701, Ontario 6093943 L3Y 2P9
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    Chicoutimi, Quebec G7H 7P2
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    Québec, Quebec G1V 4G5
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    Rimouski, Quebec G5L 5T1
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    Chicoutimi 5921225, Quebec 6115047 G7H 7P2
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    Montreal 6077243, Quebec 6115047 H2L 4M1
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    Québec 6325494, Quebec 6115047 G1V 4G5
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    Rimouski 6354895, Quebec 6115047 G5L 5T1
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    Quebec, G1V 4G5
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    Baoding, 071000
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    Baoding 1816971, 071000
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    Beijing, 100021
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    Beijing 1816670, 100021
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    Changsha, 410008
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    Changsha 1815577, 410008
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    Chengdu, 610041
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    Chengdu 1815286, 610041
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    Chongqing, 400016
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    Deyang, 618000
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    Deyang 1812961, 618000
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    Ganzhou, 341099
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    Guangzhou, 510080
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    Guangzhou 1809858, 510080
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    Hangzhou, 310009
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    Hangzhou 1808926, 310009
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    Hefei, 230001
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    Hefei 1808722, 230001
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    Jinan, 250013
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    Linyi, 276000
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    Linyi 1803318, 276000
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    Nanchang, 330000
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    Nanchang 1800163, 330000
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    Nanjing, 210029
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    Wuhan, 430000
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    Yantai, 264000
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    Zhanjiang, 524001
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    Zhanjiang 1784990, 524001
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    Zhengzhou, 450008
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    Zhengzhou 1784658, 450008
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    Angers, 49933
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    Angers 3037656, 49933
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    Clamart, 92140
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    Clamart 3024783, 92140
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    Clamart Cedex, 92140
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    Clermont Ferrand, 63011
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    Clermont-Ferrand, 63011
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    Clermont-Ferrand 3024635, 63011
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    Creteil, 94010
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    Créteil, 94010
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    Créteil 3022530, 94010
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    Lyon, 69373
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    Lyon 2996944, 69373
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    Montpellier, 34070
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    Montpellier 2992166, 34070
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    Nantes, 44093
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    Nantes 2990969, 44093
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    Nantes cedex 1, 44093
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    Paris, 75014
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    Paris 2988507, 75014
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    Pessac, 33604
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    Pessac 2987805, 33604
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    Saint Herblain Cedex, 44805
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    Saint-Herblain, 44805
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    Saint-Herblain 2979590, 44805
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    Saint-Quentin, 02321
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    Saint-Quentin 2977295, 02321
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    Saint-Quentin cedex, 02321
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    Vantoux, 57070
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    Vantoux 2970764, 57070
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    Villefranche Sur Saone, 69655
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    Villefranche-sur-Saône, 69655
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    Villefranche-sur-Saône 2968748, 69655
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    Villejuif, 94805
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    Villejuif 2968705, 94805
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    Villejuif Cedex, 94805
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    Berlin, 12351
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    Berlin 2950159, 12351
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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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    Karlsruhe, 76137
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    Karlsruhe 2892794, 76137
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    Kempten, 87439
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    Kempten 2891620, 87439
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    Löwenstein, 74245
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    Löwenstein 2875656, 74245
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    Moers, 47441
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    Moers 2870221, 47441
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    Münster, 48147
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    Ulm, 89081
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    Hong Kong, 999077
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    Hong Kong 1819729, 999077
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    King's Park, 150001
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    Tun Mun,
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    Budapest, 1121
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    Budapest 3054643, 1121
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    Székesfehérvár, 8000
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    Székesfehérvár 3044774, 8000
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    Törökbálint, 2045
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    Zalaegerszeg, 8900
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    Bhubaneswar, 751019
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    Jaipur, 302017
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    Jaipur 1269515, 302017
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    Mumbai, 400 012
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    Pune, 411001
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    Pune 1259229, 411001
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    Surat 1255364, 395002
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    Cork, T12 DV56
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    Cork 2965140, T12 DV56
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    Dublin,
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    Dublin 2964574,
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    Dublin 4,
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    Limerick, V94 F858
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    Limerick 2962943, V94 F858
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    Aviano, 33081
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    Aviano 3182635, 33081
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    Catania, 95123
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    Livorno, 57124
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    Livorno 3174659, 57124
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    Meldola, 47014
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    Meldola 3173635, 47014
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    Milan, 20133
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    Milan 6951411, 20133
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    Monza, 20900
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    Monza 3172629, 20900
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    Naples, 80131
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    Napoli, 80131
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    Napoli 9031661, 80131
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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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    Perugia, 06129
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    Perugia 3171180, 06129
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    Roma, 00128
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    Roma 8957247, 00128
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    Rozzano, 20089
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    Rozzano 3168837, 20089
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    Verona, 37126
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    Verona 3164527, 37126
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    Bunkyo-ku, 113-8431
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    Bunkyō City, 113-8431
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    Bunkyō City 11790632, 113-8431
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    Chuo-ku, 104-0045
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    Chūōku, 104-0045
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    Chūōku 10262791, 104-0045
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    Hiroshima-shi, 730-8518
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    Kurashiki-shi, 710-8602
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    Kōtoku, 135-8550
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    Kōtoku 2128852, 135-8550
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    Matsuyama, 791-0280
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    Matsuyama 1926099, 791-0280
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    Nagoya 1856057, 460-0001
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    Sendai, 980-0873
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    Sendai 2111149, 980-0873
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    Poznan 3088171, 60-693
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    Site Not Available

  • Research Site

    Skórzewo 3085750, 60-185
    Poland

    Site Not Available

  • Research Site

    Toruń, 87-100
    Poland

    Site Not Available

  • Research Site

    Bucharest, 022328
    Romania

    Site Not Available

  • Research Site

    Bucharest 683506, 022328
    Romania

    Site Not Available

  • Research Site

    Bucuresti, 031422
    Romania

    Site Not Available

  • Research Site

    Cluj-Napoca, 400641
    Romania

    Site Not Available

  • Research Site

    Cluj-Napoca 681290, 400015
    Romania

    Site Not Available

  • Research Site

    Constanta, 900591
    Romania

    Site Not Available

  • Research Site

    Craiova, 200385
    Romania

    Site Not Available

  • Research Site

    Craiova 680332, 200347
    Romania

    Site Not Available

  • Research Site

    Floresti, 407280
    Romania

    Site Not Available

  • Research Site

    Floreşti, 407280
    Romania

    Site Not Available

  • Research Site

    Floreşti 678063, 407280
    Romania

    Site Not Available

  • Research Site

    Oradea, 410469
    Romania

    Site Not Available

  • Research Site

    Oradea 671768, 410469
    Romania

    Site Not Available

  • Research Site

    Timisoara, 300166
    Romania

    Site Not Available

  • Research Site

    Timișoara, 300166
    Romania

    Site Not Available

  • Research Site

    Timișoara 665087, 300166
    Romania

    Site Not Available

  • Research Site

    Belgrad, 11000
    Serbia

    Site Not Available

  • Research Site

    Belgrade, 11080
    Serbia

    Site Not Available

  • Research Site

    Belgrade 792680, 11080
    Serbia

    Site Not Available

  • Research Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Research Site

    Cheongju-si, 28644
    South Korea

    Site Not Available

  • Research Site

    Cheongju-si 1845604, 28644
    South Korea

    Site Not Available

  • Research Site

    Seoul, 07061
    South Korea

    Site Not Available

  • Research Site

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Research Site

    Suwon, 16247
    South Korea

    Site Not Available

  • Research Site

    Suwon 1835553, 16247
    South Korea

    Site Not Available

  • Research Site

    A Coruña, 15006
    Spain

    Site Not Available

  • Research Site

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Research Site

    Barcelona, 8035
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 8003
    Spain

    Site Not Available

  • Research Site

    Castello de la Plana, 12002
    Spain

    Site Not Available

  • Research Site

    Castellon, 12002
    Spain

    Site Not Available

  • Research Site

    Castellon 2519752, 12002
    Spain

    Site Not Available

  • Research Site

    Cordoba, 14004
    Spain

    Site Not Available

  • Research Site

    Córdoba, 14004
    Spain

    Site Not Available

  • Research Site

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Research Site

    Hospitalet deLlobregat, 08907
    Spain

    Site Not Available

  • Research Site

    Madrid, 28040
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Research Site

    Majadahonda, 28222
    Spain

    Site Not Available

  • Research Site

    Malaga, 29009
    Spain

    Site Not Available

  • Research Site

    Málaga, 29009
    Spain

    Site Not Available

  • Research Site

    Málaga 2514256, 29009
    Spain

    Site Not Available

  • Research Site

    Orense, 32005
    Spain

    Site Not Available

  • Research Site

    Ourense, 32005
    Spain

    Site Not Available

  • Research Site

    Ourense 3114965, 32005
    Spain

    Site Not Available

  • Research Site

    Palma de Mallorca, 07198
    Spain

    Site Not Available

  • Research Site

    Palma de Mallorca 2512989, 07198
    Spain

    Site Not Available

  • Research Site

    Pamplona, 31008
    Spain

    Site Not Available

  • Research Site

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Research Site

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Research Site

    Pozuelo de Alarcón, 28223
    Spain

    Site Not Available

  • Research Site

    Pozuelo de Alarcón 3112989, 28223
    Spain

    Site Not Available

  • Research Site

    Sabadell, 08208
    Spain

    Site Not Available

  • Research Site

    Sabadell 3111199, 08208
    Spain

    Site Not Available

  • Research Site

    Servilla, 41014
    Spain

    Site Not Available

  • Research Site

    Zaragoza, 50009
    Spain

    Site Not Available

  • Research Site

    Zaragoza 3104324, 50009
    Spain

    Site Not Available

  • Research Site

    Taichung, 40201
    Taiwan

    Site Not Available

  • Research Site

    Taichung 1668399, 40201
    Taiwan

    Site Not Available

  • Research Site

    Tainan, 704
    Taiwan

    Site Not Available

  • Research Site

    Tainan 1668355, 704
    Taiwan

    Site Not Available

  • Research Site

    Tainan City 1668355, 704
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 11217
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 11217
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333423
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan City, 333423
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District, 333423
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District 1667905, 333423
    Taiwan

    Site Not Available

  • Research Site

    Yunlin, 640
    Taiwan

    Site Not Available

  • Research Site

    Bristol, BS2 8ED
    United Kingdom

    Site Not Available

  • Research Site

    Guildford,
    United Kingdom

    Site Not Available

  • Research Site

    Guildford 2647793,
    United Kingdom

    Site Not Available

  • Research Site

    Metropolitan Borough of Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • Research Site

    Metropolitan Borough of Wirral 7733088, CH63 4JY
    United Kingdom

    Site Not Available

  • Research Site

    Stevenage, SG1 4AB
    United Kingdom

    Site Not Available

  • Research Site

    Stevenage 2636940, SG1 4AB
    United Kingdom

    Site Not Available

  • Research Site

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Research Site

    Sutton 2636503, SM2 5PT
    United Kingdom

    Site Not Available

  • Research Site

    Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • Research Site

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • Research Site

    Mobile, Alabama 36607
    United States

    Site Not Available

  • Research Site

    Mobile 4076598, Alabama 4829764 36607
    United States

    Site Not Available

  • Research Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Research Site

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Research Site

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Research Site

    Chandler 5289282, Arizona 5551752 85224
    United States

    Site Not Available

  • Research Site

    Cerritos, California 90703
    United States

    Site Not Available

  • Research Site

    Corona, California 92882
    United States

    Site Not Available

  • Research Site

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90017
    United States

    Site Not Available

  • Research Site

    Whittier, California 90603
    United States

    Site Not Available

  • Research Site

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • Research Site

    Los Angeles 5368361, California 5332921 90017
    United States

    Site Not Available

  • Research Site

    Whittier 5409059, California 5332921 90603
    United States

    Site Not Available

  • Research Site

    Greeley, Colorado 80631
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Research Site

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Research Site

    Orlando 4167147, Florida 4155751 32804
    United States

    Site Not Available

  • Research Site

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Research Site

    Athens, Georgia 30607
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Research Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Research Site

    Athens 4180386, Georgia 4197000 30607
    United States

    Site Not Available

  • Research Site

    Atlanta 4180439, Georgia 4197000 30318
    United States

    Site Not Available

  • Research Site

    Peoria, Illinois 61602
    United States

    Site Not Available

  • Research Site

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Research Site

    Fort Wayne 4920423, Indiana 4921868 46804
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Research Site

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Research Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Research Site

    Baltimore 4347778, Maryland 4361885 21231
    United States

    Site Not Available

  • Research Site

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Site Not Available

  • Research Site

    Rockville 4367175, Maryland 4361885 20852
    United States

    Site Not Available

  • Research Site

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Research Site

    Hattiesburg 4429295, Mississippi 4436296 39401
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Research Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Research Site

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Site Not Available

  • Research Site

    Reno, Nevada 89511
    United States

    Site Not Available

  • Research Site

    Reno 5511077, Nevada 5509151 89511
    United States

    Site Not Available

  • Research Site

    Jamaica, New York 11432
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Research Site

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Research Site

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Research Site

    Canton, Ohio 44718
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Research Site

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • Research Site

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Research Site

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Research Site

    York, Pennsylvania 17403
    United States

    Site Not Available

  • Research Site

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Site Not Available

  • Research Site

    York 4562407, Pennsylvania 6254927 17403
    United States

    Site Not Available

  • Research Site

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Research Site

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77090
    United States

    Site Not Available

  • Research Site

    Huntsville, Texas 77340
    United States

    Site Not Available

  • Research Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77090
    United States

    Site Not Available

  • Research Site

    Huntsville 4699540, Texas 4736286 77340
    United States

    Site Not Available

  • Research Site

    Kingwood 7534469, Texas 4736286 77339
    United States

    Site Not Available

  • Research Site

    Lacey, Washington 98503
    United States

    Site Not Available

  • Research Site

    Spokane, Washington 99202
    United States

    Site Not Available

  • Research Site

    Appleton, Wisconsin 54911
    United States

    Site Not Available

  • Research Site

    Appleton 5244080, Wisconsin 5279468 54911
    United States

    Site Not Available

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