A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

Last updated: January 26, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Adenocarcinoma

Treatment

Cisplatin

Rilvegostomig

Etoposide

Clinical Study ID

NCT06564844
D926TC00001
2024-512195-35-00
  • Ages > 18
  • All Genders

Study Summary

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed)adenocarcinoma NSCLC

  2. Complete surgical resection (R0) of the primary NSCLC

  3. Unequivocal no evidence of disease at post-surgical

  4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least onehigh-risk pathological feature (visceral pleural invasion (VPI), lymphovascularinvasion (LVI), high-grade histology) (Stage IB only)

  5. ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery

  6. Adequate bone marrow reserve and organ function

Exclusion

Exclusion Criteria:

  1. Sensitizing EGFR mutation and/or ALK alteration

  2. History of non-infectious ILD/pneumonitis that required steroids, has currentILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out byimaging at screening

  3. Significant pulmonary function compromise

  4. History of another primary malignancy within 3 years (with exceptions)

  5. Any evidence of severe or uncontrolled systemic diseases, including but not limitedto bleeding diseases, active infection and cardiac disease

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

  7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or knownHIV infection that is not well controlled

  8. History of active primary immunodeficiency

  9. Clinically significant corneal disease

Study Design

Total Participants: 24
Treatment Group(s): 8
Primary Treatment: Cisplatin
Phase: 3
Study Start date:
October 15, 2024
Estimated Completion Date:
June 30, 2027

Study Description

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Connect with a study center

  • Research Site

    Camperdown 2172563, 2050
    Australia

    Site Not Available

  • Research Site

    Murdoch 8349091, 6150
    Australia

    Site Not Available

  • Research Site

    Townsville 2146142, 4810
    Australia

    Site Not Available

  • Research Site

    Edegem, 2650
    Belgium

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  • Research Site

    Edegem 2799007, 2650
    Belgium

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  • Research Site

    Hasselt, 3500
    Belgium

    Site Not Available

  • Research Site

    Hasselt 2796491, 3500
    Belgium

    Site Not Available

  • Research Site

    Barretos, 14784-057
    Brazil

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  • Research Site

    Barretos 3470451, 14784-057
    Brazil

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  • Research Site

    Brasília, 70200-730
    Brazil

    Site Not Available

  • Research Site

    Brasília 3469058, 70200-730
    Brazil

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  • Research Site

    Florianópolis, 88034-000
    Brazil

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  • Research Site

    Florianópolis 3463237, 88034-000
    Brazil

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  • Research Site

    Sao Paulo, 01323-903
    Brazil

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  • Research Site

    São Paulo 3448439, 01323-903
    Brazil

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  • Research Site

    Teresina, 64049-200
    Brazil

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  • Research Site

    Teresina 3386496, 64049-200
    Brazil

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    St. John's, Newfoundland and Labrador A1B 3V6
    Canada

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  • Research Site

    St. John's 6324733, Newfoundland and Labrador 6354959 A1B 3V6
    Canada

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  • Research Site

    Halifax, Nova Scotia B3H 2Y9
    Canada

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    Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
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  • Research Site

    Newmarket, Ontario L3Y 2R2
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    Oshawa, Ontario L1G 2B9
    Canada

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  • Research Site

    Newmarket 6087701, Ontario 6093943 L3Y 2R2
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    Oshawa 6094578, Ontario 6093943 L1G 2B9
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    Greenfield Park, Quebec J4V 2H1
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    Montreal, Quebec H2X 3J4
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    Greenfield Park 5966078, Quebec 6115047 J4V 2H1
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    Montreal 6077243, Quebec 6115047 H2X 3J4
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    Saskatoon 6141256, Saskatchewan 6141242 S7M 0Z9
    Canada

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    Angers, 49933
    France

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  • Research Site

    Angers 3037656, 49933
    France

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    Marseille, 13915
    France

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  • Research Site

    Marseille 2995469, 13915
    France

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    Paris 2988507, 75248
    France

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    Paris Cedex 5, 75248
    France

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    Rouen, 76031
    France

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    Rouen 2982652, 76031
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    Suresnes, 92150
    France

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    Suresnes 2973675, 92150
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    Toulon, 83000
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    Toulon 2972328, 83000
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    Bonn, 53127
    Germany

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    Bonn 2946447, 53127
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    Erfurt, 99089
    Germany

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    Erfurt 2929670, 99089
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    Essen, 45239
    Germany

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    Essen 2928810, 45239
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    Esslingen, 73730
    Germany

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    Esslingen am Neckar 2928751, 73730
    Germany

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    Gauting, 82131
    Germany

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    Gauting 2922230, 82131
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    Georgsmarienhütte, 49124
    Germany

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    Georgsmarienhütte 2921242, 49124
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    Gera, 07548
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    Gera 2921232, 07548
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    Giessen, 35392
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    Giessen 2920512, 35392
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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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    Luebeck, 23538
    Germany

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    Lübeck 2875601, 23538
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    Münster, 48163
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    Münster 2867543, 48163
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    Würzburg, 97067
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    Würzburg 2805615, 97067
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    Hong Kong, 999077
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    Hong Kong 1819729, 999077
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    Jordan, HKG
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    Budapest, 1122
    Hungary

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    Budapest 3054643, 1122
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    Debrecen, 4032
    Hungary

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    Debrecen 721472, 4032
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    Deszk 721411, 6772
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    Gyöngyös - Mátraháza, 3200
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    Pécs, 7624
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    Pécs 3046526, 7624
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    Törökbálint, 2045
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    Törökbálint 3043778, 2045
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    Zalaegerszeg, 8000
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    Zalaegerszeg 3042638, 8000
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    Firenze, 50134
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    Florence 3176959, 50134
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    Monza, 20090
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    Monza 3172629, 20090
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    Padova, 35128
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    Padua 3171728, 35128
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    Roma, 00144
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    Roma 8957247, 00168
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    Rozzano, 20089
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    Rozzano 3168837, 20089
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    Bunkyo-ku, 113-8603
    Japan

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    Bunkyō City 11790632, 113-8603
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    Chiba 2113015, 260-0877
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    Chiba-shi, 260-0877
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    Chuo-ku, 104-0045
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    Chūōku 10262791, 104-0045
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    Fukuoka 1863967, 812-8582
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    Fukuoka-shi, 812-8582
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    Hidaka-shi, 350-1298
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    Hiroshima 1862415, 734-8551
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    Hiroshima-shi, 730-8518
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    Iwakuni-shi, 740-8510
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    Kashiwa, 277-8577
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    Kashiwa 1859924, 277-8577
    Japan

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    Kitaadachi-gun, 362-0806
    Japan

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  • Research Site

    Kobe 1859171, 650-0017
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    Kobe-shi, 650-0017
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    Koto-ku, 135-8550
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    Kumamoto 1858421, 860-8556
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    Kumamoto-shi, 860-8556
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    Kōtoku 2128852, 135-8550
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    Nagoya 1856057, 464-8681
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    Nagoya-shi, 464-8681
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    Niigata 1855431, 951-8566
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    Niigata-shi, 951-8566
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    Osakasayama-shi, 589-8511
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    Sapporo 2128295, 003-0804
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    Sapporo-shi, 003-0804
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    Sendai 2111149, 980-8574
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    Sendai-shi, 980-8574
    Japan

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    Wakayama 1926004, 641-8510
    Japan

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    Wakayama-shi, 641-8510
    Japan

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    Yokohama 1848354, 241-8515
    Japan

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    Yokohama-shi, 241-8515
    Japan

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    Incheon, 21565
    Korea, Republic of

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    Seoul, 03722
    Korea, Republic of

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    Suwon, 16247
    Korea, Republic of

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    George Town, 10450
    Malaysia

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    George Town 1735106, 10450
    Malaysia

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    Kuala Lumpur, 59100
    Malaysia

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    Kuala Lumpur 1735161, 59100
    Malaysia

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    Kuala Selangor 1732891, 62250
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    Kuching, 93586
    Malaysia

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    Kuching 1735634, 93586
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    Selangor, 62250
    Malaysia

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    Rotterdam, 3015 GD
    Netherlands

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    Rotterdam 2747891, 3015 GD
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    Olsztyn, 10-357
    Poland

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    Olsztyn 763166, 10-357
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    Poznan 3088171, 60-569
    Poland

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    Poznań, 60-569
    Poland

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    Warsaw 756135, 01-138
    Poland

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    Warszawa, 01-138
    Poland

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  • Research Site

    Incheon 1843564, 21565
    South Korea

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    Seoul 1835848, 03722
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    Suwon 1835553, 16247
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    Alicante, 03010
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    Alicante 2521978, 03010
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    Badalona, 08003
    Spain

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    Badalona 3129028, 08003
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    Barcelona, 8035
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    Barcelona 3128760, 8035
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    Madrid, 28040
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    Madrid 3117735, 28040
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    Malaga, 29004
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    Málaga 2514256, 29004
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    Zaragoza, 50009
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    Zaragoza 3104324, 50009
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    Solna, 171 76
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    Solna 2675397, 171 76
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    Zurich, 8091
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    Zurich 2657896, 8091
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    Kaohsiung, 80756
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    Kaohsiung City 1673820, 80756
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    Taipei, 114
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    Taipei 1668341, 114
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    Taoyuan, 333
    Taiwan

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    Taoyuan District 1667905, 333
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    Bangkok, 10400
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    Bangkok 1609350, 10400
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    Bangkoknoi, 10700
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    Banphaeo, 74120
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    Dusit, 10300
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    Dusit 1610858, 10300
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    Hat Yai, 90110
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    Hat Yai 1610780, 90110
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    Muang, 50200
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    Ratchathewi, 10400
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    Ratchathewi 7026885, 10400
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    Ankara, 06010
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    Istanbul, 34214
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    Mersin, 33240
    Turkey

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    Ankara 323786, 06010
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    Istanbul 745044, 34214
    Turkey (Türkiye)

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    Mersin 304531, 33240
    Turkey (Türkiye)

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    Leeds, LS9 7TF
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    Leeds 2644688, LS9 7TF
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    London, SE1 9RT
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    London 2643743, SE1 9RT
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    Nottingham, NG5 1PB
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    Nottingham 2641170, NG5 1PB
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    Gilbert, Arizona 85234
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    Phoenix, Arizona 85054
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    Prescott, Arizona 86301
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    Tucson, Arizona 85719
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    Gilbert 5295903, Arizona 5551752 85234
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    Phoenix 5308655, Arizona 5551752 85054
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    Prescott 5309842, Arizona 5551752 86301
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    Glendale, California 91204
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    Los Angeles, California 90089
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    Newport Beach, California 92663
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    Orange, California 92868
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    San Diego, California 92123
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    Santa Barbara, California 93105
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    Duarte 5344147, California 5332921 91010
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    Fountain Valley 5350207, California 5332921 92708
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    Glendale 5352423, California 5332921 91204
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    Irvine 5359777, California 5332921 92612
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    San Diego 5391811, California 5332921 92123
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    Santa Barbara 5392952, California 5332921 93105
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    Aurora, Colorado 80045
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    Lone Tree, Colorado 80124
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    Aurora 5412347, Colorado 5417618 80045
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    Lone Tree 5429208, Colorado 5417618 80124
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    Newark, Delaware 19713
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    Newark 4143861, Delaware 4142224 19713
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    Washington, District of Columbia 20010
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    Washington D.C. 4140963, District of Columbia 4138106 20007
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    Clermont, Florida 34711
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    Fort Myers, Florida 33901
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    Jacksonville, Florida 32224
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    Miami, Florida 33136
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    Miami Beach, Florida 33140
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    Orange City, Florida 32763
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    Orlando, Florida 32803
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    Saint Petersburg, Florida 33705
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    Clermont 4151352, Florida 4155751 34711
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    Fort Myers 4155995, Florida 4155751 33901
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    Jacksonville 4160021, Florida 4155751 32224
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    Boise, Idaho 83702
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    Chicago, Illinois 60637
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    Evanston, Illinois 60201
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    Zion, Illinois 60099
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    Chicago 4887398, Illinois 4896861 60637
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    Evanston 4891382, Illinois 4896861 60201
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    Zion 4917358, Illinois 4896861 60099
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    Dyer, Indiana 46311
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    United States

    Site Not Available

  • Research Site

    Fort Wayne 4920423, Indiana 4921868 46804
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Research Site

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Research Site

    Lexington 4297983, Kentucky 6254925 40503
    United States

    Site Not Available

  • Research Site

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Research Site

    Frederick, Maryland 21702
    United States

    Site Not Available

  • Research Site

    Silver Spring, Maryland 20902
    United States

    Site Not Available

  • Research Site

    Annapolis 4347242, Maryland 4361885 21401
    United States

    Site Not Available

  • Research Site

    Baltimore 4347778, Maryland 4361885 21237
    United States

    Site Not Available

  • Research Site

    Frederick 4355585, Maryland 4361885 21702
    United States

    Site Not Available

  • Research Site

    Silver Spring 4369596, Maryland 4361885 20910
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Research Site

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Research Site

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Research Site

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Research Site

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Site

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Research Site

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Research Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Research Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Research Site

    Dearborn 4990510, Michigan 5001836 48126
    United States

    Site Not Available

  • Research Site

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Research Site

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • Research Site

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • Research Site

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Site Not Available

  • Research Site

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Research Site

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Research Site

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Research Site

    Duluth 5024719, Minnesota 5037779 55805
    United States

    Site Not Available

  • Research Site

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Site Not Available

  • Research Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis 4407066, Missouri 4398678 63108
    United States

    Site Not Available

  • Research Site

    Billings, Montana 59102
    United States

    Site Not Available

  • Research Site

    Billings 5640350, Montana 5667009 59102
    United States

    Site Not Available

  • Research Site

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Research Site

    Omaha 5074472, Nebraska 5073708 68130
    United States

    Site Not Available

  • Research Site

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Research Site

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • Research Site

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Research Site

    Camden 4501018, New Jersey 5101760 08103
    United States

    Site Not Available

  • Research Site

    Bronx, New York 10467
    United States

    Site Not Available

  • Research Site

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Research Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    White Plains, New York 10601
    United States

    Site Not Available

  • Research Site

    East Syracuse 5116079, New York 5128638 13057
    United States

    Site Not Available

  • Research Site

    Mineola 5127134, New York 5128638 11501
    United States

    Site Not Available

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Research Site

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • Research Site

    White Plains 5144336, New York 5128638 10601
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Research Site

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44124
    United States

    Site Not Available

  • Research Site

    Independence, Ohio 44131
    United States

    Site Not Available

  • Research Site

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Research Site

    Cleveland 5150529, Ohio 5165418 44124
    United States

    Site Not Available

  • Research Site

    Independence 5158404, Ohio 5165418 44131
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97213
    United States

    Site Not Available

  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Research Site

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Research Site

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Research Site

    Bethlehem 5180225, Pennsylvania 6254927 18015
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Research Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Research Site

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Research Site

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Site Not Available

  • Research Site

    Memphis 4641239, Tennessee 4662168 38120
    United States

    Site Not Available

  • Research Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78745
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78217
    United States

    Site Not Available

  • Research Site

    Webster, Texas 77598
    United States

    Site Not Available

  • Research Site

    Austin 4671654, Texas 4736286 78745
    United States

    Site Not Available

  • Research Site

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78217
    United States

    Site Not Available

  • Research Site

    Webster 4740423, Texas 4736286 77598
    United States

    Site Not Available

  • Research Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Research Site

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • Research Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Research Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Research Site

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Research Site

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98104
    United States

    Site Not Available

  • Research Site

    Silverdale, Washington 98383
    United States

    Site Not Available

  • Research Site

    Vancouver, Washington 98684
    United States

    Site Not Available

  • Research Site

    Edmonds 5793427, Washington 5815135 98026
    United States

    Site Not Available

  • Research Site

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

  • Research Site

    Silverdale 5810490, Washington 5815135 98383
    United States

    Site Not Available

  • Research Site

    Vancouver 5814616, Washington 5815135 98684
    United States

    Site Not Available

  • Research Site

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Research Site

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

  • Research Site

    Da Nang, 550000
    Vietnam

    Site Not Available

  • Research Site

    Da Nang 1583992, 550000
    Vietnam

    Site Not Available

  • Research Site

    Ha noi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi 1581130, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City 1566083, 700000
    Vietnam

    Site Not Available

  • Research Site

    Hà Nội 8564175, 100000
    Vietnam

    Site Not Available

  • Research Site

    Vinh, 460000
    Vietnam

    Site Not Available

  • Research Site

    Vinh 1562798, 460000
    Vietnam

    Site Not Available

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