Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.

Study Overview

• Status: Terminated
• Conditions: Cancer; Anemia; Non-Small Cell Lung Cancer; Lung Cancer
• Intervention / Treatment: Drug: Placebo; Drug: Darbepoetin alfa

Detailed Description

Oversight Authorities continued: Colombia

• Study Type: Interventional
• Enrollment (Actual): 2549
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1180AAX
    • Research Site
  • La Rioja, Argentina, F5300COE
    • Research Site
  • Santa Fe, Argentina, S3000FFU
    • Research Site
  • Buenos Aires
    • Quilmes, Buenos Aires, Argentina, B1878GEG
      • Research Site
    • Quilmes, Buenos Aires, Argentina, B1878DVB
      • Research Site
  • Córdoba
    • Cordoba, Córdoba, Argentina, X5006HBF
      • Research Site
  • Distrito Federal
    • Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1019ABS
      • Research Site
    • Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1185AAT
      • Research Site
  • Jujuy
    • San Salvador de Jujuy, Jujuy, Argentina, 4600
      • Research Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000CVD
      • Research Site
    • Rosario, Santa Fe, Argentina, S2002KDS
      • Research Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000GTB
      • Research Site
• Austria
  • Steyr, Austria, 4400
    • Research Site
  • Wien, Austria, 1090
    • Research Site
• Belgium
  • Ieper, Belgium, 8900
    • Research Site
  • Libramont, Belgium, 6800
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
  • Namur, Belgium, 5000
    • Research Site
  • Ottignies, Belgium, 1340
    • Research Site
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Research Site
  • Rio de Janeiro, Brazil, 22640-000
    • Research Site
  • Rio de Janeiro, Brazil, 22260-020
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Research Site
  • Bahia
    • Salvador, Bahia, Brazil, 40170-110
      • Research Site
  • Ceará
    • Fortaleza, Ceará, Brazil, 60336-045
      • Research Site
    • Fortaleza, Ceará, Brazil, 60430-230
      • Research Site
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 72110-150
      • Research Site
  • Espírito Santo
    • Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-020
      • Research Site
  • Mato Grosso Do Sul
    • Campo Grande, Mato Grosso Do Sul, Brazil, 79010-050
      • Research Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-090
      • Research Site
    • Belo Horizonte, Minas Gerais, Brazil, 30150-281
      • Research Site
    • Belo Horizonte, Minas Gerais, Brazil, 30150-321
      • Research Site
    • Belo Horizonte, Minas Gerais, Brazil, 30285-000
      • Research Site
  • Paraná
    • Curitba, Paraná, Brazil, 81520-060
      • Research Site
    • Curitiba, Paraná, Brazil, 80010-030
      • Research Site
    • Curitiba, Paraná, Brazil, 80530-010
      • Research Site
    • Londrina, Paraná, Brazil, 86050-190
      • Research Site
  • Pará
    • Belem, Pará, Brazil, 66053-000
      • Research Site
  • Rio Grande Do Sul
    • Ijui, Rio Grande Do Sul, Brazil, 98700-000
      • Research Site
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
      • Research Site
    • Pelotas, Rio Grande Do Sul, Brazil, 96015-280
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440
      • Research Site
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • Research Site
  • São Paulo
    • Ribeirao Preto, São Paulo, Brazil, 14015-130
      • Research Site
    • Santo Andre, São Paulo, Brazil, 09060-650
      • Research Site
    • Santo Andre, São Paulo, Brazil, 09090-780
      • Research Site
    • Sao Jose dos Campos, São Paulo, Brazil, 12245-750
      • Research Site
    • Sao Paulo, São Paulo, Brazil, 01221-020
      • Research Site
    • Sao Paulo, São Paulo, Brazil, 08270-070
      • Research Site
• Bulgaria
  • Ruse, Bulgaria, 7002
    • Research Site
  • Sofia, Bulgaria, 1784
    • Research Site
  • Sofia, Bulgaria, 1233
    • Research Site
  • Varna, Bulgaria, 9000
    • Research Site
• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Research Site
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Research Site
    • Toronto, Ontario, Canada, M9N 1N8
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
      • Research Site
    • Saint-Jerome, Quebec, Canada, J7Z 5T3
      • Research Site
• Chile
  • Santiago, Chile, 8380455
    • Research Site
  • Santiago, Chile, 7500006
    • Research Site
  • Santiago, Chile, 7571831
    • Research Site
  • Cautín
    • Temuco, Cautín, Chile, 4810469
      • Research Site
  • Valparaíso
    • Renaca, Valparaíso, Chile
      • Research Site
• China
  • Beijing, China, 100142
    • Research Site
  • Beijing, China, 100020
    • Research Site
  • Beijing, China, 100021
    • Research Site
  • Beijing, China, 101149
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Chongqing, China, 400030
    • Research Site
  • Chongqing, China, 400037
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 200092
    • Research Site
  • Shanghai, China, 200127
    • Research Site
  • Shanghai, China, 200003
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  • Beijing
    • Beijing, Beijing, China, 100191
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  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Research Site
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Research Site
    • Fuzhou, Fujian, China, 350025
      • Research Site
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Research Site
    • Guangzhou, Guangdong, China, 510120
      • Research Site
    • Guangzhou, Guangdong, China, 510010
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    • Zhongshan, Guangdong, China, 528403
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  • Hainan
    • Haikou, Hainan, China, 570102
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    • Haikou, Hainan, China, 570311
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  • Hebei
    • Shijiazhuang, Hebei, China, 050011
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  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
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  • Hubei
    • Wuhan, Hubei, China, 430030
      • Research Site
    • Wuhan, Hubei, China, 430070
      • Research Site
  • Hunan
    • Changsha, Hunan, China, 410013
      • Research Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Research Site
    • Nanjing, Jiangsu, China, 210002
      • Research Site
    • Suzhou, Jiangsu, China, 215004
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  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
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  • Jilin
    • Changchun, Jilin, China, 130021
      • Research Site
    • Changchun, Jilin, China, 130012
      • Research Site
  • Liaoning
    • Dalian, Liaoning, China, 116027
      • Research Site
    • Shenyang, Liaoning, China, 110016
      • Research Site
    • Shenyang, Liaoning, China, 110042
      • Research Site
  • Shaanxi
    • XI An, Shaanxi, China, 710038
      • Research Site
  • Shandong
    • Jinan, Shandong, China, 250013
      • Research Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Research Site
    • Chengdu, Sichuan, China, 610072
      • Research Site
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • Research Site
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Research Site
    • Kunming, Yunnan, China, 650118
      • Research Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Research Site
    • Hangzhou, Zhejiang, China, 310016
      • Research Site
    • Hangzhou, Zhejiang, China, 310022
      • Research Site
• Croatia
  • Rijeka, Croatia, 51000
    • Research Site
  • Zagreb, Croatia, 10000
    • Research Site
• Czechia
  • Benesov U Prahy, Czechia, 256 30
    • Research Site
  • Horovice, Czechia, 268 31
    • Research Site
  • Kutna Hora, Czechia, 284 01
    • Research Site
  • Kyjov, Czechia, 697 33
    • Research Site
  • Nova Ves pod Plesi, Czechia, 262 04
    • Research Site
  • Ostrava-Poruba, Czechia, 708 52
    • Research Site
  • Praha 4, Czechia, 140 59
    • Research Site
  • Praha 8, Czechia, 180 81
    • Research Site
  • Pribram, Czechia, 261 01
    • Research Site
• Germany
  • Bad Berka, Germany, 99437
    • Research Site
  • Köln-Merheim, Germany, 51109
    • Research Site
  • Moers, Germany, 47441
    • Research Site
  • München, Germany, 80336
    • Research Site
  • Münster, Germany, 48149
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 14564
    • Research Site
  • Athens, Greece, 12462
    • Research Site
  • Chania, Greece, 73300
    • Research Site
  • Larissa, Greece, 41110
    • Research Site
  • Nea Kifissia, Athens, Greece, 14564
    • Research Site
  • Piraeus, Greece, 18537
    • Research Site
  • Thessaloniki, Greece, 57010
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
  • Kowloon, Hong Kong
    • Research Site
  • New Territories, Hong Kong
    • Research Site
• India
  • Bangalore, India, 560 029
    • Research Site
  • Delhi
    • New Delhi, Delhi, India, 110 030
      • Research Site
  • Goa
    • Panaji, Goa, India, 403 001
      • Research Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 009
      • Research Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 054
      • Research Site
    • Mangalore, Karnataka, India, 575 001
      • Research Site
  • Kerala
    • Kochi, Kerala, India, 682 304
      • Research Site
  • Madhya Pradesh
    • Bhopal, Madhya Pradesh, India, 462 001
      • Research Site
  • Maharashtra
    • Ahmednagar, Maharashtra, India, 413 736
      • Research Site
    • Aurangabad, Maharashtra, India, 431 001
      • Research Site
    • Thane, Maharashtra, India, 400 607
      • Research Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302 013
      • Research Site
    • Jaipur, Rajasthan, India, 302 004
      • Research Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 018
      • Research Site
    • Madurai, Tamil Nadu, India, 625 107
      • Research Site
  • West Bengal
    • Kolkata, West Bengal, India, 700 026
      • Research Site
• Ireland
  • Dublin, Ireland, 8
    • Research Site
  • Dublin, Ireland, 24
    • Research Site
• Israel
  • Jerusalem, Israel, 91120
    • Research Site
  • Kefar Saba, Israel, 44281
    • Research Site
  • Poria Eylit, Israel, 15208
    • Research Site
  • Rehovot, Israel, 76100
    • Research Site
  • Tel Aviv, Israel, 64239
    • Research Site
• Italy
  • Catania, Italy, 95122
    • Research Site
  • Faenza RA, Italy, 48018
    • Research Site
  • Grosseto, Italy, 58100
    • Research Site
  • Lecce, Italy, 73100
    • Research Site
  • Legnago VR, Italy, 37045
    • Research Site
  • Lugo RA, Italy, 48022
    • Research Site
  • Meldola FC, Italy, 47014
    • Research Site
  • Messina, Italy, 98125
    • Research Site
  • Milano, Italy, 20142
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Ravenna, Italy, 48100
    • Research Site
  • Reggio Calabria, Italy, 89124
    • Research Site
  • San Giovanni Rotondo FG, Italy, 71013
    • Research Site
• Japan
  • Kyoto, Japan, 615-8256
    • Research Site
  • Aichi
    • Nagoya-shi, Aichi, Japan, 460-0001
      • Research Site
  • Fukui
    • Fukui-Shi, Fukui, Japan, 910-8526
      • Research Site
  • Fukuoka
    • Chikushino-shi, Fukuoka, Japan, 818-8516
      • Research Site
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Research Site
  • Hyogo
    • Amagasaki-shi, Hyogo, Japan, 660-8550
      • Research Site
    • Kobe, Hyogo, Japan, 650-0047
      • Research Site
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Research Site
    • Nishinomiya-shi, Hyogo, Japan, 663-8501
      • Research Site
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Research Site
  • Kanagawa
    • Sagamihara-shi, Kanagawa, Japan, 252-0375
      • Research Site
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8607
      • Research Site
  • Osaka
    • Osaka-shi, Osaka, Japan, 541-8567
      • Research Site
    • Osaka-shi, Osaka, Japan, 545-8586
      • Research Site
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Research Site
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Research Site
  • Tottori
    • Yonago-shi, Tottori, Japan, 683-8504
      • Research Site
• Korea, Republic of
  • Gwangju, Korea, Republic of, 519-763
    • Research Site
  • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
    • Research Site
  • Seoul, Korea, Republic of, 136-705
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• Luxembourg
  • Esch-Sur-Alzette, Luxembourg, 4005
    • Research Site
  • Luxembourg, Luxembourg, 1210
    • Research Site
• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Research Site
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Research Site
  • Pinang
    • Georgetown, Pinang, Malaysia, 10050
      • Research Site
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88996
      • Research Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
      • Research Site
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
      • Research Site
• Mexico
  • Chihuahua, Mexico, 31217
    • Research Site
  • Colima, Mexico, 28030
    • Research Site
  • Oaxaca, Mexico, 68000
    • Research Site
  • Puebla, Mexico, 72270
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  • Coahuila
    • Saltillo, Coahuila, Mexico, 25000
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  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06100
      • Research Site
    • Mexico, Distrito Federal, Mexico, 06720
      • Research Site
    • Mexico, Distrito Federal, Mexico, 07300
      • Research Site
    • Mexico City, Distrito Federal, Mexico, 14080
      • Research Site
    • Mexico City, Distrito Federal, Mexico, 06720
      • Research Site
    • Mexico City, Distrito Federal, Mexico, 14140
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  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Research Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Research Site
    • Zapopan, Jalisco, Mexico, 45200
      • Research Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • Research Site
  • Querétaro
    • Queretaro, Querétaro, Mexico, 76090
      • Research Site
  • San Luis Potosí
    • San Luis Potosi, San Luis Potosí, Mexico, 78216
      • Research Site
  • Yucatán
    • Merida, Yucatán, Mexico, 97000
      • Research Site
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Research Site
  • Eindhoven, Netherlands, 5623 EJ
    • Research Site
  • Rotterdam, Netherlands, 3015 CE
    • Research Site
  • Tilburg, Netherlands, 5022 GC
    • Research Site
• Philippines
  • Davao
    • Davao City, Davao, Philippines, 8000
      • Research Site
• Poland
  • Krakow, Poland, 31-501
    • Research Site
  • Olsztyn, Poland, 10-357
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  • Olsztyn, Poland, 10-228
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  • Rzeszow, Poland, 35-055
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• Puerto Rico
  • San Juan, Puerto Rico, 00927
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  • San Juan, Puerto Rico, 00910
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• Romania
  • Sibiu, Romania, 550245
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• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Research Site
  • Barnaul, Russian Federation, 656049
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  • Belgorod, Russian Federation, 308010
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  • Ivanovo, Russian Federation, 153013
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  • Kirov, Russian Federation, 610021
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  • Krasnodar, Russian Federation, 350000
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  • Kursk, Russian Federation, 305035
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  • Lipetsk, Russian Federation, 398005
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  • Moscow, Russian Federation, 115478
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  • Nizhniy Novgorod, Russian Federation, 603081
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  • Novosibirsk, Russian Federation, 630047
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  • Obninsk, Russian Federation, 249036
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  • Omsk, Russian Federation, 644013
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  • Orenburg, Russian Federation, 460021
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  • Penza, Russian Federation, 440071
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  • Pyatigorsk, Russian Federation, 357502
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  • Saint-Petersburg, Russian Federation, 197101
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  • Samara, Russian Federation, 443031
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  • Saratov, Russian Federation, 410004
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  • Stavropol, Russian Federation, 355047
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  • Tula, Russian Federation, 300040
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  • Tver, Russian Federation, 170008
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  • Ufa, Russian Federation, 450054
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  • Ulyanovsk, Russian Federation, 432063
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  • Voronezh, Russian Federation, 394000
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  • Yaroslavl, Russian Federation, 150040
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• Serbia
  • Belgrade, Serbia, 11129
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  • Gornji Matejevac, Serbia, 18204
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  • Kragujevac, Serbia, 34000
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  • Sremska Kamenica, Serbia, 21204
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• Slovenia
  • Golnik, Slovenia, 4204
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  • Pohorje, Slovenia, 2208
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• South Africa
  • Bloemfontein, South Africa, 9301
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  • Johannesburg, South Africa, 1501
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  • Overport, South Africa, 4091
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  • Polokwane, South Africa, 0699
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  • KwaZulu-Natal
    • Umhlanga, KwaZulu-Natal, South Africa, 4320
      • Research Site
• Spain
  • Andalucía
    • Granada, Andalucía, Spain, 18014
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  • Canarias
    • Las Palmas de Gran Canaria, Canarias, Spain, 35016
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  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
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  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
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    • Benidorm, Comunidad Valenciana, Spain, 03501
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    • Valencia, Comunidad Valenciana, Spain, 46017
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  • Galicia
    • Pontevedra, Galicia, Spain, 36001
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• Switzerland
  • Aarau, Switzerland, 5001
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  • Aarau, Switzerland, 5000
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  • Chur, Switzerland, 7000
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  • Sursee, Switzerland, 6210
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  • Zurich, Switzerland, 8063
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• Taiwan
  • Kaohsiung, Taiwan, 81362
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  • Taichung, Taiwan, 40705
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• Ukraine
  • Kirovograd, Ukraine, 25011
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• United Kingdom
  • Bebington, United Kingdom, CH63 4JY
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  • Dorechester, United Kingdom, DT1 2JY
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  • Dorset, United Kingdom, BH15 2JB
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  • Liverpool, United Kingdom, L14 3PE
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  • Manchester, United Kingdom, M20 4BX
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• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
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    • Birmingham, Alabama, United States, 35216
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  • Alaska
    • Anchorage, Alaska, United States, 99508
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  • Arizona
    • Tucson, Arizona, United States, 85704
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  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
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    • Hot Springs, Arkansas, United States, 71913
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    • Jonesboro, Arkansas, United States, 72401
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    • Little Rock, Arkansas, United States, 72205
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  • California
    • Anaheim, California, United States, 92801
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    • Arcadia, California, United States, 91007
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    • Berkeley, California, United States, 94704
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    • Burbank, California, United States, 91505
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    • Fountain Valley, California, United States, 92708
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    • Fresno, California, United States, 93720
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    • Fresno, California, United States, 93703
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    • La Verne, California, United States, 91750
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    • Lancaster, California, United States, 93534
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    • Long Beach, California, United States, 90822
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    • Los Angeles, California, United States, 90027
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    • Los Angeles, California, United States, 90048
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    • Los Angeles, California, United States, 90024
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    • Merced, California, United States, 95348
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    • Mission Hills, California, United States, 91345
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    • Montebello, California, United States, 90640
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    • Oxnard, California, United States, 93030
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    • Palm Springs, California, United States, 92262
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    • Pismo Beach, California, United States, 93449
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    • Pomona, California, United States, 91767
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    • Redlands, California, United States, 92374
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    • Saint Helena, California, United States, 94574
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    • Salinas, California, United States, 93901
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    • San Diego, California, United States, 92161
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    • Santa Rosa, California, United States, 95403
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    • Simi Valley, California, United States, 93065
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    • Soquel, California, United States, 95073
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    • Torrance, California, United States, 90501
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    • Vallejo, California, United States, 94589
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    • West Covina, California, United States, 91790
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  • Colorado
    • Denver, Colorado, United States, 80218
      • Research Site
    • Denver, Colorado, United States, 80210
      • Research Site
    • Englewood, Colorado, United States, 80113
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  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Research Site
    • Southington, Connecticut, United States, 06489
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Research Site
    • Washington, District of Columbia, United States, 20060
      • Research Site
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Research Site
    • Boynton Beach, Florida, United States, 33435
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    • Coral Springs, Florida, United States, 33065
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    • Daytona Beach, Florida, United States, 32114
      • Research Site
    • Fort Lauderdale, Florida, United States, 33316
      • Research Site
    • Holiday, Florida, United States, 34691
      • Research Site
    • Hollywood, Florida, United States, 33021
      • Research Site
    • Jacksonville, Florida, United States, 32256
      • Research Site
    • Kissimmee, Florida, United States, 34741
      • Research Site
    • Lake Worth, Florida, United States, 33461
      • Research Site
    • Lakeland, Florida, United States, 33805
      • Research Site
    • Lecanto, Florida, United States, 34461
      • Research Site
    • Miami, Florida, United States, 33133
      • Research Site
    • New Port Richey, Florida, United States, 34652
      • Research Site
    • New Port Richey, Florida, United States, 34655
      • Research Site
    • Orange City, Florida, United States, 32763
      • Research Site
    • Orlando, Florida, United States, 32806
      • Research Site
    • Pembroke Pines, Florida, United States, 33029
      • Research Site
    • Rockledge, Florida, United States, 32955
      • Research Site
    • Tamarac, Florida, United States, 33321
      • Research Site
    • The Villages, Florida, United States, 32159
      • Research Site
    • Titusville, Florida, United States, 32796
      • Research Site
    • Weston, Florida, United States, 33331
      • Research Site
  • Georgia
    • Albany, Georgia, United States, 31701
      • Research Site
    • Augusta, Georgia, United States, 30901
      • Research Site
    • Stockbridge, Georgia, United States, 30281
      • Research Site
    • Thomasville, Georgia, United States, 31792
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Research Site
    • Chicago, Illinois, United States, 60616
      • Research Site
    • Galesburg, Illinois, United States, 61401
      • Research Site
    • Gurnee, Illinois, United States, 60031
      • Research Site
    • Mount Vernon, Illinois, United States, 62864
      • Research Site
    • Skokie, Illinois, United States, 60077
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46219
      • Research Site
    • Michigan City, Indiana, United States, 46360
      • Research Site
    • Muncie, Indiana, United States, 47303
      • Research Site
  • Iowa
    • Council Bluffs, Iowa, United States, 51503
      • Research Site
    • Dubuque, Iowa, United States, 52001
      • Research Site
    • Iowa City, Iowa, United States, 52242
      • Research Site
    • Sioux City, Iowa, United States, 51101
      • Research Site
    • Waterloo, Iowa, United States, 50702
      • Research Site
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Research Site
    • Wichita, Kansas, United States, 67214
      • Research Site
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Research Site
    • Hazard, Kentucky, United States, 41701
      • Research Site
    • Louisville, Kentucky, United States, 40202
      • Research Site
    • Louisville, Kentucky, United States, 40207
      • Research Site
    • Morehead, Kentucky, United States, 40351
      • Research Site
    • Mount Sterling, Kentucky, United States, 40353
      • Research Site
    • Paducah, Kentucky, United States, 42003
      • Research Site
    • Paducah, Kentucky, United States, 42001
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Research Site
    • Lafayette, Louisiana, United States, 70503
      • Research Site
    • Marrero, Louisiana, United States, 70072
      • Research Site
    • New Orleans, Louisiana, United States, 70112
      • Research Site
    • Ruston, Louisiana, United States, 71270
      • Research Site
    • Shreveport, Louisiana, United States, 71103
      • Research Site
  • Maine
    • Lewiston, Maine, United States, 04240
      • Research Site
    • Rockport, Maine, United States, 04856
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Research Site
    • Baltimore, Maryland, United States, 21215
      • Research Site
    • Baltimore, Maryland, United States, 21218
      • Research Site
    • Bethesda, Maryland, United States, 20817
      • Research Site
    • Chevy Chase, Maryland, United States, 20815
      • Research Site
    • Cumberland, Maryland, United States, 21502
      • Research Site
    • Frederick, Maryland, United States, 21701
      • Research Site
    • Hagerstown, Maryland, United States, 21742
      • Research Site
    • Towson, Maryland, United States, 21204
      • Research Site
    • Westminster, Maryland, United States, 21157
      • Research Site
  • Massachusetts
    • Attleboro, Massachusetts, United States, 02703
      • Research Site
    • Boston, Massachusetts, United States, 02135
      • Research Site
    • Boston, Massachusetts, United States, 02130
      • Research Site
    • Brockton, Massachusetts, United States, 02302
      • Research Site
    • Cambridge, Massachusetts, United States, 02138
      • Research Site
    • Worcester, Massachusetts, United States, 01608
      • Research Site
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Research Site
    • Grand Rapids, Michigan, United States, 49503
      • Research Site
    • Kalamazoo, Michigan, United States, 49048
      • Research Site
    • Southfield, Michigan, United States, 48075
      • Research Site
    • Southgate, Michigan, United States, 48195
      • Research Site
  • Minnesota
    • Willmar, Minnesota, United States, 56201
      • Research Site
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Research Site
    • Hattiesburg, Mississippi, United States, 39401
      • Research Site
    • Jackson, Mississippi, United States, 39216
      • Research Site
    • Tupelo, Mississippi, United States, 38801
      • Research Site
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Research Site
    • Jefferson City, Missouri, United States, 65101
      • Research Site
    • Kansas City, Missouri, United States, 64111
      • Research Site
    • Kansas City, Missouri, United States, 64132
      • Research Site
    • Saint Louis, Missouri, United States, 63110
      • Research Site
    • Saint Louis, Missouri, United States, 63136
      • Research Site
    • Springfield, Missouri, United States, 65807
      • Research Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • Research Site
    • Kalispell, Montana, United States, 59901
      • Research Site
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Research Site
    • Omaha, Nebraska, United States, 68106
      • Research Site
    • Omaha, Nebraska, United States, 68105
      • Research Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Research Site
    • North Las Vegas, Nevada, United States, 89086
      • Research Site
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Research Site
  • New Jersey
    • Sparta, New Jersey, United States, 07871
      • Research Site
    • Teaneck, New Jersey, United States, 07666
      • Research Site
    • Vineland, New Jersey, United States, 08360
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109-4397
      • Research Site
    • Santa Fe, New Mexico, United States, 87505
      • Research Site
  • New York
    • Albany, New York, United States, 12208
      • Research Site
    • Brooklyn, New York, United States, 11212
      • Research Site
    • Buffalo, New York, United States, 14215
      • Research Site
    • Glens Falls, New York, United States, 12801
      • Research Site
    • Goshen, New York, United States, 10924
      • Research Site
    • Lake Success, New York, United States, 11042
      • Research Site
    • Latham, New York, United States, 12110-0610
      • Research Site
    • Nyack, New York, United States, 10960
      • Research Site
    • Poughkeepsie, New York, United States, 12601
      • Research Site
    • Staten Island, New York, United States, 10310
      • Research Site
    • Staten Island, New York, United States, 10301
      • Research Site
    • Syracuse, New York, United States, 13210
      • Research Site
    • Valhalla, New York, United States, 10595
      • Research Site
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Research Site
    • Asheville, North Carolina, United States, 28801
      • Research Site
    • Burlington, North Carolina, United States, 27215
      • Research Site
    • Concord, North Carolina, United States, 28025
      • Research Site
    • Durham, North Carolina, United States, 27704
      • Research Site
    • Goldsboro, North Carolina, United States, 27534
      • Research Site
    • Greenville, North Carolina, United States, 27834
      • Research Site
    • Hendersonville, North Carolina, United States, 28791
      • Research Site
    • Hickory, North Carolina, United States, 28602
      • Research Site
    • High Point, North Carolina, United States, 27262
      • Research Site
    • Huntersville, North Carolina, United States, 28078
      • Research Site
    • Kinston, North Carolina, United States, 28501
      • Research Site
    • Pinehurst, North Carolina, United States, 28374
      • Research Site
    • Raleigh, North Carolina, United States, 27607
      • Research Site
    • Washington, North Carolina, United States, 27889
      • Research Site
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Research Site
  • Ohio
    • Akron, Ohio, United States, 44304
      • Research Site
    • Columbus, Ohio, United States, 43235
      • Research Site
    • Dayton, Ohio, United States, 45428
      • Research Site
    • Massillon, Ohio, United States, 44646
      • Research Site
    • Middletown, Ohio, United States, 45042
      • Research Site
    • Port Clinton, Ohio, United States, 43452
      • Research Site
    • Sylvania, Ohio, United States, 43560
      • Research Site
    • Wooster, Ohio, United States, 44691
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Research Site
    • Tulsa, Oklahoma, United States, 74104
      • Research Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Research Site
    • Gettysburg, Pennsylvania, United States, 17325
      • Research Site
    • Langhorne, Pennsylvania, United States, 19047
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19106
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19102
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19141
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15240
      • Research Site
    • Upland, Pennsylvania, United States, 19013
      • Research Site
    • Willow Grove, Pennsylvania, United States, 19090
      • Research Site
    • Wynnewood, Pennsylvania, United States, 19096
      • Research Site
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Research Site
    • Providence, Rhode Island, United States, 02908
      • Research Site
    • Woonsocket, Rhode Island, United States, 02895
      • Research Site
  • South Carolina
    • Aiken, South Carolina, United States, 29801
      • Research Site
    • Charleston, South Carolina, United States, 29406
      • Research Site
    • Charleston, South Carolina, United States, 29414
      • Research Site
    • Columbia, South Carolina, United States, 29210
      • Research Site
    • Hilton Head Island, South Carolina, United States, 29926
      • Research Site
    • Myrtle Beach, South Carolina, United States, 29572
      • Research Site
    • Sumter, South Carolina, United States, 29150
      • Research Site
  • South Dakota
    • Aberdeen, South Dakota, United States, 57401
      • Research Site
    • Sioux Falls, South Dakota, United States, 57105
      • Research Site
    • Watertown, South Dakota, United States, 57201
      • Research Site
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Research Site
    • Knoxville, Tennessee, United States, 37920
      • Research Site
    • Memphis, Tennessee, United States, 38120
      • Research Site
    • Memphis, Tennessee, United States, 38104
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Research Site
  • Texas
    • Abilene, Texas, United States, 79606-5208
      • Research Site
    • Amarillo, Texas, United States, 79106
      • Research Site
    • Austin, Texas, United States, 78731
      • Research Site
    • Beaumont, Texas, United States, 77702
      • Research Site
    • Bedford, Texas, United States, 76022
      • Research Site
    • Bryan, Texas, United States, 77802
      • Research Site
    • Corpus Christi, Texas, United States, 78405
      • Research Site
    • Corpus Christi, Texas, United States, 78412
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • Dallas, Texas, United States, 75230-2510
      • Research Site
    • Dallas, Texas, United States, 75237
      • Research Site
    • El Paso, Texas, United States, 79915
      • Research Site
    • El Paso, Texas, United States, 79905
      • Research Site
    • Fort Worth, Texas, United States, 76104
      • Research Site
    • Garland, Texas, United States, 75042
      • Research Site
    • Harlingen, Texas, United States, 78550
      • Research Site
    • Houston, Texas, United States, 77055
      • Research Site
    • Irving, Texas, United States, 75063
      • Research Site
    • Longview, Texas, United States, 75601
      • Research Site
    • McAllen, Texas, United States, 78503-1298
      • Research Site
    • Mesquite, Texas, United States, 75150
      • Research Site
    • Midland, Texas, United States, 79701-5946
      • Research Site
    • Paris, Texas, United States, 75460-5004
      • Research Site
    • Richardson, Texas, United States, 75082
      • Research Site
    • Round Rock, Texas, United States, 78665
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78217
      • Research Site
    • Sherman, Texas, United States, 75090
      • Research Site
    • Southlake, Texas, United States, 76092
      • Research Site
    • Sugar Land, Texas, United States, 77479
      • Research Site
    • Temple, Texas, United States, 76508
      • Research Site
    • The Woodlands, Texas, United States, 77380
      • Research Site
    • Tyler, Texas, United States, 75702
      • Research Site
    • Tyler, Texas, United States, 75701
      • Research Site
    • Waco, Texas, United States, 76712
      • Research Site
    • Webster, Texas, United States, 77598
      • Research Site
    • Wichita Falls, Texas, United States, 76310
      • Research Site
  • Utah
    • Ogden, Utah, United States, 84403
      • Research Site
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • Research Site
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • Research Site
    • Fairfax, Virginia, United States, 22031
      • Research Site
    • Lynchburg, Virginia, United States, 24501
      • Research Site
    • Newport News, Virginia, United States, 23601
      • Research Site
    • Portsmouth, Virginia, United States, 23704
      • Research Site
  • Washington
    • Bremerton, Washington, United States, 98310
      • Research Site
    • Burien, Washington, United States, 98166
      • Research Site
    • Edmonds, Washington, United States, 98026
      • Research Site
    • Seattle, Washington, United States, 98133
      • Research Site
    • Spokane, Washington, United States, 99208
      • Research Site
    • Spokane, Washington, United States, 99218
      • Research Site
    • Spokane, Washington, United States, 99202
      • Research Site
    • Tacoma, Washington, United States, 98405
      • Research Site
    • Vancouver, Washington, United States, 98684
      • Research Site
    • Yakima, Washington, United States, 98902
      • Research Site
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54311
      • Research Site
    • Janesville, Wisconsin, United States, 53548
      • Research Site
    • Milwaukee, Wisconsin, United States, 53211
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with stage IV NSCLC (not recurrent or re-staged).
• Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
• Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
• 18 years of age or older at screening.
• Life expectancy greater than 6 months based on the judgment of the investigator and documented during screening.
• Hemoglobin level less than or equal to 11.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomization (retest in screening is acceptable).
• Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
• Subjects must have had a baseline scan (computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography-computer tomography [PET/CT]) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
• Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative.

Exclusion Criteria:

• Known primary benign or malignant hematologic disorder which can cause anemia.
• History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
• Received any prior adjuvant or neoadjuvant therapy for NSCLC.
• Subjects with a history of brain metastasis.
• Uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
• History of neutralizing antibody activity to recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
• Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.
• Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
• Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
• Known seropositivity for human immunodeficiency virus (HIV) or diagnosis of acquired immunodeficiency syndrome (AIDS), positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
• History of pure red cell aplasia
• History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
• Transferrin saturation < 20% and ferritin < 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
• Abnormal renal function (serum creatinine level > 2X upper limit of normal [ULN]) as assessed by the central laboratory during screening.
• Abnormal liver function (total bilirubin > 2X ULN or liver enzymes alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 2.5X ULN for subjects without liver metastasis or ≥ 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
• Received any red blood cell (RBC) transfusion within 28 days prior to randomization.
• Plan to receive any RBC transfusion between randomization and study day 1.
• Known previous treatment failure to erythropoiesis stimulating agents (ESAs) (eg, rHuEPO, darbepoetin alfa).
• ESA therapy within the 28 days prior to randomization.
• Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
• Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
• Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).
• Previously randomized to this study.
• Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.	Drug: Placebo; Administered subcutaneously once every 3 weeks
EXPERIMENTAL: Darbepoetin alfa; Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.	Drug: Darbepoetin alfa; Administered subcutaneously once every 3 weeks; Other Names: Aranesp®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival (OS) was defined as the time from randomization to the date of death due to any cause. Participants were censored on the date of last contact (ie, the date the participant was last known to be alive) if they were not known to have died.	From randomization until death or end of study; maximum time on follow-up was 93.6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Progression-free survival was defined as the time from randomization to the date of radiographic disease progression or death from any cause, whichever event occurred first. Participants without either event were censored on the date of their last disease assessment. Disease progression was based on the investigator's assessment of scans using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or 1.1 depending on the timing of enrollment.	From randomization until disease progression or death; maximum time on follow-up was 87.23 months.
Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin ≤ 8.0 g/dL From Week 5 to End of the Efficacy Treatment Period	Any red blood cell (RBC) transfusion (packed RBCs or whole blood) given or a hemoglobin ≤ 8.0 g/dL on or after study day 29 until the EOETP, inclusive.	Week 5 (day 29) to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.
Number of Participants With Adverse Events of Special Interest	Adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer to date, included the following categories: antibody-mediated pure red cell aplasia (PRCA), cardiac failure, central nervous system vascular disorders, convulsions, embolic and thrombotic events, hypersensitivity, hypertension, ischemic heart disease, malignancies, and severe cutaneous adverse reactions. Lack of efficacy and medication errors were also evaluated.	From first dose of study drug until 30 days after last dose; the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
Percentage of Participants With an Objective Tumor Response	Objective response was defined as the incidence of a complete or partial response at any time during the study. Response was determined by the investigator's assessment of the scans using RECIST version 1.0 or 1.1 depending on the timing of enrollment.	Day 1 to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.
Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa	Developing antibody incidence was defined as neutralizing antibody positive postbaseline with a negative or no result at baseline.	Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later. the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin ≤ 8.0 g/dL From Week 1 to End of the Efficacy Treatment Period	Any red blood cell (RBC) transfusion (packed RBCs or whole blood) given or a hemoglobin ≤ 8.0 g/dL on or after study day 1 until the EOETP, inclusive.	Week 1 to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
Change From Baseline in Hemoglobin to End of Efficacy Treatment Period	Post-baseline hemoglobin values within 28 days after a RBC transfusion were not be used in the calculation of change.	Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Gascon P, Nagarkar R, Smakal M, Syrigos KN, Barrios CH, Sanchez JC, Zhang L, Henry DH, Gordon D, Hirsh V, Kubota K, Orlov S, Thomas G, Steinmetz T, Kang JH, Tomita DK, Fleishman AN, Park JK, De Oliveira Brandao C. A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC. J Thorac Oncol. 2020 Feb;15(2):190-202. doi: 10.1016/j.jtho.2019.10.005. Epub 2019 Oct 16.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2009
• Primary Completion (ACTUAL): June 7, 2017
• Study Completion (ACTUAL): June 7, 2017

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (ESTIMATE): March 9, 2009

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: chemotherapy; NSCLC; lung cancer; non-small cell lung cancer; anemia; pleural effusion; Aranesp; darbepoetin alfa; malignant pleural effusion; advanced lung cancer; metastatic lung cancer; Stage IV lung cancer; chemotherapy induce anemia; Stage IIIB lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Hematologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: 20070782; 2007-005792-34 (EUDRACT_NUMBER)