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

This study has been terminated.
(Primary objective reached)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00858364
First received: March 5, 2009
Last updated: June 23, 2017
Last verified: June 2017
  Purpose
This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with stage IV NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 µg every 3 weeks <Q3W>, Group B: placebo Q3W)

Condition Intervention Phase
Non-Small Cell Lung Cancer Anemia Cancer Lung Cancer Drug: darbepoetin alfa 500 mcg Q3W Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: from randomization until death or end of study ]

Secondary Outcome Measures:
  • Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from study day 1 to end of efficacy treatment period [ Time Frame: study day 1 until end of efficacy treatment period ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from week 5 (day 29) to end of efficacy treatment period [ Time Frame: Study day 29 to end of efficacy treatment period ]
  • Incidence of adverse events (AEs) such as thrombovascular events (TVE), venous thromboembolic events (VTE), and AEs associated with Red Blood Cell (RBC) transfusions [ Time Frame: Randomization to 30 days after last dose of darbepoetin alfa ]
  • Change in hemoglobin from baseline to end of efficacy treatment period [ Time Frame: screening until end of efficacy treatment period ]
  • Objective tumor response [ Time Frame: randomization to subjects developing tumor progression ]
  • Progression-free survival (PFS) [ Time Frame: from randomization until disease progression ]

Enrollment: 2549
Actual Study Start Date: July 17, 2009
Study Completion Date: June 7, 2017
Primary Completion Date: June 7, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
darbepoetin alfa 500 µg (Q3W)
Drug: darbepoetin alfa 500 mcg Q3W
darbepoetin alfa 500 mcg (Q3W)
Placebo Comparator: B
Placebo Q3W
Drug: placebo
Placebo

Detailed Description:
Oversight Authorities continued: Colombia
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (CT, MRI, or 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 BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
  • History of neutralizing antibody activity to 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 HIV or diagnosis of 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 ULN) as assessed by the central laboratory during screening.
  • Abnormal liver function (total bilirubin > 2X ULN or liver enzymes ALT or 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 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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858364

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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, 08270-070
Research Site
Rio de Janeiro, Brazil, 22260-020
Research Site
Rio de Janeiro, Brazil, 22640-000
Research Site
Rio de Janeiro, Brazil, 22793-080
Research Site
São Paulo, Brazil, 01209-000
Research Site
São Paulo, Brazil, 01246-000
Bulgaria
Research Site
Plovdiv, Bulgaria, 4004
Research Site
Rousse, Bulgaria, 7002
Research Site
Sofia, Bulgaria, 1233
Research Site
Sofia, Bulgaria, 1784
Research Site
Varna, Bulgaria, 9000
Research Site
Varna, Bulgaria, 9010
Canada, New Brunswick
Research Site
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Research Site
Oshawa, Ontario, Canada, L1G 2B9
Research Site
Toronto, Ontario, Canada, M9N 1N8
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H2W 1S6
Research Site
Saint-Jerome, Quebec, Canada, J7Z 5T3
Chile
Research Site
Temuco, Cautín, Chile, 4810469
Research Site
Renaca, Valparaíso, Chile
Research Site
Santiago, Chile, 7500006
Research Site
Santiago, Chile, 7571831
Research Site
Santiago, Chile, 8380455
China, Beijing
Research Site
Beijing, Beijing, China, 100191
China, Chongqing
Research Site
Chongqing, Chongqing, China, 400038
China, Fujian
Research Site
Fuzhou, Fujian, China, 350001
Research Site
Fuzhou, Fujian, China, 350025
China, Gansu
Research Site
Lanzhou, Gansu, China, 730050
China, Guangdong
Research Site
Guangzhou, Guangdong, China, 510010
Research Site
Guangzhou, Guangdong, China, 510060
Research Site
Guangzhou, Guangdong, China, 510120
Research Site
Zhongshan, Guangdong, China, 528403
China, Hainan
Research Site
Haikou, Hainan, China, 570102
Research Site
Haikou, Hainan, China, 570311
China, Hebei
Research Site
Shijiazhuang, Hebei, China, 050011
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China, 150040
China, Hubei
Research Site
Wuhan, Hubei, China, 430030
Research Site
Wuhan, Hubei, China, 430070
China, Hunan
Research Site
Changsha, Hunan, China, 410013
China, Jiangsu
Research Site
Nanjing, Jiangsu, China, 210002
Research Site
Nanjing, Jiangsu, China, 210009
Research Site
Suzhou, Jiangsu, China, 215004
China, Jiangxi
Research Site
Nanchang, Jiangxi, China, 330006
China, Jilin
Research Site
Changchun, Jilin, China, 130012
Research Site
Changchun, Jilin, China, 130021
China, Liaoning
Research Site
Dalian, Liaoning, China, 116027
Research Site
Shenyang, Liaoning, China, 110016
Research Site
Shenyang, Liaoning, China, 110042
China, Shaanxi
Research Site
Xi An, Shaanxi, China, 710038
China, Shandong
Research Site
Jinan, Shandong, China, 250013
China, Sichuan
Research Site
Chengdu, Sichuan, China, 610041
Research Site
Chengdu, Sichuan, China, 610072
China, Xinjiang
Research Site
Urumqi, Xinjiang, China, 830000
China, Yunnan
Research Site
Kunming, Yunnan, China, 650032
Research Site
Kunming, Yunnan, China, 650118
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China, 310009
Research Site
Hangzhou, Zhejiang, China, 310016
Research Site
Hangzhou, Zhejiang, China, 310022
China
Research Site
Beijing, China, 100020
Research Site
Beijing, China, 100021
Research Site
Beijing, China, 100029
Research Site
Beijing, China, 100142
Research Site
Beijing, China, 101149
Research Site
Chongqing, China, 400030
Research Site
Chongqing, China, 400037
Research Site
Shanghai, China, 200003
Research Site
Shanghai, China, 200025
Research Site
Shanghai, China, 200032
Research Site
Shanghai, China, 200092
Research Site
Shanghai, China, 200127
Croatia
Research Site
Rijeka, Croatia, 51000
Research Site
Zagreb, Croatia, 10000
Czechia
Research Site
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
Praha 4, Czechia, 140 59
Research Site
Praha 8, Czechia, 180 81
Research Site
Pribram, Czechia, 261 01
Germany
Research Site
Bad Berka, Germany, 99437
Research Site
Bad Saarow, Germany, 15526
Research Site
Bamberg, Germany, 96049
Research Site
Grosshansdorf, Germany, 22927
Research Site
Halle (Saale), Germany, 06120
Research Site
Hemer, Germany, 58675
Research Site
Köln-Merheim, Germany, 51109
Research Site
Köln, Germany, 50677
Research Site
Moers, Germany, 47441
Research Site
München, Germany, 80336
Research Site
München, Germany, 81737
Research Site
München, Germany, 81925
Research Site
Münster, Germany, 48149
Research Site
Ulm, Germany, 89081
Greece
Research Site
Athens, Greece, 11527
Research Site
Athens, Greece, 12462
Research Site
Athens, Greece, 14564
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
Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Kowloon, Hong Kong
Research Site
New Territories, Hong Kong
India
Research Site
New Delhi, Delhi, India, 110 030
Research Site
Panaji, Goa, India, 403 001
Research Site
Ahmedabad, Gujarat, India, 380 009
Research Site
Bangalore, Karnataka, India, 560 054
Research Site
Belgaum, Karnataka, India, 590 010
Research Site
Mangalore, Karnataka, India, 575 001
Research Site
Kochi, Kerala, India, 682 304
Research Site
Bhopal, Madhya Pradesh, India, 462 001
Research Site
Ahmednagar, Maharashtra, India, 413 736
Research Site
Aurangabad, Maharashtra, India, 431 001
Research Site
Miraj, Maharashtra, India, 416 410
Research Site
Mumbai, Maharashtra, India, 400 012
Research Site
Nashik, Maharashtra, India, 422 002
Research Site
Nashik, Maharashtra, India, 422 004
Research Site
Nashik, Maharashtra, India, 422 005
Research Site
Pune, Maharashtra, India, 411 001
Research Site
Pune, Maharashtra, India, 411 004
Research Site
Pune, Maharashtra, India, 411 013
Research Site
Thane, Maharashtra, India, 400 607
Research Site
Jaipur, Rajasthan, India, 302 004
Research Site
Jaipur, Rajasthan, India, 302 013
Research Site
Chennai, Tamil Nadu, India, 600 018
Research Site
Madurai, Tamil Nadu, India, 625 107
Research Site
Lucknow, Uttar Pradesh, India, 226 003
Research Site
Kolkata, West Bengal, India, 700 016
Research Site
Kolkata, West Bengal, India, 700 026
Research Site
Bangalore, India, 560 029
Ireland
Research Site
Dublin, Ireland, 24
Research Site
Dublin, Ireland, 8
Israel
Research Site
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
Italy
Research Site
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
Japan
Research Site
Nagoya-shi, Aichi, Japan, 460-0001
Research Site
Fukui-Shi, Fukui, Japan, 910-8526
Research Site
Chikushino-shi, Fukuoka, Japan, 818-8516
Research Site
Kurume-shi, Fukuoka, Japan, 830-0011
Research Site
Amagasaki-shi, Hyogo, Japan, 660-8550
Research Site
Kobe-shi, Hyogo, Japan, 650-0017
Research Site
Kobe, Hyogo, Japan, 650-0047
Research Site
Nishinomiya-shi, Hyogo, Japan, 663-8501
Research Site
Kanazawa, Ishikawa, Japan, 920-8641
Research Site
Sagamihara-shi, Kanagawa, Japan, 252-0375
Research Site
Okayama-shi, Okayama, Japan, 700-8607
Research Site
Osaka-shi, Osaka, Japan, 541-8567
Research Site
Osaka-shi, Osaka, Japan, 545-8586
Research Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Research Site
Shinjuku-ku, Tokyo, Japan, 160-0023
Research Site
Yonago-shi, Tottori, Japan, 683-8504
Research Site
Kyoto, Japan, 615-8256
Korea, Republic of
Research Site
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 362-711
Research Site
Daegu, Korea, Republic of, 700-712
Research Site
Gwangju, Korea, Republic of, 519-763
Research Site
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Research Site
Seoul, Korea, Republic of, 134-791
Research Site
Seoul, Korea, Republic of, 135-710
Research Site
Seoul, Korea, Republic of, 136-705
Research Site
Seoul, Korea, Republic of, 137-701
Research Site
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Research Site
Ulsan, Korea, Republic of, 682-714
Luxembourg
Research Site
Esch-Sur-Alzette, Luxembourg, 4005
Research Site
Luxembourg, Luxembourg, 1210
Malaysia
Research Site
Kota Bharu, Kelantan, Malaysia, 16150
Research Site
Kuantan, Pahang, Malaysia, 25100
Research Site
Georgetown, Pinang, Malaysia, 10050
Research Site
Kota Kinabalu, Sabah, Malaysia, 88996
Research Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
Research Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Mexico
Research Site
Saltillo, Coahuila, Mexico, 25000
Research Site
Mexico City, Distrito Federal, Mexico, 06720
Research Site
Mexico City, Distrito Federal, Mexico, 14080
Research Site
Mexico City, Distrito Federal, Mexico, 14140
Research Site
Mexico, Distrito Federal, Mexico, 06100
Research Site
Mexico, Distrito Federal, Mexico, 06720
Research Site
Mexico, Distrito Federal, Mexico, 07300
Research Site
Leon, Guanajuato, Mexico, 37000
Research Site
Guadalajara, Jalisco, Mexico, 44340
Research Site
Zapopan, Jalisco, Mexico, 45200
Research Site
Monterrey, Nuevo León, Mexico, 64710
Research Site
Queretaro, Querétaro, Mexico, 76090
Research Site
San Luis Potosi, San Luis Potosí, Mexico, 78216
Research Site
Merida, Yucatán, Mexico, 97000
Research Site
Chihuahua, Mexico, 31217
Research Site
Colima, Mexico, 28030
Research Site
Oaxaca, Mexico, 68000
Research Site
Puebla, Mexico, 72270
Netherlands
Research Site
Breda, Netherlands, 4818 CK
Research Site
Eindhoven, Netherlands, 5623 EJ
Research Site
Rotterdam, Netherlands, 3015 CE
Research Site
Tilburg, Netherlands, 5022 GC
Philippines
Research Site
Davao City, Davao, Philippines, 8000
Research Site
Baguio City, Philippines, 2600
Research Site
Cebu City, Philippines, 6000
Research Site
Makati City, Philippines, 1229
Research Site
Manila, Philippines, 1000
Research Site
Manila, Philippines, 1008
Research Site
Metro Manila, Philippines, 1100
Research Site
Pasig City, MetroManila, Philippines, 1604
Research Site
Quezon City, Philippines, 1101
Research Site
Quezon City, Philippines, 1102
Poland
Research Site
Bydgoszcz, Poland, 85-796
Research Site
Glucholazy, Poland, 48-340
Research Site
Konin, Poland, 62-500
Research Site
Krakow, Poland, 31-202
Research Site
Krakow, Poland, 31-501
Research Site
Lomza, Poland, 18-404
Research Site
Olsztyn, Poland, 10-228
Research Site
Olsztyn, Poland, 10-357
Research Site
Rzeszow, Poland, 35-055
Research Site
Szczecin, Poland, 70-891
Research Site
Warszawa, Poland, 02-781
Puerto Rico
Research Site
San Juan, Puerto Rico, 00910
Research Site
San Juan, Puerto Rico, 00927
Romania
Research Site
Cluj Napoca, Romania, 400015
Research Site
Craiova, Romania, 200347
Research Site
Lasi, Romania, 700106
Research Site
Sibiu, Romania, 550245
Research Site
Suceava, Romania, 720237
Research Site
Timisoara, Romania, 300239
Russian Federation
Research Site
Arkhangelsk, Russian Federation, 163045
Research Site
Barnaul, Russian Federation, 656049
Research Site
Belgorod, Russian Federation, 308010
Research Site
Ivanovo, Russian Federation, 153013
Research Site
Kirov, Russian Federation, 610021
Research Site
Krasnodar, Russian Federation, 350000
Research Site
Kursk, Russian Federation, 305035
Research Site
Lipetsk, Russian Federation, 398005
Research Site
Moscow, Russian Federation, 115478
Research Site
Nizhniy Novgorod, Russian Federation, 603081
Research Site
Novosibirsk, Russian Federation, 630047
Research Site
Obninsk, Russian Federation, 249036
Research Site
Omsk, Russian Federation, 644013
Research Site
Orenburg, Russian Federation, 460021
Research Site
Penza, Russian Federation, 440071
Research Site
Pyatigorsk, Russian Federation, 357502
Research Site
Saint-Petersburg, Russian Federation, 197101
Research Site
Samara, Russian Federation, 443031
Research Site
Saratov, Russian Federation, 410004
Research Site
Stavropol, Russian Federation, 355047
Research Site
Tula, Russian Federation, 300040
Research Site
Tver, Russian Federation, 170008
Research Site
Ufa, Russian Federation, 450054
Research Site
Ulyanovsk, Russian Federation, 432063
Research Site
Voronezh, Russian Federation, 394000
Research Site
Yaroslavl, Russian Federation, 150054
Serbia
Research Site
Belgrade, Serbia, 11129
Research Site
Gornji Matejevac, Serbia, 18204
Research Site
Kragujevac, Serbia, 34000
Research Site
Sremska Kamenica, Serbia, 21204
Slovenia
Research Site
Golnik, Slovenia, 4204
Research Site
Pohorje, Slovenia, 2208
South Africa
Research Site
Umhlanga, KwaZulu-Natal, South Africa, 4320
Research Site
Bloemfontein, South Africa, 9301
Research Site
Johannesburg, South Africa, 1501
Research Site
Overport, South Africa, 4091
Research Site
Polokwane, South Africa, 0699
Spain
Research Site
Granada, Andalucía, Spain, 18014
Research Site
Las Palmas de Gran Canaria, Canarias, Spain, 35016
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
Alicante, Comunidad Valenciana, Spain, 03010
Research Site
Benidorm, Comunidad Valenciana, Spain, 03501
Research Site
Valencia, Comunidad Valenciana, Spain, 46017
Research Site
Pontevedra, Galicia, Spain, 36002
Switzerland
Research Site
Aarau, Switzerland, 5000
Research Site
Aarau, Switzerland, 5001
Research Site
Chur, Switzerland, 7000
Research Site
Sursee, Switzerland, 6210
Research Site
Zurich, Switzerland, 8063
Taiwan
Research Site
Changhua, Taiwan, 50006
Research Site
Kaohsiung, Taiwan, 81362
Research Site
Taichung, Taiwan, 40447
Research Site
Taichung, Taiwan, 40705
Research Site
Tainan, Taiwan, 70403
Research Site
Tainan, Taiwan, 710
Research Site
Tainan, Taiwan, 736
Ukraine
Research Site
Chernihiv, Ukraine, 14029
Research Site
Chernivtsi, Ukraine, 58013
Research Site
Dnipropetrovsk, Ukraine, 49102
Research Site
Kirovograd, Ukraine, 25011
Research Site
Kyiv, Ukraine, 03115
Research Site
Kyiv, Ukraine, 04107
Research Site
Lutsk, Ukraine, 43018
Research Site
Lviv, Ukraine, 79031
Research Site
Sumy, Ukraine, 40022
Research Site
Uzhgorod, Ukraine, 88000
Research Site
Vinnytsia, Ukraine, 21029
United Kingdom
Research Site
Bebington, United Kingdom, CH63 4JY
Research Site
Dorechester, United Kingdom, DT1 2JY
Research Site
Dorset, United Kingdom, BH15 2JB
Research Site
Liverpool, United Kingdom, L14 3PE
Research Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00858364     History of Changes
Other Study ID Numbers: 20070782
Study First Received: March 5, 2009
Last Updated: June 23, 2017

Keywords provided by Amgen:
darbepoetin alfa
non-small cell lung cancer
Aranesp
chemotherapy
chemotherapy induce anemia
advanced lung cancer
malignant pleural effusion
metastatic lung cancer
NSCLC
anemia
lung cancer
pleural effusion
Stage IIIB lung cancer
Stage IV lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Anemia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Hematologic Diseases
Darbepoetin alfa
Hematinics

ClinicalTrials.gov processed this record on August 18, 2017