Clinical trial NCT00858364: Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Anemia
Cancer
Lung Cancer
Keywords: 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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 2549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Oversight Authorities continued: Colombia

Eligibility 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 (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).

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until death or end of study; maximum time on follow-up was 93.6 months.
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From randomization until disease progression or death; maximum time on follow-up was 87.23 months.
measure: 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
timeFrame: 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.
measure: Number of Participants With Adverse Events of Special Interest
timeFrame: 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.
measure: Percentage of Participants With an Objective Tumor Response
timeFrame: 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.
measure: Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Change From Baseline in Hemoglobin to End of Efficacy Treatment Period
timeFrame: 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.
Other outcomes:
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country: United States
facility: Research Site
state: Texas
city: Temple
country: United States
facility: Research Site
state: Texas
city: The Woodlands
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Webster
country: United States
facility: Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: White River Junction
country: United States
facility: Research Site
state: Vermont
city: Christiansburg
country: United States
facility: Research Site
state: Virginia
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Lynchburg
country: United States
facility: Research Site
state: Virginia
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Portsmouth
country: United States
facility: Research Site
state: Virginia
city: Bremerton
country: United States
facility: Research Site
state: Washington
city: Burien
country: United States
facility: Research Site
state: Washington
city: Edmonds
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Vancouver
country: United States
facility: Research Site
state: Washington
city: Yakima
country: United States
facility: Research Site
state: Washington
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: Janesville
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Research Site
state: Córdoba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Research Site
state: Distrito Federal
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Research Site
state: Distrito Federal
city: San Salvador de Jujuy
country: Argentina
facility: Research Site
state: Jujuy
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Research Site
city: La Rioja
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Steyr
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Ieper
country: Belgium
facility: Research Site
city: Libramont
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
state: Bahia
city: Fortaleza
country: Brazil
facility: Research Site
state: Ceará
city: Fortaleza
country: Brazil
facility: Research Site
state: Ceará
city: Brasilia
country: Brazil
facility: Research Site
state: Distrito Federal
city: Cachoeiro de Itapemirim
country: Brazil
facility: Research Site
state: Espírito Santo
city: Campo Grande
country: Brazil
facility: Research Site
state: Mato Grosso Do Sul
city: Belo Horizonte
country: Brazil
facility: Research Site
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Research Site
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Research Site
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Research Site
state: Minas Gerais
city: Curitba
country: Brazil
facility: Research Site
state: Paraná
city: Curitiba
country: Brazil
facility: Research Site
state: Paraná
city: Curitiba
country: Brazil
facility: Research Site
state: Paraná
city: Londrina
country: Brazil
facility: Research Site
state: Paraná
city: Belem
country: Brazil
facility: Research Site
state: Pará
city: Ijui
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Itajaí
country: Brazil
facility: Research Site
state: Santa Catarina
city: Ribeirao Preto
country: Brazil
facility: Research Site
state: São Paulo
city: Santo Andre
country: Brazil
facility: Research Site
state: São Paulo
city: Santo Andre
country: Brazil
facility: Research Site
state: São Paulo
city: Sao Jose dos Campos
country: Brazil
facility: Research Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Research Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Research Site
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint-Jerome
country: Canada
facility: Research Site
state: Quebec
city: Temuco
country: Chile
facility: Research Site
state: Cautín
city: Renaca
country: Chile
facility: Research Site
state: Valparaíso
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Lanzhou
country: China
facility: Research Site
state: Gansu
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Zhongshan
country: China
facility: Research Site
state: Guangdong
city: Haikou
country: China
facility: Research Site
state: Hainan
city: Haikou
country: China
facility: Research Site
state: Hainan
city: Shijiazhuang
country: China
facility: Research Site
state: Hebei
city: Harbin
country: China
facility: Research Site
state: Heilongjiang
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Nanchang
country: China
facility: Research Site
state: Jiangxi
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Dalian
country: China
facility: Research Site
state: Liaoning
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: XI An
country: China
facility: Research Site
state: Shaanxi
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Urumqi
country: China
facility: Research Site
state: Xinjiang
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Rijeka
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Benesov U Prahy
country: Czechia
facility: Research Site
city: Horovice
country: Czechia
facility: Research Site
city: Kutna Hora
country: Czechia
facility: Research Site
city: Kyjov
country: Czechia
facility: Research Site
city: Nova Ves pod Plesi
country: Czechia
facility: Research Site
city: Ostrava-Poruba
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 8
country: Czechia
facility: Research Site
city: Pribram
country: Czechia
facility: Research Site
city: Bad Berka
country: Germany
facility: Research Site
city: Köln-Merheim
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Chania
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Nea Kifissia, Athens
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Kowloon
country: Hong Kong
facility: Research Site
city: New Territories
country: Hong Kong
facility: Research Site
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Panaji
country: India
facility: Research Site
state: Goa
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Kochi
country: India
facility: Research Site
state: Kerala
city: Bhopal
country: India
facility: Research Site
state: Madhya Pradesh
city: Ahmednagar
country: India
facility: Research Site
state: Maharashtra
city: Aurangabad
country: India
facility: Research Site
state: Maharashtra
city: Thane
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Bangalore
country: India
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kefar Saba
country: Israel
facility: Research Site
city: Poria Eylit
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Faenza RA
country: Italy
facility: Research Site
city: Grosseto
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Legnago VR
country: Italy
facility: Research Site
city: Lugo RA
country: Italy
facility: Research Site
city: Meldola FC
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Reggio Calabria
country: Italy
facility: Research Site
city: San Giovanni Rotondo FG
country: Italy
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Fukui-Shi
country: Japan
facility: Research Site
state: Fukui
city: Chikushino-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Amagasaki-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Okayama-shi
country: Japan
facility: Research Site
state: Okayama
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Research Site
state: Tokyo
city: Yonago-shi
country: Japan
facility: Research Site
state: Tottori
city: Kyoto
country: Japan
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Seongnam-si, Gyeonggido
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Esch-Sur-Alzette
country: Luxembourg
facility: Research Site
city: Luxembourg
country: Luxembourg
facility: Research Site
city: Kota Bharu
country: Malaysia
facility: Research Site
state: Kelantan
city: Kuantan
country: Malaysia
facility: Research Site
state: Pahang
city: Georgetown
country: Malaysia
facility: Research Site
state: Pinang
city: Kota Kinabalu
country: Malaysia
facility: Research Site
state: Sabah
city: Kuala Lumpur
country: Malaysia
facility: Research Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Research Site
state: Wilayah Persekutuan
city: Saltillo
country: Mexico
facility: Research Site
state: Coahuila
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Leon
country: Mexico
facility: Research Site
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Queretaro
country: Mexico
facility: Research Site
state: Querétaro
city: San Luis Potosi
country: Mexico
facility: Research Site
state: San Luis Potosí
city: Merida
country: Mexico
facility: Research Site
state: Yucatán
city: Chihuahua
country: Mexico
facility: Research Site
city: Colima
country: Mexico
facility: Research Site
city: Oaxaca
country: Mexico
facility: Research Site
city: Puebla
country: Mexico
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
state: Davao
city: Krakow
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Rzeszow
country: Poland
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Kursk
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Ulyanovsk
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Gornji Matejevac
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
city: Golnik
country: Slovenia
facility: Research Site
city: Pohorje
country: Slovenia
facility: Research Site
city: Umhlanga
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Bloemfontein
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Overport
country: South Africa
facility: Research Site
city: Polokwane
country: South Africa
facility: Research Site
city: Granada
country: Spain
facility: Research Site
state: Andalucía
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Canarias
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Benidorm
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Pontevedra
country: Spain
facility: Research Site
state: Galicia
city: Aarau
country: Switzerland
facility: Research Site
city: Aarau
country: Switzerland
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Sursee
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Kirovograd
country: Ukraine
facility: Research Site
city: Bebington
country: United Kingdom
facility: Research Site
city: Dorechester
country: United Kingdom
facility: Research Site
city: Dorset
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.