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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careActive18 and overPharmaceutical / Industry20070782
NCT00858364

Trial Description

Summary

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)

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 (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).

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen, Incorporated

MDStudy Director

Amgen Call CenterPh: 866-572-6436

Trial Sites

U.S.A.
Alaska
  Anchorage
 Research Site
Arizona
  Tucson
 Research Site
Arkansas
  Jonesboro
 Research Site
  Little Rock
 Research Site
California
  Anaheim
 Research Site
  Los Angeles
 Research Site
  Mission Hills
 Research Site
  Oxnard
 Research Site
  Palm Springs
 Research Site
  Saint Helena
 Research Site
  San Diego
 Research Site
  Santa Rosa
 Research Site
  Torrance
 Research Site
  Vallejo
 Research Site
Colorado
  Englewood
 Research Site
Connecticut
  Southington
 Research Site
District of Columbia
  Washington
 Research Site
Florida
  Boynton Beach
 Research Site
  Fort Lauderdale
 Research Site
  Holiday
 Research Site
  Lakeland
 Research Site
  New Port Richey
 Research Site
Georgia
  Augusta
 Research Site
  Stockbridge
 Research Site
  Thomasville
 Research Site
Illinois
  Chicago
 Research Site
  Skokie
 Research Site
Kansas
  Hutchinson
 Research Site
  Wichita
 Research Site
Kentucky
  Louisville
 Research Site
Louisiana
  Lafayette
 Research Site
  Marrero
 Research Site
  Shreveport
 Research Site
Maine
  Lewiston
 Research Site
Maryland
  Baltimore
 Research Site
  Cumberland
 Research Site
  Frederick
 Research Site
  Towson
 Research Site
Massachusetts
  Attleboro
 Research Site
  Cambridge
 Research Site
Mississippi
  Biloxi
 Research Site
  Hattiesburg
 Research Site
Missouri
  Jefferson City
 Research Site
  Kansas City
 Research Site
Montana
  Great Falls
 Research Site
Nebraska
  Omaha
 Research Site
New York
  Syracuse
 Research Site
  Valhalla
 Research Site
North Carolina
  Asheboro
 Research Site
  Goldsboro
 Research Site
  Greenville
 Research Site
  High Point
 Research Site
  Kinston
 Research Site
  Washington
 Research Site
Ohio
  Sylvania
 Research Site
Pennsylvania
  Bethlehem
 Research Site
  Gettysburg
 Research Site
  Philadelphia
 Research Site
  Willow Grove
 Research Site
South Carolina
  Charleston
 Research Site
  Hilton Head Island
 Research Site
South Dakota
  Watertown
 Research Site
Tennessee
  Knoxville
 Research Site
  Memphis
 Research Site
Texas
  Abilene
 Research Site
  Amarillo
 Research Site
  Bryan
 Research Site
  Corpus Christi
 Research Site
  Dallas
 Research Site
  Fredericksburg
 Research Site
  Houston
 Research Site
  McAllen
 Research Site
  Mesquite
 Research Site
  Paris
 Research Site
  Round Rock
 Research Site
  San Antonio
 Research Site
Washington
  Bremerton
 Research Site
  Spokane
 Research Site
Argentina
  Cordoba
 Research Site
  San Miguel de Tucuman
 Research Site
Santa Fe
  Rosario
 Research Site
Belgium
  Ieper
 Research Site
  Libramont
 Research Site
  Liège
 Research Site
Brazil
  Belem
 Research Site
  Belo Horizonte
 Research Site
  Cachoeiro de Itapemirim
 Research Site
  Fortaleza
 Research Site
  Ijui
 Research Site
  Itajaí
 Research Site
  Passo Fundo
 Research Site
  Pelotas
 Research Site
  Porto Alegre
 Research Site
  Salvador
 Research Site
  São Paulo
 Research Site
Sao Paulo
  Santo Andre
 Research Site
Canada
  Moncton
 Research Site
Quebec
  Montreal
 Research Site
  Saint-Jerome
 Research Site
Chile
  Santiago
 Research Site
  Temuco
 Research Site
  Vina del Mar
 Research Site
China
  Beijing
 Research Site
  Changchun
 Research Site
  Changsha
 Research Site
  Chengdu
 Research Site
  Chongqing
 Research Site
  Dalian
 Research Site
  Fuzhou
 Research Site
  Guangzhou
 Research Site
  Hangzhou
 Research Site
  Harbin
 Research Site
  Jinan
 Research Site
  Kunming
 Research Site
  Lanzhou
 Research Site
  Nanchang
 Research Site
  Nanjing
 Research Site
  Shanghai
 Research Site
  Shenyang
 Research Site
  Shijiazhuang
 Research Site
  Suzhou
 Research Site
  Urumqi
 Research Site
  Wuhan
 Research Site
  Xi An
 Research Site
  Zhongshan
 Research Site
Czech Republic
  Benesov u Prahy
 Research Site
  Horovice
 Research Site
  Kyjov
 Research Site
  Ostrava-Poruba
 Research Site
  Praha 8
 Research Site
Germany
  Bad Berka
 Research Site
  Bamberg
 Research Site
  Grosshansdorf
 Research Site
  Halle (Saale)
 Research Site
  Hemer
 Research Site
  Köln
 Research Site
  München
 Research Site
  Ulm
 Research Site
Greece
  Athens
 Research Site
  Chania
 Research Site
  Larissa
 Research Site
  Nea Kifissia, Athens
 Research Site
  Piraeus
 Research Site
  Thessaloniki
 Research Site
Hong Kong
  Hong Kong
 Research Site
  Kowloon
 Research Site
  New Territories
 Research Site
India
  Ahmednagar
 Research Site
  Aurangabad
 Research Site
  Jaipur
 Research Site
  Kolkata
 Research Site
  Lucknow
 Research Site
  Miraj
 Research Site
  Mumbai
 Research Site
  Nashik
 Research Site
  New Delhi
 Research Site
  Panaji
 Research Site
  Pune
 Research Site
Tamil Nadu
  Chennai
 Research Site
  Madurai
 Research Site
Israel
  Poria Eylit
 Research Site
Italy
  Catania
 Research Site
  Grosseto
 Research Site
  Lecce
 Research Site
  Milano
 Research Site
Luxembourg
  Differdange
 Research Site
  Luxembourg
 Research Site
Malaysia
  Kota Bharu
 Research Site
  Kota Kinabalu
 Research Site
  Kuala Lumpur
 Research Site
  Kuantan
 Research Site
Mexico
  Colima
 Research Site
  Leon
 Research Site
  Oaxaca
 Research Site
  Queretaro
 Research Site
Jalisco
  Guadalajara
 Research Site
Netherlands
  Breda
 Research Site
  Rotterdam
 Research Site
Philippines
  Baguio City
 Research Site
  Cebu City
 Research Site
  Davao City
 Research Site
  Makati City
 Research Site
  Manila
 Research Site
  Metro Manila
 Research Site
  Pasig City, MetroManila
 Research Site
  Quezon City
 Research Site
Poland
  Bydgoszcz
 Research Site
  Glucholazy
 Research Site
  Krakow
 Research Site
  Suwalki
 Research Site
  Szczecin
 Research Site
  Warszawa
 Research Site
  Wroclaw
 Research Site
Puerto Rico
  San Juan
 Research Site
Republic of Bulgaria
  Plovdiv
 Research Site
  Sofia
 Research Site
  Varna
 Research Site
Republic of Korea
  Daegu
 Research Site
  Seongnam-si, Gyeonggi-do
 Research Site
  Seoul
 Research Site
Republic of South Africa
  Bloemfontein
 Research Site
  Johannesburg
 Research Site
  Overport
 Research Site
  Polokwane
 Research Site
Romania
  Cluj Napoca
 Research Site
  Craiova
 Research Site
  Lasi
 Research Site
  Suceava
 Research Site
  Timisoara
 Research Site
Russia
  Arkhangelsk
 Research Site
  Ivanovo
 Research Site
  Kirov
 Research Site
  Moscow
 Research Site
  Novosibirsk
 Research Site
  Obninsk
 Research Site
  Orenburg
 Research Site
  Penza
 Research Site
  Pyatigorsk
 Research Site
  Saratov
 Research Site
  St Petersburg
 Research Site
  Stavropol'
 Research Site
  Ufa
 Research Site
  Voronezh
 Research Site
  Yaroslavl
 Research Site
Serbia
  Gornji Matejevac
 Research Site
  Kragujevac
 Research Site
  Sremska Kamenica
 Research Site
Slovenia
  Pohorje
 Research Site
Spain
  Alicante
 Research Site
  Barcelona
 Research Site
  Granada
 Research Site
  Las Palmas de Gran Canaria
 Research Site
  Pontevedra
 Research Site
  Valencia
 Research Site
Taiwan
  Changhua
 Research Site
  Taichung City
 Research Site
  Tainan
 Research Site
Ukraine
  Chernihiv
 Research Site
  Chernivtsi
 Research Site
  Dnipropetrovsk
 Research Site
  Kyiv
 Research Site
  Lutsk
 Research Site
  Lviv
 Research Site
  Sumy
 Research Site
  Uzhgorod
 Research Site
  Vinnytsia
 Research Site
United Kingdom
  Liverpool
 Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00858364
ClinicalTrials.gov processed this data on October 22, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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