Non-Small Cell Lung CancerPhase 3NCT00858364

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

A Phase 3 study testing Darbepoetin alfa in people with Non-Small Cell Lung Cancer and Anemia, run by Amgen at 566 sites in 37 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer, Anemia, Cancer
What is being tested?: Darbepoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,549 participants
Where: 566 sitesin 37 countries
Study dates: 17 Jul 2009to 7 Jun 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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.

Who cannot join

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.

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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).

Trial locations and contacts

566 sites in 37 countries.

Country

City, postcode or hospital

566 sites in 37 countries

United States277 sites

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Aberdeen, South Dakota, 57401
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Abilene, Texas, 79606-5208
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Aiken, South Carolina, 29801
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Akron, Ohio, 44304
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Albany, Georgia, 31701
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Albany, New York, 12208
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Albuquerque, New Mexico, 87109-4397
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Alexandria, Louisiana, 71301
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Amarillo, Texas, 79106
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Anaheim, California, 92801
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Anchorage, Alaska, 99508
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Anniston, Alabama, 36207
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Arcadia, California, 91007
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Asheboro, North Carolina, 27203
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Asheville, North Carolina, 28801
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Ashland, Kentucky, 41101
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Attleboro, Massachusetts, 02703
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Augusta, Georgia, 30901
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Austin, Texas, 78731
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Baltimore, Maryland, 21215
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Baltimore, Maryland, 21218
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Baltimore, Maryland, 21237
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Beaumont, Texas, 77702
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Bedford, Texas, 76022
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Berkeley, California, 94704
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Bethesda, Maryland, 20817
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Bethlehem, Pennsylvania, 18015
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Biloxi, Mississippi, 39531
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Birmingham, Alabama, 35216
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Bismarck, North Dakota, 58501
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Boston, Massachusetts, 02130
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Boston, Massachusetts, 02135
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Boynton Beach, Florida, 33426
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Boynton Beach, Florida, 33435
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Bremerton, Washington, 98310
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Bridgeport, Connecticut, 06610
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Brockton, Massachusetts, 02302
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Brooklyn, New York, 11212
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Bryan, Texas, 77802
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Buffalo, New York, 14215
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Burbank, California, 91505
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Burien, Washington, 98166
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Burlington, North Carolina, 27215
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Cambridge, Massachusetts, 02138
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Charleston, South Carolina, 29406
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Charleston, South Carolina, 29414
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Chevy Chase, Maryland, 20815
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Chicago, Illinois, 60616
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Chicago, Illinois, 60640
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Christiansburg, Virginia, 24073
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Clarkston, Michigan, 48346
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Columbia, Missouri, 65201
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Columbia, South Carolina, 29210
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Columbus, Ohio, 43235
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Concord, North Carolina, 28025
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Coral Springs, Florida, 33065
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Corpus Christi, Texas, 78405
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Corpus Christi, Texas, 78412
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Council Bluffs, Iowa, 51503
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Cumberland, Maryland, 21502
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Dallas, Texas, 75230-2510
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Dallas, Texas, 75231
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Dallas, Texas, 75237
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Dayton, Ohio, 45428
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Daytona Beach, Florida, 32114
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Denver, Colorado, 80210
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Denver, Colorado, 80218
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Downey, California, 90241
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Dubuque, Iowa, 52001
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Durham, North Carolina, 27704
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Edmonds, Washington, 98026
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El Paso, Texas, 79905
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El Paso, Texas, 79915
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Englewood, Colorado, 80113
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Fairfax, Virginia, 22031
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Fayetteville, Arkansas, 72703
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Fort Lauderdale, Florida, 33316
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Fort Worth, Texas, 76104
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Fountain Valley, California, 92708
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Frederick, Maryland, 21701
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Fresno, California, 93703
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Fresno, California, 93720
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Galesburg, Illinois, 61401
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Garland, Texas, 75042
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Gettysburg, Pennsylvania, 17325
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Glens Falls, New York, 12801
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Goldsboro, North Carolina, 27534
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Goshen, New York, 10924
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Grand Island, Nebraska, 68803
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Grand Rapids, Michigan, 49503
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Great Falls, Montana, 59405
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Green Bay, Wisconsin, 54311
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Greenville, North Carolina, 27834
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Gurnee, Illinois, 60031
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Hagerstown, Maryland, 21742
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Harlingen, Texas, 78550
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Hattiesburg, Mississippi, 39401
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Hazard, Kentucky, 41701
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Henderson, Nevada, 89052
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Hendersonville, North Carolina, 28791
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Hickory, North Carolina, 28602
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High Point, North Carolina, 27262
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Hilton Head Island, South Carolina, 29926
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Holiday, Florida, 34691
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Hollywood, Florida, 33021
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77055
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Huntersville, North Carolina, 28078
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Hutchinson, Kansas, 67502
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Indianapolis, Indiana, 46219
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Iowa City, Iowa, 52242
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Irving, Texas, 75063
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Jackson, Mississippi, 39216
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Jacksonville, Florida, 32256
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Janesville, Wisconsin, 53548
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Jefferson City, Missouri, 65101
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Johnson City, Tennessee, 37604
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Jonesboro, Arkansas, 72401
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Kalamazoo, Michigan, 49048
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Kalispell, Montana, 59901
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Kansas City, Missouri, 64111
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Kansas City, Missouri, 64132
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Kinston, North Carolina, 28501
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Kissimmee, Florida, 34741
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Knoxville, Tennessee, 37920
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La Verne, California, 91750
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Lafayette, Louisiana, 70503
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Lake Success, New York, 11042
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Lake Worth, Florida, 33461
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Lakeland, Florida, 33805
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Lancaster, California, 93534
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Langhorne, Pennsylvania, 19047
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Latham, New York, 12110-0610
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Lecanto, Florida, 34461
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Lewiston, Maine, 04240
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Little Rock, Arkansas, 72205
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Long Beach, California, 90822
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Longview, Texas, 75601
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Los Angeles, California, 90024
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Los Angeles, California, 90027
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Los Angeles, California, 90048
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Louisville, Kentucky, 40202
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Louisville, Kentucky, 40207
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Lynchburg, Virginia, 24501
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Manchester, New Hampshire, 03102
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Marrero, Louisiana, 70072
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Massillon, Ohio, 44646
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McAllen, Texas, 78503-1298
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Memphis, Tennessee, 38104
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Memphis, Tennessee, 38120
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Merced, California, 95348
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Mesquite, Texas, 75150
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Miami, Florida, 33133
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Michigan City, Indiana, 46360
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Middletown, Ohio, 45042
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Midland, Texas, 79701-5946
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Milwaukee, Wisconsin, 53211
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Mission Hills, California, 91345
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Montebello, California, 90640
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Morehead, Kentucky, 40351
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Mount Sterling, Kentucky, 40353
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Mount Vernon, Illinois, 62864
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Muncie, Indiana, 47303
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Myrtle Beach, South Carolina, 29572
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Nashville, Tennessee, 37203
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New Orleans, Louisiana, 70112
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New Port Richey, Florida, 34652
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New Port Richey, Florida, 34655
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Newport News, Virginia, 23601
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North Las Vegas, Nevada, 89086
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Nyack, New York, 10960
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Ogden, Utah, 84403
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Oklahoma City, Oklahoma, 73102
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Omaha, Nebraska, 68105
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Omaha, Nebraska, 68106
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Orange City, Florida, 32763
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Orlando, Florida, 32806
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Oxnard, California, 93030
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Paducah, Kentucky, 42001
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Paducah, Kentucky, 42003
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Palm Springs, California, 92262
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Paris, Texas, 75460-5004
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Pawtucket, Rhode Island, 02860
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Pembroke Pines, Florida, 33029
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Philadelphia, Pennsylvania, 19102
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Philadelphia, Pennsylvania, 19106
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Philadelphia, Pennsylvania, 19107
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Philadelphia, Pennsylvania, 19140
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Philadelphia, Pennsylvania, 19141
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Pinehurst, North Carolina, 28374
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Pismo Beach, California, 93449
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Pittsburgh, Pennsylvania, 15240
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Pomona, California, 91767
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Port Clinton, Ohio, 43452
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Portsmouth, Virginia, 23704
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Poughkeepsie, New York, 12601
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Providence, Rhode Island, 02908
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Raleigh, North Carolina, 27607
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Redlands, California, 92374
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Richardson, Texas, 75082
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Rockledge, Florida, 32955
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Rockport, Maine, 04856
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Round Rock, Texas, 78665
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Ruston, Louisiana, 71270
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Salinas, California, 93901
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San Antonio, Texas, 78217
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San Antonio, Texas, 78229
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San Diego, California, 92161
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Santa Fe, New Mexico, 87505
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Santa Rosa, California, 95403
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Seattle, Washington, 98133
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Sherman, Texas, 75090
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Shreveport, Louisiana, 71103
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Simi Valley, California, 93065
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Sioux City, Iowa, 51101
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Sioux Falls, South Dakota, 57105
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Skokie, Illinois, 60077
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Soquel, California, 95073
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Southfield, Michigan, 48075
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Southgate, Michigan, 48195
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Southington, Connecticut, 06489
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Southlake, Texas, 76092
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Sparta, New Jersey, 07871
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Spokane, Washington, 99202
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Spokane, Washington, 99208
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Spokane, Washington, 99218
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Springfield, Missouri, 65807
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St Louis, Missouri, 63110
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St Louis, Missouri, 63136
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St. Helena, California, 94574
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Staten Island, New York, 10301
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Staten Island, New York, 10310
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Stockbridge, Georgia, 30281
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Sugar Land, Texas, 77479
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Sumter, South Carolina, 29150
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Sylvania, Ohio, 43560
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Tamarac, Florida, 33321
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Teaneck, New Jersey, 07666
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Temple, Texas, 76508
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The Villages, Florida, 32159
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The Woodlands, Texas, 77380
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Thomasville, Georgia, 31792
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Titusville, Florida, 32796
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Torrance, California, 90501
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Towson, Maryland, 21204
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Tucson, Arizona, 85704
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Tulsa, Oklahoma, 74104
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Tupelo, Mississippi, 38801
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Tyler, Texas, 75701
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Tyler, Texas, 75702
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Upland, Pennsylvania, 19013
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Valhalla, New York, 10595
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Vallejo, California, 94589
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Vancouver, Washington, 98684
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Vineland, New Jersey, 08360
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Waco, Texas, 76712
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Washington, North Carolina, 27889
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Washington D.C., District of Columbia, 20037
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Washington D.C., District of Columbia, 20060
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Waterloo, Iowa, 50702
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Watertown, South Dakota, 57201
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Webster, Texas, 77598
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West Covina, California, 91790
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Westminster, Maryland, 21157
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Weston, Florida, 33331
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White River Junction, Vermont, 05009
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Wichita, Kansas, 67214
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Wichita Falls, Texas, 76310
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Willmar, Minnesota, 56201
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Willow Grove, Pennsylvania, 19090
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Woonsocket, Rhode Island, 02895
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Wooster, Ohio, 44691
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Worcester, Massachusetts, 01608
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Wynnewood, Pennsylvania, 19096
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Yakima, Washington, 98902

Other trials in United States

China47 sites

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Beijing, Beijing Municipality, 100191
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Beijing, 100020
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Beijing, 100021
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Beijing, 100029
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Beijing, 100142
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Beijing, 101149
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Changchun, Jilin, 130012
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Changchun, Jilin, 130021
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Changsha, Hunan, 410013
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Chengdu, Sichuan, 610041
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Chengdu, Sichuan, 610072
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Chongqing, Chongqing Municipality, 400038
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Chongqing, 400030
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Chongqing, 400037
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Dalian, Liaoning, 116027
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Fuzhou, Fujian, 350001
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Fuzhou, Fujian, 350025
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Guangzhou, Guangdong, 510010
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Guangzhou, Guangdong, 510060
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Guangzhou, Guangdong, 510120
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Haikou, Hainan, 570102
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Haikou, Hainan, 570311
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Hangzhou, Zhejiang, 310009
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Hangzhou, Zhejiang, 310016
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Hangzhou, Zhejiang, 310022
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Harbin, Heilongjiang, 150081
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Jinan, Shandong, 250013
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Kunming, Yunnan, 650032
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Kunming, Yunnan, 650118
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Lanzhou, Gansu, 730050
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Nanchang, Jiangxi, 330006
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Nanjing, Jiangsu, 210002
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Nanjing, Jiangsu, 210009
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Shanghai, 200003
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Shanghai, 200025
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Shanghai, 200032
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Shanghai, 200092
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Shanghai, 200127
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Shenyang, Liaoning, 110016
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Shenyang, Liaoning, 110042
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Shijiazhuang, Hebei, 050011
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Suzhou, Jiangsu, 215004
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Ürümqi, Xinjiang, 830000
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Wuhan, Hubei, 430030
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Wuhan, Hubei, 430070
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Xi'an, Shaanxi, 710038
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Zhongshan, Guangdong, 528403

Other trials in China

Brazil32 sites

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Belém, Pará, 66053-000
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Belo Horizonte, Minas Gerais, 30110-090
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Belo Horizonte, Minas Gerais, 30150-281
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Belo Horizonte, Minas Gerais, 30150-321
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Belo Horizonte, Minas Gerais, 30285-000
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Brasília, Federal District, 72110-150
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Cachoeiro de Itapemirim, Espírito Santo, 29308-020
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Campo Grande, Mato Grosso do Sul, 79010-050
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Curitba, Paraná, 81520-060
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Curitiba, Paraná, 80010-030
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Curitiba, Paraná, 80530-010
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Fortaleza, Ceará, 60336-045
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Fortaleza, Ceará, 60430-230
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Ijuí, Rio Grande do Sul, 98700-000
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Itajaí, Santa Catarina, 88301-220
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Londrina, Paraná, 86050-190
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Passo Fundo, Rio Grande do Sul, 99010-260
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Pelotas, Rio Grande do Sul, 96015-280
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Porto Alegre, Rio Grande do Sul, 90035-001
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Porto Alegre, Rio Grande do Sul, 90610-000
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Porto Alegre, Rio Grande do Sul, 90840-440
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Ribeirão Preto, São Paulo, 14015-130
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Rio de Janeiro, 22260-020
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Rio de Janeiro, 22640-000
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Rio de Janeiro, 22793-080
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Salvador, Estado de Bahia, 40170-110
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Santo André, São Paulo, 09060-650
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Santo André, São Paulo, 09090-780
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São José dos Campos, São Paulo, 12245-750
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São Paulo, São Paulo, 01221-020
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São Paulo, São Paulo, 08270-070
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São Paulo, 01246-000

Other trials in Brazil

Russia26 sites

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Arkhangelsk, 163045
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Barnaul, 656049
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Belgorod, 308010
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Ivanovo, 153013
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Kirov, 610021
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Krasnodar, 350000
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Kursk, 305035
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Lipetsk, 398005
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Moscow, 115478
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Nizhny Novgorod, 603081
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Novosibirsk, 630047
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Obninsk, 249036
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Omsk, 644013
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Orenburg, 460021
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Penza, 440071
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Pyatigorsk, 357502
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Saint Petersburg, 197101
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Samara, 443031
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Saratov, 410004
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Stavropol, 355047
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Tula, 300040
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Tver', 170008
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Ufa, 450054
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Ulyanovsk, 432063
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Voronezh, 394000
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Yaroslavl, 150040

Other trials in Russia

Japan17 sites

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Amagasaki-shi, Hyōgo, 660-8550
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Bunkyo-ku, Tokyo, 113-8603
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Chikushino-shi, Fukuoka, 818-8516
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Fukui-shi, Fukui, 910-8526
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Kanazawa, Ishikawa-ken, 920-8641
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Kobe, Hyōgo, 650-0017
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Kobe, Hyōgo, 650-0047
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Kurume-shi, Fukuoka, 830-0011
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Kyoto, 615-8256
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Nagoya, Aichi-ken, 460-0001
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Nishinomiya-shi, Hyōgo, 663-8501
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Okayama, Okayama-ken, 700-8607
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Osaka, Osaka, 541-8567
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Osaka, Osaka, 545-8586
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Sagamihara-shi, Kanagawa, 252-0375
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Shinjuku-ku, Tokyo, 160-0023
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Yonago-shi, Tottori, 683-8504

Other trials in Japan

Mexico17 sites

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Chihuahua City, 31217
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Colima, 28030
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Guadalajara, Jalisco, 44340
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León, Guanajuato, 37000
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Mérida, Yucatán, 97000
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Mexico City, Mexico City, 06100
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Mexico City, Mexico City, 06720
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Mexico City, Mexico City, 07300
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Mexico City, Mexico City, 14080
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Mexico City, Mexico City, 14140
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Monterrey, Nuevo León, 64710
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Oaxaca City, 68000
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Puebla City, 72270
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Querétaro City, Querétaro, 76090
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Saltillo, Coahuila, 25000
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San Luis Potosí City, San Luis Potosí, 78216
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Zapopan, Jalisco, 45200

Other trials in Mexico

India16 sites

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Ahilyanagar, Maharashtra, 413 736
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Ahmedabad, Gujarat, 380 009
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Bangalore, Karnataka, 560 054
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Bangalore, 560 029
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Bhopal, Madhya Pradesh, 462 001
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Chennai, Tamil Nadu, 600 018
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Chhatrapati Sambhajinagar, Maharashtra, 431 001
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Jaipur, Rajasthan, 302 004
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Jaipur, Rajasthan, 302 013
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Kochi, Kerala, 682 304
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Kolkata, West Bengal, 700 026
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Madurai, Tamil Nadu, 625 107
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Mangalore, Karnataka, 575 001
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New Delhi, National Capital Territory of Delhi, 110 030
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Panjim, Goa, 403 001
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Thane, Maharashtra, 400 607

Other trials in India

Italy13 sites

Research Site
Catania, 95122
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Faenza RA, 48018
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Grosseto, 58100
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Lecce, 73100
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Legnago VR, 37045
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Lugo RA, 48022
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Meldola FC, 47014
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Messina, 98125
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Milan, 20142
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Naples, 80131
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Ravenna, 48100
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Reggio Calabria, 89124
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San Giovanni Rotondo FG, 71013

Other trials in Italy

Argentina12 sites

Research Site
Buenos Aires, Distrito Federal, C1019ABS
Research Site
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About this study

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

Read the detailed description

Oversight Authorities continued: Colombia

Conditions: Non-Small Cell Lung Cancer, Anemia, Cancer, Lung Cancer
Being tested: Darbepoetin alfa, Placebo
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
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Anemia, Neoplasms, Lung Neoplasms, Pleural Effusion, Malignant, Pleural Effusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Darbepoetin alfaDrug
Also called Aranesp®
Administered subcutaneously once every 3 weeks
PlaceboDrug
Administered subcutaneously once every 3 weeks

Study groups in NCT00858364
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo
Darbepoetin alfa	Experimental	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. Receives: Drug: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From randomization until death or end of study; maximum time on follow-up was 93.6 months.

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 20097 Jun 2017

First posted9 Mar 2009 (estimated)
Study start17 Jul 2009
Primary completion7 Jun 2017
Study completion7 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,549 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00858364
Sponsor's protocol ID: 20070782
Other IDs: 2007-005792-34
Status last verified: Nov 2022
First submitted: 5 Mar 2009
Last updated: 30 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 31629060

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00858364
Acronym / sponsor ID: 20070782
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 2,549 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 17 Jul 2009 (actual)
Primary completion: 7 Jun 2017 (actual)
Study completion: 7 Jun 2017 (actual)
First posted: 9 Mar 2009 (estimated)
Results: Posted 6 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Oversight Authorities continued: Colombia

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants 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.
Darbepoetin alfa	Experimental	Drug: Darbepoetin alfaParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Darbepoetin alfaAlso: Aranesp®Administered subcutaneously once every 3 weeks	Drug	Darbepoetin alfa
PlaceboAdministered subcutaneously once every 3 weeks	Drug	Placebo

Primary outcome

Overall Survival (OS)
Time frame: From randomization until death or end of study; maximum time on follow-up was 93.6 months.
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.

7 secondary outcomes

Progression-free Survival (PFS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 6 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	846	642
Darbepoetin Alfa	1,703	1,246

Primary outcome: Overall Survival (OS)

Time frame: From randomization until death or end of study; maximum time on follow-up was 93.6 months.. Median (95% Confidence Interval). Unit: months

Measure	Placebo n = 836	Darbepoetin Alfa n = 1680
Value	9.260 (8.250 to 10.020)	9.460 (8.900 to 10.120)

Placebo vs Darbepoetin Alfa: Hazard Ratio (HR): 0.92 (95% CI 0.83 to 1.01)
Placebo vs Darbepoetin Alfa: Hazard Ratio (HR): 0.91 (95% CI 0.83 to 1.00)
Placebo vs Darbepoetin Alfa: p = 0.070, Stratified log-rank test

Population analysed: Primary analysis set (all randomized and consented participants with non-small cell lung cancer who received at least one dose of study drug)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	259 of 833 (31.1%)	674 of 833 (80.9%)	657 of 833
Darbepoetin Alfa	524 of 1,685 (31.1%)	1,319 of 1,685 (78.3%)	1,273 of 1,685

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31629060Gascon 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

566 sites in 37 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darbepoetin alfa in people with Non-Small Cell Lung Cancer and Anemia, run by Amgen at 566 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 566 sites in United States, China, Brazil, Russia, Japan and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization until death or end of study; maximum time on follow-up was 93.6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00858364, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.