Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
Basic Trial Information
|Phase III||Supportive care||18 and over||20070782|
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)
Before any study-specific procedure, the appropriate written informed consent must be
obtained from the subject or a legally accepted representative.
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.
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.
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
Life expectancy greater than 6 months based on the judgment of the investigator and
documented during screening.
18 years of age or older at screening.
Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21
days prior to randomization.
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.
Subjects with stage IV NSCLC (not recurrent or re-staged).
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).
Previously randomized to this study.
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).
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.
Known hypersensitivity to recombinant ESAs or the excipients contained within the
ESA therapy within the 28 days prior to randomization.
Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).
Plan to receive any RBC transfusion between randomization and study day 1.
Received any RBC transfusion within 28 days prior to randomization.
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.
Abnormal renal function (serum creatinine level > 2X ULN) as assessed by the central
laboratory during screening.
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).
History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6
months prior to randomization.
History of pure red cell aplasia
Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface
antigen, or seropositive for hepatitis C virus
Clinically significant systemic infection or uncontrolled chronic inflammatory
disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the
investigator during screening.
Subjects with a history of seizure disorder taking anti-seizure medication within 30
days prior to randomization.
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.
History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.
Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as
determined by the investigator during screening.
Subjects with a history of brain metastasis.
Received any prior adjuvant or neoadjuvant therapy for NSCLC.
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.
Known primary benign or malignant hematologic disorder which can cause anemia.
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
UCLA / Jonsson Comprehensive Cancer Center
John Anthony Glaspy
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00858364
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.