Last updated on July 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Small Cell Lung Cancer | Lung Cancer | Cancer | Anemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    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;
    ample obtained within 7 days prior to randomization (retest in screening is
    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.

You may not be eligible for this study if the following are true:

  • 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).

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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