Lung Cancer 20070782

May 09, 2017

Sponsor: Amgen

Number: 20070782 

Eligible patients who enroll in the study will be randomly assigned (by chance) to this double-blind (There will be two groups, the patient and the doctors will not know which group the patient is in. The key that identifies the subjects and which group they belonged to is kept by a third party, and is not revealed to the researchers until the study is over), placebo-controlled (A placebo-controlled trial compares a new treatment with a an inactive drug or treatment) phase 3 non-inferiority study (a trial intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin) in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV. Stage IV cancer is the development of secondary malignant growths at a distance from a primary site of cancer. 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 , Group B: placebo Q3W)

Who’s eligible:

  • Patients must have stage IV NSCLC (not recurrent or re-staged). They should be 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. ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis
  • Patients must have a life expectancy greater than 6 months based on the judgment of the investigator and documented during screening.
  • 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.
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut- The Cancer Center of Central Connecticut.

Cancer Clinical Research Office