None listed
Conditions
Interventions
Darbepoetin alfa and placebo will be considered investigational products for the purposes of maintaining the blind to treatment groups in this study.
Investigational product will be initiated on st
g, 300 μ
g, 200 μ
g or 100 μ
g per mL or placebo (without active drug). Each box will contain a single vial of IP. Investigational product will be blinded.
Approximately 3000 subjects with stage IV NSCLC will be randomized in
Group A: darbepoetin alfa 500 μ
g (Q3W) to a hemoglobin ceiling of 12.0 g/dL

Group B: placebo Q3W
Investigational Product (IP) will be given Q3W during the treatment period. IP will be discontinued within 3 weeks after the completion of chemotherapy, or upon the determinat
Sponsors
AMGEN INC.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease Related:  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. Demographic:  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 > 6 months based on the judgment of the investigator and documented during screening. Laboratory:  Hemoglobin level ≤ 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 (≥ 2 ng/mL) and vitamin B12 (≥ 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening. Imaging:  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. Ethical:  Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative.
Exclusion criteria
Exclusion criteria: Disease Related:  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. Laboratory:  Transferrin saturation 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. Medications:  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. General:  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 s
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Germany, Greece, India, Italy, Japan, Korea South, Luxembourg, Malasya, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactElvira Mogrovejo
IQVIA RDS Peru S.R.L
Outcome results
None listed