None listed
Conditions
Interventions
Group 1 Type of group
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.
Group name:Group 2 Type of group
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.
Sponsors
AMGEN INC.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Subjects in metastatic stage (stage IV) or advanced stage IIIB with NSCLC malignant pleural effusion • Under treatment or about to receive first-line cyclic chemotherapy for NSCLC and expected to receive at least 2 additional cycles of cyclic chemotherapy • Life expectancy> 6 months based on the investigator´s judgment and documented during the scrutiny Status performance of the Eastern Cooperative Cancer Group (ECOG) of 0 or 1 as assessed during the scrutiny • 18 years of age or older during scrutiny • Subjects with chemotherapy-induced anemia defined by a hemoglobin level 2 ng / mL) and vitamin B12 (> 200 pg / mL) appropriate at the screening evaluated by the central laboratory (supplement and reexamination acceptable) • Before any specific study procedure, informed consent must be obtained from the subject in writing or from the valid legal representative
Exclusion criteria
Exclusion criteria: • Known malignant or benign primary hematologic disorder that could cause anemia • History of cancer or current active cancer (other than non-small cell lung cancer), with the exception of non-melanomatous skin cancer with curative resection, cervical carcinoma treated curatively in situ or other primary solid tumors treated curatively, without known active disease present and without curative treatment administered during the last 3 years. • 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 activity of neutralizing antibodies to rHuEPO or Darbepoietin alfa • Uncontrolled angina, uncontrolled heart failure or uncontrolled cardiac arrhythmia as determined by the investigator during screening. Subjects with myocardial infarction within 6 months prior to scrutiny. • Subjects with a history of seizure disorder who have received anticonvulsant medications within 30 days of scrutiny • Clinically important systemic infection or uncontrolled chronic inflammatory disease (eg rheumatoid arthritis, irritable bowel) at the time of screening as determined by e! investigator • Known seropositivity to human immunodeficiency virus (HIV), or diagnosis of acquired immunodeficiency syndrome (AIDS). Positive for superficial hepatitis B antigen or seropositive for hepatitis virus • History of pure red series aplasia • History of deep venous thrombosis or embolic event (for example: pulmonary embolism) during the 6 months prior to scrutiny • Known failure to a previous treatment for ESAs (eg rHuEPO, Darbepoietin alfa) • ESA therapy during the 28 days prior to scrutiny • Known hypersensitivity to recombinant ESAs or to the excipients contained in the research product • Transferrin saturation 2 times the upper limit of normal [ULN]) during screening • Abnormal liver function (total bilirubin> 2X ULN and liver enzymes alanine aminotransferase [ALT] or aspartate aminotransferase [AST]> 2.5X ULN for subjects without liver metastases or> 5X ULN for subjects with liver metastases) during scrutiny. Subjects with documented Gilbert´s syndrome may be eligible. • Have received any RBC transfusion within 28 days prior to randomization • Plan to receive any RBC transfusion between randomization and day 1 of the study • That they have less than 30 days of receiving any research product or device. The use / reception for research of a product or medical device that has been approved by the country´s local regulatory authorities for any indication is allowed • People of childbearing age who are pregnant, breastfeeding or who do not wish to have effective contraceptive precautions during the study and for at least one month after the last dose of the investigational product at the investigator´s discretion (including women of childbearing age who are partners of the male subjects) • Prior randomization in this study • The researcher´s doubts regarding the subject´s ability to provide written informed consent and / or to comply with the study procedures (including availability for follow-up visits)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Overall Survival (OS) Timepoints:From randomization until death or end of study; maximum time on follow-up was 93.6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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 investigators assessment of scans using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or 1.1 depending on the timing of enrollment. Measure:Progression-free Survival (PFS) Timepoints:From randomization until disease progression or death; maximum time on follow-up was 87.23 months. ; Outcome name: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. Measure: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 Timepoints: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 ; Outcome name: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. Measure:Number of Participants With Adverse Events of Special Interest Timepoints: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. ; Outcome name:Objective respon | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea South, Luxembourg, Malasya, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed