Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 2: null- Non-Small Cell Lung Cancer Anemia Cancer Lung Cancer
Conditions
Interventions
Intervention1: Arm A - Intervention: Drug: darbepoetin alfa 500 mcg: darbepoetin alfa 500 mcg Q3W (every 3 weeks) till end of chemotherapy or disease progression, whichever occurs first
Control Inte
Sponsors
Amgen Technology Pvt Ltd
Amgen Technology Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 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; sample obtained within 7 days prior to randomization (retest in screening is acceptable). 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 .
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 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 Gilberts 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 countrys 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Timepoint: from randomization until death or end of study.[ Designated as safety issue: Yes ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hemoglobin from baseline to end of efficacy treatment periodTimepoint: screening until end of efficacy treatment period;Incidence of adverse events (AEs) such as thrombovascular events (TVE), venous thromboembolic events (VTE), and AEs associated with RBC transfusionsTimepoint: Randomization to 30 days after last dose of darbepoetin alfa;Incidence of at least 1 RBC transfusion or hemoglobin less than or equal to 8.0 g/dL from study day 1 to end of treatment periodTimepoint: study day 1 until end of efficacy treatment period;Incidence of at least 1 RBC transfusion or hemoglobin less than or equal to 8.0 g/dL from week 5 (day 29) to end of efficacy treatment periodTimepoint: Study day 29 to end of efficacy treatment period;Incidence of neutralizing antibody formation to darbepoetin alfaTimepoint: first dose of investigational product to the end of treatment period;Objective tumor responseTimepoint: randomization to subjects developing tumor progression;Progression-free survival (PFS)Timepoint: from randomization until death or end of study.[ Designated as safety issue: Yes ] | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Veena Jaguste
Amgen Technology Pvt. Ltd
Outcome results
None listed