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

This study is currently recruiting participants.
Verified March 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00858364
First received: March 5, 2009
Last updated: March 26, 2014
Last verified: March 2014

March 5, 2009
March 26, 2014
June 2009
February 2017   (final data collection date for primary outcome measure)
Overall survival (OS) [ Time Frame: from randomization until death or end of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00858364 on ClinicalTrials.gov Archive Site
  • Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ] [ Designated as safety issue: Yes ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from study day 1 to end of efficacy treatment period [ Time Frame: study day 1 until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from week 5 (day 29) to end of efficacy treatment period [ Time Frame: Study day 29 to end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) such as thrombovascular events (TVE), venous thromboembolic events (VTE), and AEs associated with Red Blood Cell (RBC) transfusions [ Time Frame: Randomization to 30 days after last dose of darbepoetin alfa ] [ Designated as safety issue: Yes ]
  • Change in hemoglobin from baseline to end of efficacy treatment period [ Time Frame: screening until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: randomization to subjects developing tumor progression ] [ Designated as safety issue: Yes ]
  • Progression-free survival (PFS) [ Time Frame: from randomization until disease progression ] [ Designated as safety issue: Yes ]
  • Progression-free survival (PFS) [ Time Frame: from randomization until disease progression ] [ Designated as safety issue: Yes ]
  • 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 period [ Time Frame: Study day 29 to end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) such as thrombovascular events (TVE), venous thromboembolic events (VTE), and AEs associated with RBC transfusions [ Time Frame: Randomization to 30 days after last dose of darbepoetin alfa ] [ Designated as safety issue: Yes ]
  • Objective tumor response [ Time Frame: randomization to subjects developing tumor progression ] [ Designated as safety issue: Yes ]
  • 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 period [ Time Frame: study day 1 until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Change in hemoglobin from baseline to end of efficacy treatment period [ Time Frame: screening until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV 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 <Q3W>, Group B: placebo Q3W)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Non-Small Cell Lung Cancer
  • Anemia
  • Cancer
  • Lung Cancer
  • Drug: darbepoetin alfa 500 mcg Q3W
    darbepoetin alfa 500 mcg (Q3W)
  • Drug: placebo
    Placebo
  • Active Comparator: A
    darbepoetin alfa 500 µg (Q3W)
    Intervention: Drug: darbepoetin alfa 500 mcg Q3W
  • Placebo Comparator: B
    Placebo Q3W
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
June 2019
February 2017   (final data collection date for primary outcome measure)

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:

  • 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).
Both
18 Years and older
No
Contact: Amgen Call Center 866-572-6436
United States,   Argentina,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Croatia,   Czech Republic,   Germany,   Greece,   Hong Kong,   India,   Ireland,   Israel,   Italy,   Korea, Republic of,   Luxembourg,   Malaysia,   Mexico,   Netherlands,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovenia,   South Africa,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom
 
NCT00858364
20070782
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP