Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
This study is currently recruiting participants.
Verified February 2013 by Amgen
Information provided by (Responsible Party):
First received: March 5, 2009
Last updated: February 7, 2013
Last verified: February 2013
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)
Non-Small Cell Lung Cancer
Drug: darbepoetin alfa 500 mcg Q3W
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
||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
Primary Outcome Measures:
- Overall survival (OS) [ Time Frame: from randomization until death or end of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2017 (Final data collection date for primary outcome measure)
Active Comparator: A
darbepoetin alfa 500 µg (Q3W)
Drug: darbepoetin alfa 500 mcg Q3W
darbepoetin alfa 500 mcg (Q3W)
Placebo Comparator: B
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858364
|Contact: Amgen Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2009
||February 7, 2013
||Greece: Ministry of Health & Social Solidarity, National Organization for Medicines
Greece: National Ethics Committee
Argentina: Ministry of Health
Austria: Central Ethics Committee
Greece: National Organization for Medicines
Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Local Ethics Committees
Italy: Ministry of Health
Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.
Luxembourg: Comité National d'Ethique de Recherche
Luxembourg: Direction de la Santé, Division de la Pharmacie et des Médicaments
Mexico: Ministry of Health
Mexico: SSA (Secretaria de Salud Publica)
Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research
Netherlands: Medicines Evaluation Board
Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider
Phillippines: the Bureau of Food and Drugs
Poland: Drug Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romaina: National Medicines Agency
Romania: Ministry of Health and the Family
Romania: Romanian National Drug Agency
Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)
Russia: Ministry of Health
Serbia: Medicine and Medical Devices Agency of Serbia
Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP)
Slovenia: National Medical Ethics Committee (Komisija Republike Slovenije Za Medicinsko Etiko)
South Africa: Department of Health
Spain: reference Ethics Committee
Spain: Spanish Agency of Medicines
Spain: Spanish Drug Agency
Switzerland: Agency for Therapeutic Products
Switzerland: Local Ethics Committee
Taiwan: Department of Health
Taiwan: Taiwan Food and Drug Administration
Taiwan: Taiwan Provincial Department of Health
Ukraine: Ministry of Health
Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Institutional Review Board
Austria: Federal Ministry for Health and Women
Austria: Secretariat of Health
Belgium: Directorate general for the protection of Public health: Medicines
Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
Belgium: Pharmaceutical Inspectorate
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Health Canada
Canada: Institutional Review Board
Chile: Health Ministry
Croatia: Central Ethics Committee Sredisnje Eticko Povjerenstvo
Croatia: Ministarstvo zdravstva i socijalne skrbi (Ministry of Health and Social Welfare)
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Malaysia: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
South Korea: Institutional Review Board
Keywords provided by Amgen:
non-small cell lung cancer
advanced lung cancer
metastatic lung cancer
Stage IIIB lung cancer
Stage IV lung cancer
chemotherapy induce anemia
malignant pleural effusion
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases