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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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)

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer; Anemia; Cancer; Lung Cancer	Drug: darbepoetin alfa 500 mcg Q3W; Drug: placebo	Phase 3

Detailed Description:

Oversight Authorities continued: Colombia

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2549 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Supportive Care
Official Title:	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
Actual Study Start Date :	July 17, 2009
Actual Primary Completion Date :	June 7, 2017
Actual Study Completion Date :	June 7, 2017

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: A; darbepoetin alfa 500 µg (Q3W)	Drug: darbepoetin alfa 500 mcg Q3W; darbepoetin alfa 500 mcg (Q3W)
Placebo Comparator: B; Placebo Q3W	Drug: placebo; Placebo

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Overall survival (OS) [ Time Frame: from randomization until death or end of study ]

Secondary Outcome Measures :

1. Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ]
2. 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 ]
3. 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 ]
4. 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 ]
5. Change in hemoglobin from baseline to end of efficacy treatment period [ Time Frame: screening until end of efficacy treatment period ]
6. Objective tumor response [ Time Frame: randomization to subjects developing tumor progression ]
7. Progression-free survival (PFS) [ Time Frame: from randomization until disease progression ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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:

• 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).

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 632 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AmgenTrials clinical trials website 

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00858364 History of Changes
Other Study ID Numbers:	20070782
First Posted:	March 9, 2009
Last Update Posted:	December 2, 2017
Last Verified:	November 2017

Keywords provided by Amgen:

darbepoetin alfa; non-small cell lung cancer; Aranesp; chemotherapy; chemotherapy induce anemia; advanced lung cancer; malignant pleural effusion	metastatic lung cancer; NSCLC; anemia; lung cancer; pleural effusion; Stage IIIB lung cancer; Stage IV lung cancer

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Anemia; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms	Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Hematologic Diseases; Darbepoetin alfa; Hematinics