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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00858364
• Other study ID #: 20070782
• Secondary ID: 2007-005792-34
• Status: Terminated
• Phase: Phase 3
• Start date: July 17, 2009
• Est. completion date: June 7, 2017

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.

Description:

Oversight Authorities continued: Colombia

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2549
• Est. completion date: June 7, 2017
• Est. primary completion date: June 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography-computer tomography [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 blood pressure [BP] > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.

• History of neutralizing antibody activity to recombinant human erythropoietin (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 human immunodeficiency virus (HIV) or diagnosis of acquired immunodeficiency syndrome (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 upper limit of normal [ULN]) as assessed by the central laboratory during screening.

• Abnormal liver function (total bilirubin > 2X ULN or liver enzymes alanine aminotransferase [ALT] or aspartate aminotransferase [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 red blood cell (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 erythropoiesis stimulating agents (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).

Related Conditions & MeSH terms

• Anemia
• Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Darbepoetin alfa
Administered subcutaneously once every 3 weeks
• Placebo
Administered subcutaneously once every 3 weeks

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad Autónoma de Buenos Aires	Distrito Federal
Argentina	Research Site	Ciudad Autónoma de Buenos Aires	Distrito Federal
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	La Rioja
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Argentina	Research Site	San Salvador de Jujuy	Jujuy
Argentina	Research Site	Santa Fe
Austria	Research Site	Steyr
Austria	Research Site	Wien
Belgium	Research Site	Ieper
Belgium	Research Site	Libramont
Belgium	Research Site	Liège
Belgium	Research Site	Namur
Belgium	Research Site	Ottignies
Brazil	Research Site	Belem	Pará
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Brasilia	Distrito Federal
Brazil	Research Site	Cachoeiro de Itapemirim	Espírito Santo
Brazil	Research Site	Campo Grande	Mato Grosso Do Sul
Brazil	Research Site	Curitba	Paraná
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Fortaleza	Ceará
Brazil	Research Site	Fortaleza	Ceará
Brazil	Research Site	Ijui	Rio Grande Do Sul
Brazil	Research Site	Itajaí	Santa Catarina
Brazil	Research Site	Londrina	Paraná
Brazil	Research Site	Passo Fundo	Rio Grande Do Sul
Brazil	Research Site	Pelotas	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Ribeirao Preto	São Paulo
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Salvador	Bahia
Brazil	Research Site	Santo Andre	São Paulo
Brazil	Research Site	Santo Andre	São Paulo
Brazil	Research Site	Sao Jose dos Campos	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	São Paulo
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
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China	Research Site	Beijing
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China	Research Site	Haikou	Hainan
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Serbia	Research Site	Belgrade
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Spain	Research Site	Alicante	Comunidad Valenciana
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Switzerland	Research Site	Aarau
Switzerland	Research Site	Aarau
Switzerland	Research Site	Chur
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United States	Research Site	Ashland	Kentucky
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United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Beaumont	Texas
United States	Research Site	Bedford	Texas
United States	Research Site	Berkeley	California
United States	Research Site	Bethesda	Maryland
United States	Research Site	Bethlehem	Pennsylvania
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United States	Research Site	Charleston	South Carolina
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United States	Research Site	Christiansburg	Virginia
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United States	Research Site	Saint Helena	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Salinas	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Santa Fe	New Mexico
United States	Research Site	Santa Rosa	California
United States	Research Site	Seattle	Washington
United States	Research Site	Sherman	Texas
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Simi Valley	California
United States	Research Site	Sioux City	Iowa
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	Skokie	Illinois
United States	Research Site	Soquel	California
United States	Research Site	Southfield	Michigan
United States	Research Site	Southgate	Michigan
United States	Research Site	Southington	Connecticut
United States	Research Site	Southlake	Texas
United States	Research Site	Sparta	New Jersey
United States	Research Site	Spokane	Washington
United States	Research Site	Spokane	Washington
United States	Research Site	Spokane	Washington
United States	Research Site	Springfield	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Staten Island	New York
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Sugar Land	Texas
United States	Research Site	Sumter	South Carolina
United States	Research Site	Sylvania	Ohio
United States	Research Site	Syracuse	New York
United States	Research Site	Tacoma	Washington
United States	Research Site	Tamarac	Florida
United States	Research Site	Teaneck	New Jersey
United States	Research Site	Temple	Texas
United States	Research Site	The Villages	Florida
United States	Research Site	The Woodlands	Texas
United States	Research Site	Thomasville	Georgia
United States	Research Site	Titusville	Florida
United States	Research Site	Torrance	California
United States	Research Site	Towson	Maryland
United States	Research Site	Tucson	Arizona
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Tyler	Texas
United States	Research Site	Tyler	Texas
United States	Research Site	Upland	Pennsylvania
United States	Research Site	Valhalla	New York
United States	Research Site	Vallejo	California
United States	Research Site	Vancouver	Washington
United States	Research Site	Vineland	New Jersey
United States	Research Site	Waco	Texas
United States	Research Site	Washington	North Carolina
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Waterloo	Iowa
United States	Research Site	Watertown	South Dakota
United States	Research Site	Webster	Texas
United States	Research Site	West Covina	California
United States	Research Site	Westminster	Maryland
United States	Research Site	Weston	Florida
United States	Research Site	White River Junction	Vermont
United States	Research Site	Wichita	Kansas
United States	Research Site	Wichita Falls	Texas
United States	Research Site	Willmar	Minnesota
United States	Research Site	Willow Grove	Pennsylvania
United States	Research Site	Woonsocket	Rhode Island
United States	Research Site	Wooster	Ohio
United States	Research Site	Worcester	Massachusetts
United States	Research Site	Wynnewood	Pennsylvania
United States	Research Site	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Czechia,  Germany,  Greece,  Hong Kong,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Luxembourg,  Malaysia,  Mexico,  Netherlands,  Philippines,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovenia,  South Africa,  Spain,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

References & Publications (1)

Gascon P, Nagarkar R, Smakal M, Syrigos KN, Barrios CH, Sanchez JC, Zhang L, Henry DH, Gordon D, Hirsh V, Kubota K, Orlov S, Thomas G, Steinmetz T, Kang JH, Tomita DK, Fleishman AN, Park JK, De Oliveira Brandao C. A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC. J Thorac Oncol. 2020 Feb;15(2):190-202. doi: 10.1016/j.jtho.2019.10.005. Epub 2019 Oct 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	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.	From randomization until death or end of study; maximum time on follow-up was 93.6 months.
Secondary	Progression-free Survival (PFS)	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 investigator's assessment of scans using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or 1.1 depending on the timing of enrollment.	From randomization until disease progression or death; maximum time on follow-up was 87.23 months.
Secondary	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	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.	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.
Secondary	Number of Participants With Adverse Events of Special Interest	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.	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.
Secondary	Percentage of Participants With an Objective Tumor Response	Objective response was defined as the incidence of a complete or partial response at any time during the study. Response was determined by the investigator's assessment of the scans using RECIST version 1.0 or 1.1 depending on the timing of enrollment.	Day 1 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.
Secondary	Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa	Developing antibody incidence was defined as neutralizing antibody positive postbaseline with a negative or no result at baseline.	Baseline and 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. the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
Secondary	Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin = 8.0 g/dL From Week 1 to End of the Efficacy Treatment Period	Any red blood cell (RBC) transfusion (packed RBCs or whole blood) given or a hemoglobin = 8.0 g/dL on or after study day 1 until the EOETP, inclusive.	Week 1 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); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
Secondary	Change From Baseline in Hemoglobin to End of Efficacy Treatment Period	Post-baseline hemoglobin values within 28 days after a RBC transfusion were not be used in the calculation of change.	Baseline and 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); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.

External Links

•   AmgenTrials clinical trials website