Neoplasms

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Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

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Pleural Effusion

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Hematologic Diseases

Hematinics

All Drugs and Chemicals

Darbepoetin alfa

Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.

Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.

Administered subcutaneously once every 3 weeks

Placebo

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.

Oversight Authorities continued: Colombia

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

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.

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.

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.

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.

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.

Developing antibody incidence was defined as neutralizing antibody positive postbaseline with a negative or no result at baseline.

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.

Post-baseline hemoglobin values within 28 days after a RBC transfusion were not be used in the calculation of change.

Amgen

The safety population included all randomized and consented participants who received at least 1 dose of study drug. Four participants in the placebo group received at least 1 dose of darbepoetin alfa during the study and were included in the darbepoetin alfa group for safety analyses.

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Darbepoetin Alfa

Total

Age, Continuous

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Stratification factor at the time of randomization.

The primary analysis set includes all randomized and consented participants with non-small cell lung cancer who received at least one dose of study drug.

Geographic Region

Stratification factor at the time of randomization

Histology

Screening Hemoglobin

Study Director

The primary analysis used the Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.

As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.

To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).

Primary analysis set (all randomized and consented participants with non-small cell lung cancer who received at least one dose of study drug)

Overall Survival (OS)

The primary analysis of PFS used a Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.

The radiographic endpoint primary analysis set includes all participants in the primary analysis set who did not have disease progression prior to randomization.

Progression-free Survival (PFS)

The primary analysis of the incidence of a transfusion or hemoglobin ≤ 8.0 g/dL from day 29 to EOETP was based on the Cochran-Mantel-Haenszel method to test for treatment group differences while adjusting for the randomization stratification factors (geographic region, histology, and screening hemoglobin).

As a sensitivity analysis a logistic regression analysis was conducted, stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).

Primary analysis set participants who were on study as of day 29

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 adverse events of interest

Antibody-mediated pure red cell aplasia

Cardiac failure

Central nervous system vascular disorders

Convulsions

Embolic and thrombotic events

Embolic and thrombotic events, arterial

Embolic and thrombotic events, venous

Embolic and thrombotic events, unspecified/mixed

Hypersensitivity

Hypertension

Ischaemic heart disease

Lack of efficacy/effect

Malignancies

Medication errors

Severe cutaneous adverse reactions

All randomized and consented participants who received at least 1 dose of study drug. Four participants in the placebo group received at least 1 dose of darbepoetin alfa during the study and were included in the darbepoetin alfa group for safety analyses.

Number of Participants With Adverse Events of Special Interest

Percentage of Participants With an Objective Tumor Response

Randomized and consented participants who received at least one dose of study drug and with a postbaseline result.

Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa

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

Primary analysis set with available baseline and at least 1 postbaseline value; if the EOETP value was missing, the last available postbaseline value was used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy	NCT00858364	Non-Small Cell ... Anemia Cancer Lung Cancer	Darbepoetin alf... Placebo	18 Years -	Amgen
Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy	NCT00858364	Non-Small Cell ... Anemia Cancer Lung Cancer	Darbepoetin alf... Placebo	18 Years -	Amgen

Spots Global Cancer Trial Database for chemotherapy induce anemia