Trial · NCT00858364
Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
NCT00858364, Phase 3, Terminated, Amgen; results first posted 2018-07-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy. Trials, record NCT00858364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00858364
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
- NCT number
- NCT00858364
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,549 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Non-Small Cell Lung Cancer, Anemia, Cancer, Lung Cancer
- Interventions
- Darbepoetin alfa, Placebo
- First posted
- 2009-03-09
- Last updated
- 2022-11-30
- Other registries' IDs
- eudract:2007-005792-34
- Results first posted
- 2018-07-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization until death or end of study; maximum time on follow-up was 93.6 months. | 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. |
| Secondary | Progression-free Survival (PFS) | From randomization until disease progression or death; maximum time on follow-up was 87.23 months. | 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. |
| 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 | 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. | 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. |
| Secondary | Number of Participants With Adverse Events of Special Interest | 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. | 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. |
| Secondary | Percentage of Participants With an Objective Tumor Response | 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. | 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. |
| Secondary | Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa | 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. | Developing antibody incidence was defined as neutralizing antibody positive postbaseline with a negative or no result at baseline. |
| 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 | 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. | 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. |
| Secondary | Change From Baseline in Hemoglobin to End of Efficacy Treatment Period | 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. | Post-baseline hemoglobin values within 28 days after a RBC transfusion were not be used in the calculation of change. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization until death or end of study; maximum time on follow-up was 93.6 months. | Primary analysis set (all randomized and consented participants with non-small cell lung cancer who received at least one dose of study drug) | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From randomization until disease progression or death; maximum time on follow-up was 87.23 months. | The radiographic endpoint primary analysis set includes all participants in the primary analysis set who did not have disease progression prior to randomization. | months | MEDIAN |
| 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 | 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. | Primary analysis set participants who were on study as of day 29 | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events of Special Interest | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With an Objective Tumor Response | 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. | The radiographic endpoint primary analysis set includes all participants in the primary analysis set who did not have disease progression prior to randomization. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa | 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. | Randomized and consented participants who received at least one dose of study drug and with a postbaseline result. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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. | Primary analysis set | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin to End of Efficacy Treatment Period | 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. | 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. | g/dL | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Placebo | 9.260 | 95% Confidence Interval 8.250 to 10.020 | months | |
| Overall Survival (OS) | Darbepoetin Alfa | 9.460 | 95% Confidence Interval 8.900 to 10.120 | months | |
| Progression-free Survival (PFS) | Placebo | 4.340 | 95% Confidence Interval 4.170 to 4.700 | months | |
| Progression-free Survival (PFS) | Darbepoetin Alfa | 4.800 | 95% Confidence Interval 4.370 to 5.320 | months | |
| 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 | Placebo | 29.2 | percentage of participants | ||
| 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 | Darbepoetin Alfa | 22.5 | percentage of participants | ||
| Number of Participants With Adverse Events of Special Interest | Placebo | Any adverse events of interest | 157 | Participants | |
| Number of Participants With Adverse Events of Special Interest | Darbepoetin Alfa | Any adverse events of interest | 369 | Participants | |
| Number of Participants With Adverse Events of Special Interest | Placebo | Antibody-mediated pure red cell aplasia | 20 | Participants | |
| Number of Participants With Adverse Events of Special Interest | Darbepoetin Alfa | Antibody-mediated pure red cell aplasia | 51 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 846 | |
| Overall Study | STARTED | Darbepoetin Alfa | 1,703 | |
| Overall Study | Received Study Drug | Placebo | 837 | |
| Overall Study | Received Study Drug | Darbepoetin Alfa | 1,681 | |
| Overall Study | COMPLETED | Placebo | 642 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 1,246 | |
| Overall Study | NOT COMPLETED | Placebo | 204 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 457 |
Source ClinicalTrials.gov
Adverse events2,170
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Agranulocytosis | Blood and lymphatic system disorders | Placebo | 1 | 833 | |
| other | Agranulocytosis | Blood and lymphatic system disorders | Darbepoetin Alfa | 0 | 1,685 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 244 | 833 | |
| other | Anaemia | Blood and lymphatic system disorders | Darbepoetin Alfa | 451 | 1,685 | |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Placebo | 0 | 833 | |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Darbepoetin Alfa | 1 | 1,685 | |
| other | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Placebo | 0 | 833 | |
| other | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Darbepoetin Alfa | 1 | 1,685 | |
| other | Bandaemia | Blood and lymphatic system disorders | Placebo | 0 | 833 | |
| other | Bandaemia | Blood and lymphatic system disorders | Darbepoetin Alfa | 1 | 1,685 |
1 to 10 of 2,170Source ClinicalTrials.gov
See all 2,170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 657 | 833 |
| Total, all-cause mortality | Darbepoetin Alfa | 1,273 | 1,685 |
| Total, other adverse events | Placebo | 674 | 833 |
| Total, other adverse events | Darbepoetin Alfa | 1,319 | 1,685 |
| Total, serious adverse events | Placebo | 259 | 833 |
| Total, serious adverse events | Darbepoetin Alfa | 524 | 1,685 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31629060 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Darbepoetin Alfa vs Placebo: Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa | Trial comparisons |
| Darbepoetin Alfa vs Placebo: deaths from any cause | Trial comparisons |
| Darbepoetin Alfa vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00858364
GET https://conductscience.org/api/trials/v1/NCT00858364/results?page=2