drugset / Trial / NCT00119613
A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.
Timeline
- Start
- 2002-12
- Primary completion
- 2007-01
- Completion
- 2007-04
Outcome
Mixed primary results
paper treatment with darbepoetin alpha maintained hemoglobin levels significantly higher than placebo (P < .001). PMID 18467726 ↗
paper There was no statistically significant difference in overall survival between the treatment groups (hazard ratio [HR], 0.93; 95% CI, 0.78 to 1.11; P = .431). PMID 18467726 ↗
Publications
- Results Pirker R, Ramlau RA, Schuette W, Zatloukal P, Ferreira I, Lillie T, Vansteenkiste JF. Safety and efficacy of darbepoetin alpha in previously untreated extensive-stage small-cell lung cancer treated with platinum plus etoposide. J Clin Oncol. 2008 May 10;26(14):2342-9. doi: 10.1200/JCO.2007.15.0748.
- Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 300 ug | — |