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Lung (Small Cell)

A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

Unique Dataset IDLungSm_Amgen_2002_266
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients600Comparator (Control) Arm Enrolled Patients301Experimental (Active) Arm Enrolled Patients299RandomizationYesClinicalTrial.gov IDNCT00119613ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00119613?term=20010145&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapyDataset TypeADS

Clinical Trial Title

A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

Trial Summary and Conditions

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.

Data Summary

Control arm and experimental arm data including demographics, disease characteristics, safety and efficacy

Study Objectives

Primary Objective - 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. Secondary Objective - To evaluate whether darbepoetin alfa improves FACT-Fatigue subscale scores. Safety Objective - To assess the safety profile of darbepoetin alfa in subjects with previously untreated extensive stage SCLC. Study Design - Randomized, double-blind, placebo controlled, multicenter study. Eligible subjects will be randomized in a 1:1 ratio to treatment with darbepoetin alfa or placebo and will be stratified by region, ECOG performance status, and LDH level. Subjects will receive study drug (darbepoetin alfa or placebo) throughout the 6 cycles of chemotherapy and for 3 weeks after the last dose of chemotherapy. Subjects will be followed until death, or at the point at which all randomized subjects have completed their end of study treatment visit and 496 deaths have occurred. This will be the End of Study. Long term follow-up will run from the end of study until all subjects have died. Sample size - The planned sample size is approximately 600 subjects randomized in a 1:1 ratio Primary Endpoints - 1) change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period 2) survival time Secondary endpoints - 1) change to FACT-Fatigue subscale scores from baseline to the end of study treatment Safety Endpoints - 1) incidence of adverse events (including serious and treatment related), changes in laboratory values, changes in vital signs and incidence of concomitant medications.

Outcome Measures

Primary Outcome Measures 1.Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period [ Time Frame: from baseline to the end of the chemotherapy treatment period ] 2.Survival time Secondary Outcome Measures 1.Change in FACT-fatigue subscale scores from baseline to the end of study treatment [ Time Frame: from baseline to the end of study treatment ] 2.Incidence of Adverse Events (including serious and treatment related) [ Time Frame: Throughout study ] 3.Changes in laboratory values, changes in vital signs and incidence of concomitant medications [ Time Frame: Throughout study ]

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 20010145_01.20.01 Protocol Amend 2 2004-07-16 English_Redacted.pdf

CRF: Amgen 20010145 DDT - v2.pdf

DATA DICTIONARY: Amgen 20010145 DDT.pdf

DATA (BOTH COMPARATOR AND ACTIVE ARMS): SAS dataset - 20010145.zip

OTHER: Amgen 20010145 CRF PRO.pdf