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Type(s) of Cancer
Lung
Study Phase
Phase 2B
Study Completion Date
2014-01
NCT01439568Uploaded 01-23-2019
Available for Download
PDS UID: LungSm_EliLill_2011_287
A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma
Provider Information
Provider Data DescriptionThe primary objective was to compare the progression-free survival (PFS) between treatment arms. Secondary objectives were OS, overall response rate (ORR), duration of overall response (DOR), and safety.
SponsorEli Lilly
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset92
# of Patients Control46
# of Patients Experimental48
DOIhttps://doi.org/10.34949/bscb-ga21
CDISC StandardSDTM
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with extensive-stage disease small cell lung cancer (SCLC)
ConditionsExtensive Stage Small Cell Lung Carcinoma
Intervention TypeDrug: LY2510924
Drug: Carboplatin
Drug: Etoposide
Drug(s)Drug: LY2510924
Drug: Carboplatin
Drug: Etoposide
Total Enrolled90
RandomizationRandomized
Blinding MethodNone
Arms InterventionLY2510924 + Carboplatin + Etoposide - Experimental
Carboplatin + Etoposide - Active Comparator
Secondary IDI2V-MC-CXAC
PubMed (PMID)28236984
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLLilly Protocol LY2510924_CXAC.pdf
CRFLilly CRF LY2510924_CXAC.pdf
DATA DICTIONARYProc Contents Data Dictionary.docx
DATA (COMPARATOR ARM)Lilly data LY2510924_CXAC.zip
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