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Lung (Small Cell)

A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma

Unique Dataset IDLungSm_EliLill_2011_287ClinicalTrial.gov IDNCT01439568
DownloadableYes
SponsorEli LillyData ProviderEli LillyTotal Study Enrolled Patients92Comparator (Control) Arm Enrolled Patients46Experimental (Active) Arm Enrolled Patients48RandomizationYes
Study PhaseClinical Study Phase IIBBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeChemotherapyDataset TypeSDTM

Clinical Trial Title

A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma

Trial Summary and Conditions

The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in patients with extensive-stage disease small cell lung cancer (SCLC)

Data Summary

Data files include raw and SDTM data on safety, efficacy, demographics, etc. for all study subjects

Study Objectives

The 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.

Outcome Measures

Primary Outcome Measures : 1. Progression Free Survival [ Time Frame: Baseline to measured progressive disease or date of death from any cause (estimate 2 years) ] Secondary Outcome Measures : 1. Number of participants achieving an objective Tumor response, (Objective Response Rate) [ Time Frame: Baseline to date of tumor response or measured progressive disease or date of death

Available Downloads:

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

PROTOCOL: Lilly Protocol LY2510924_CXAC.pdf

CRF: Lilly CRF LY2510924_CXAC.pdf

DATA DICTIONARY: Proc Contents Data Dictionary.docx

DATA (COMPARATOR ARM): Lilly data LY2510924_CXAC.zip