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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 IDNCT01439568DownloadableYes
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