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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
June 2008
NCT00363415Uploaded 01-30-2015
Available for Download
PDS UID: LungNo_ELiLill_2006_116
A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
Provider Information
Provider Data DescriptionThe primary objective of the study is to compare the overall survival of previously untreated patients with ED-SCLC after treatment with pemetrexed plus carboplatin versus etoposide plus carboplatin. The secondary objectives of the study are to assess and compare the following variables between treatment arms: - overall survival among a subgroup of patients classified as ?sensitive? with respect to the results of a prospectively defined set of biomolecular assays -time-to-event variables, including: - objective progression-free survival (PFS) - survival without Grade 4 toxicity (G4 SWT) - survival without Grade 3-4 toxicity (G3-4 SWT) - time to worsening of HRQoL (health-related quality of life) (TWQ) - objective tumor response - time-to-event variables and objective tumor response among the subgroup of patients classified as ?sensitive? with respect to the results of a prospectively defined set of biomolecular assays -changes in dimensions of HRQoL - the safety and adverse event profile (including Common Terminology Criteria for Adverse Events [CTCAE Version 3.0,
SponsorEli Lilly
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset908
# of Patients Control455
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/cdng-5908
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.
ConditionsSmall Cell Lung Cancer
Intervention TypeDrug: pemetrexed
Drug: etoposide
Drug: carboplatin
Drug(s)Drug: pemetrexed
Drug: carboplatin
Drug: etoposide
Total Enrolled908
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionA - Experimental
B - Active Comparator
Secondary IDH3E-MC-JMHO
PubMed (PMID)19720897
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
China
France
Germany
Greece
Hungary
India
Italy
Korea, Republic of
Netherlands
New Zealand
Poland
Portugal
Puerto Rico
Romania
Russian Federation
South Africa
Spain
Taiwan
Turkey
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLJMHO_protocol(b).pdf
CRFJMHO_CRFs.pdf
DATA DICTIONARYJMHO Data Def ADSRequirementFinal(01AUG08_03_29).pdf
DATA (COMPARATOR ARM)jmho_deid_control_trt.zip
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