CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 908 enrolled
Drug / intervention
pemetrexed +2 moredrug
Likely dose
pemetrexed 500 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00363415
NCT00363415Phase 3Completed
CompareCT.gov

A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Aug 15, 2006·Updated Oct 28, 2009

In Brief

A Phase 3 clinical trial evaluating pemetrexed, etoposide, and 1 other intervention for Small Cell Lung Cancer. Completed, enrolled 908 participants across 189 sites in 26 countries.

Detailed Summary

This 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, China, France, Germany, Greece, Hungary, India, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2006
Enrollment StartAug 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.9 years ago

Interventions

pemetrexeddrug

500 mg/m2, intravenous (IV), every 21 days x 6 cycles

etoposidedrug

100 mg/m2, intravenous (IV), days 1-3 x 6 cycles

carboplatindrug

Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles