CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
enzastaurin +4 moredrug
Likely dose
enzastaurin 1125 milligramfrom 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/NCT00533429
NCT00533429Phase 2Completed

Protocol H6Q-MC-S034(a) Randomized, Double-Blind, Phase 2 Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Chemonaive Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Sep 21, 2007·Updated May 13, 2021

In Brief

A Phase 2 clinical trial evaluating enzastaurin, pemetrexed, and 3 other interventions for Non-small Cell Lung Cancer. Completed, enrolled 40 participants across 12 sites.

Detailed Summary

The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of participants with advanced stage non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.8 years ago

Interventions

enzastaurindrug

1125 milligram (mg) loading dose then 500 mg, oral, daily until disease progression

pemetrexeddrug

500 milligrams per square meter (mg/m\^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles

carboplatindrug

Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles

bevacizumabdrug

15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles

Placebodrug

oral, daily