CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 633 enrolled
Drug / intervention
Pemetrexed +2 moredrug
Likely dose
Pemetrexed 500 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/NCT00982111
NCT00982111Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Eli Lilly and Company·interventional·Posted Sep 22, 2009·Updated Jan 11, 2022

In Brief

A Phase 3 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 633 participants across 101 sites in 20 countries.

Detailed Summary

The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesAustralia, Austria, Belgium, Brazil, Canada, Croatia, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, United Kingdom, United States
CollaboratorsQuintiles, Inc., Parexel, PPD Development, LP, Medidata Solutions, Laboratory Corporation of America, University of Colorado, Denver, Thermo Fisher Scientific, Inc, Pacific Biomarkers, Intertek, Sysmex Inostics GmbH

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2009
Enrollment StartNov 2, 2009
Primary CompletionNov 14, 2012
Study CompletionDec 23, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 16.8 years ago

Interventions

Pemetrexeddrug

500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatindrug

75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Necitumumabbiological

800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.