CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,093 enrolled
Drug / intervention
Necitumumab +2 morebiological
Likely dose
Not stated in 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/NCT00981058
NCT00981058Phase 3Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Sep 22, 2009·Updated Jun 18, 2025

In Brief

A Phase 3 clinical trial evaluating Necitumumab, Gemcitabine, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 1,093 participants across 182 sites in 26 countries.

Detailed Summary

The research study is testing the investigational drug necitumumab (IMC-11F8) 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 gemcitabine 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, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
CollaboratorsParexel, PPD Development, LP, Medidata Solutions, Laboratory Corporation of America, University of Colorado, Denver, Thermo Fisher Scientific FS, ICON Clinical Research, Pacific Biomarkers, Sysmex Inostics GmbH, Intertek

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2009
Enrollment StartJan 7, 2010
Primary CompletionJun 17, 2013
Study CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.8 years ago

Interventions

Necitumumabbiological

Administered intravenously. Continues until progressive disease, toxicity, noncompliance, or withdrawal.

Gemcitabinedrug

Administered intravenously. Continues for a maximum of six cycles.

Cisplatindrug

Administered intravenously. Continues for a maximum of six cycles.