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Completed Phase 3 Interventional Results available

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin

ClinicalTrials.gov ID: NCT00981058

Public ClinicalTrials.gov record NCT00981058. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 12:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00981058
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
1,093 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 7, 2010 (Actual)
Primary completion
Jun 17, 2013 (Actual)
Completion
May 30, 2024 (Actual)
Last update posted
Jun 18, 2025

2010 – 2024

United States locations

U.S. sites
15
U.S. states
15
U.S. cities
15
Facility City State ZIP Site status
ImClone Investigational Site Chandler Arizona 85224 —
ImClone Investigational Site Fayetteville Arkansas 72703 —
ImClone Investigational Site Sacramento California 95816 —
ImClone Investigational Site Galesburg Illinois 61401 —
ImClone Investigational Site Goshen Indiana 46526 —
ImClone Investigational Site Wichita Kansas 67214 —
ImClone Investigational Site Hazard Kentucky 41701 —
ImClone Investigational Site Baltimore Maryland 21204 —
ImClone Investigational Site Jefferson City Missouri 65109 —
ImClone Investigational Site Lincoln Nebraska 68510 —
ImClone Investigational Site New York New York 10065 —
ImClone Investigational Site Akron Ohio 44304 —
ImClone Investigational Site Camp Hill Pennsylvania 17011 —
ImClone Investigational Site Memphis Tennessee 38104 —
ImClone Investigational Site Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 167 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00981058, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 18, 2025 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00981058 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →