First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
NCT00981058 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1093
Last updated 2025-06-18
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.
Conditions
- Non Small Cell Lung Cancer
Interventions
- BIOLOGICAL
-
Necitumumab
Administered intravenously. Continues until progressive disease, toxicity, noncompliance, or withdrawal.
- DRUG
-
Administered intravenously. Continues for a maximum of six cycles.
- DRUG
-
Administered intravenously. Continues for a maximum of six cycles.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY -
PPD Development, LP
collaborator INDUSTRY -
Medidata Solutions
collaborator INDUSTRY -
Laboratory Corporation of America
collaborator INDUSTRY -
University of Colorado, Denver
collaborator OTHER -
Thermo Fisher Scientific FS
collaborator OTHER -
ICON Clinical Research
collaborator INDUSTRY -
Pacific Biomarkers
collaborator OTHER -
Sysmex Inostics GmbH
collaborator INDUSTRY -
Intertek
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-01-07
- Primary Completion
- 2013-06-17
- Completion
- 2024-05-30
Countries
- United States
- Australia
- 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
Study Locations
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