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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
2013-06-17
NCT00981058Uploaded 10-16-2018
Available for Download
PDS UID: LungNo_EliLill_2010_272
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)
Provider Information
Provider Data DescriptionPrimary Objective: The primary objective of this study was to evaluate the overall survival (OS) in patients with Stage IV squamous NSCLC (per the American Joint Committee on Cancer [AJCC] Staging Manual, Seventh Edition [AJCC7]) treated with necitumumab plus gemcitabine and cisplatin chemotherapy (GC+N Arm) versus gemcitabine and cisplatin chemotherapy alone (GC Arm) in the first-line metastatic setting. Key Secondary Objectives: To evaluate progression-free survival (PFS) in each arm; to evaluate the objective response rate (ORR) in each arm; to evaluate the time to treatment failure (TTF) in each arm; to evaluate the safety profile of necitumumab in combination with gemcitabine and cisplatin chemotherapy;
SponsorEli Lilly
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset1093
# of Patients Control548
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/05tc-jx78
CDISC StandardADAM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsNon Small Cell Lung Cancer
Intervention TypeBiological: Necitumumab
Drug: Gemcitabine
Drug: Cisplatin
Drug(s)Drug: Gemcitabine
Drug: Cisplatin
Total Enrolled1093
RandomizationRandomized
Blinding MethodNone
Arms InterventionNecitumumab + Gemcitabine + Cisplatin - Experimental
Gemcitabine + Cisplatin - Active Comparator
Secondary IDCP11-0806
PubMed (PMID)29158123
27207107
26980471
26045340
Collaborator(s)Parexel
PPD
Medidata Solutions
Laboratory Corporation of America
University of Colorado, Denver
Thermo Fisher Scientific FS
ICON Clinical Research
Pacific Biomarkers
Sysmex Inostics GmbH
Intertek
Region(s)United States
Australia
Austria
Belgium
Brazil
Canada
Croatia
France
Germany
Greece
Hungary
Italy
Korea, Republic of
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Singapore
Slovakia
South Africa
Spain
Taiwan
Thailand
United Kingdom
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files:
PROTOCOLV6-0 Protocol CP11-0806-redact_v3.pdf
CRFjfcc_acrf_redacted.pdf
DATA DICTIONARYjfcc_adam_define_redacted.pdf
DATA (COMPARATOR ARM)jfcc_deid_ctrl_trt.zip
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