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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
2010
NCT00981058Uploaded 10-16-2018
Available for Download
PDS UID: LungNo_EliLill_2010_272
N/A
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 SummaryN/A
ConditionsN/A
Intervention TypeChemotherapy
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
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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