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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
July 2010
NCT00457392Uploaded 01-16-2015
Available for Download
PDS UID: LungNo_Pfizer_2007_115
A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib
Provider Information
Provider Data DescriptionThe primary end point was OS. Key secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.
SponsorPfizer
Data ProviderPfizer
Partial set or SubsetOriginal Data
Patients in dataset960
# of Patients Control480
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/s3gm-eb30
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.
ConditionsCarcinoma, Non-Small Cell Lung
Intervention TypeDrug: erlotinib
Drug: sunitinib
Drug: erlotinib
Drug: placebo
Drug(s)Drug: erlotinib
Drug: sunitinib
Drug: placebo
Total Enrolled960
RandomizationRandomized
Blinding MethodTriple
Arms Intervention1 - Experimental
2 - Active Comparator
Secondary IDSUN1087
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Argentina
Austria
Belgium
Brazil
Canada
Chile
Colombia
Czech Republic
Denmark
Germany
Greece
Hong Kong
Hungary
Italy
Korea, Republic of
Netherlands
Norway
Poland
Russian Federation
Slovakia
Spain
Switzerland
Taiwan
Thailand
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLA6181087 Final Protocol 14 MAR 2007.pdf
CRFSample-case-report-form_A6181087_Final_Version11_11-APR-2011.pdf
DATA DICTIONARYA6181087_SPECS.xlsx
DATA (COMPARATOR ARM)adverse.sas7bdat
DATA (COMPARATOR ARM)cd_b_p.sas7bdat
DATA (COMPARATOR ARM)cn_6_p.sas7bdat
DATA (COMPARATOR ARM)cn_7_p.sas7bdat
DATA (COMPARATOR ARM)cn_8_p.sas7bdat
DATA (COMPARATOR ARM)condrug.sas7bdat
DATA (COMPARATOR ARM)contrt.sas7bdat
DATA (COMPARATOR ARM)demog.sas7bdat
DATA (COMPARATOR ARM)ecg.sas7bdat
DATA (COMPARATOR ARM)final.sas7bdat
DATA (COMPARATOR ARM)iota_p.sas7bdat
DATA (COMPARATOR ARM)lab_safe.sas7bdat
DATA (COMPARATOR ARM)pfm_p.sas7bdat
DATA (COMPARATOR ARM)phyexam.sas7bdat
DATA (COMPARATOR ARM)prevdis.sas7bdat
DATA (COMPARATOR ARM)primdiag.sas7bdat
DATA (COMPARATOR ARM)random.sas7bdat
DATA (COMPARATOR ARM)testdrug.sas7bdat
DATA (COMPARATOR ARM)tmm_p.sas7bdat
DATA (COMPARATOR ARM)vitals.sas7bdat
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