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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
2013-11-08
NCT00693992Uploaded 12-15-2018
Access via NCI by Request
PDS UID: nci-data-379
Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer
Provider Information
Provider Data DescriptionDataset NCT00693992-D3-Dataset.csv (qol) is one of 3 datasets associated with PubMed ID 28161554. This dataset contains information that will allow you to reproduce the quality of life (qol) analysis. Due to data cleaning efforts, values may contain slight discrepancies from that reported in Table 1 of the Supplemental Materials.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.
ConditionsStage IIIB Lung Non-Small Cell Cancer AJCC v7
Stage IV Non-Small Cell Lung Cancer AJCC v7
Intervention TypeOther: Laboratory Biomarker Analysis
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sunitinib Malate
Drug(s)Drug: Sunitinib Malate
Total Enrolled210
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I (sunitinib malate) - Experimental
Arm II (placebo) - Placebo Comparator
Secondary IDNCI-2009-00469
PubMed (PMID)28161554
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00693992-D3
Data DictionaryNCT00693992-D3-Data-Dictionary.pdf
DATANCT00693992-D3-Dataset.csv
OTHERREADME.pdf
Files: NCT00693992-D2
Data DictionaryNCT00693992-D2-Data-Dictionary.pdf
DATANCT00693992-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00693992-D1
Data DictionaryNCT00693992-D1-Data-Dictionary.pdf
DATANCT00693992-D1-Dataset.csv
OTHERREADME.pdf
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