Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy
NCT00693992 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2019-06-11
Summary
This 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.
Conditions
- Stage IIIB Lung Non-Small Cell Cancer AJCC v7
- Stage IV Non-Small Cell Lung Cancer AJCC v7
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Placebo
Given PO
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- DRUG
-
Sunitinib Malate
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Mark A Socinski · Alliance for Clinical Trials in Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-15
- Primary Completion
- 2013-11-08
- Completion
- 2015-05-28
Countries
- United States
Study Locations
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