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.
PRIMARY OBJECTIVES: I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy. SECONDARY OBJECTIVES: I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting. II. To evaluate the additional response rate as a result of sunitinib in this setting. III. To assess the impact of sunitinib on overall survival compared to the placebo arm. IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13). V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
210
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Providence Hospital
Mobile, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veteran's Administration Medical Center
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Progression Free Survival (PFS)
Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
Time frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)
Overall Survival (OS)
Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Time frame: Time from randomization to death (up to 5 years)
Response Rate (RR)
The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
Time frame: Duration of treatment (up to 5 years)
Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale
The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Time frame: At 3 months
Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale
The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Time frame: At 3 months
Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.
Time frame: Duration of study (up to 5 years)
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PCR Oncology
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