Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen

Study Overview
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Brief Summary
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The purpose of this study is to determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.

Official Title
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Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen

Conditions
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Cancer, Lung Cancer

Intervention / Treatment
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* Drug: Sunitinib, chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic diagnosis of stage IIIB/IV NSCLC ECOG PS: 0,1 Unidimensional or bi-dimensional measurable disease Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor Evidence of disease progression Life expectancy >12 weeks Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL Exclusion Criteria: Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry Uncontrolled hypertension CHF, angina or arrhythmias LVEF < 1 UNL Existing a second malignancy within 5 years Infected with HIV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib<br> | Drug: Sunitinib, chemotherapy<br>* sunitinib, 12.5mg/day, for 7 days before each cycle of chemotherapy; chemotherapy, single agent including docetaxel, albumin-bound paclitaxel, vinorelbine, gemcitabine, pemetrexed, or paclitaxel, as determined by the investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | To evaluate the median over-all survival of this regimen | up to 2 years | 
| disease control rate | To evaluate the disease-control rate of this regimen. | up to 6 months | 
| Safety | To evaluate the safety of this regimen including the rate and grade of adverse effects. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sunitinib, chemotherapy, non-small cell lung cancer, NSCLC