Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen
Cancer - Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
sunitinib, chemotherapy, non-small cell lung cancer, NSCLC
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Sunitinib, chemotherapy
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Status: Recruiting
Start Date
March 2013
Completion Date
December 2014
Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Record processing date processed this data on July 28, 2015 page