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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Lung Cancer; Cancer

Treatments: Drug: Sunitinib, chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01850147

SU-2013-041

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Sunitinib

Experimental group

Treatment:

Drug: Sunitinib, chemotherapy