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

Phase 2

• Conditions: Cancer; Lung Cancer
• Interventions: Drug: Sunitinib, chemotherapy

• Registration Number: NCT01850147
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-18
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-07
• Last Update Submitted: 2013-05-07
• Study First Posted: 2013-05-09
• Last Update Posted: 2013-05-09
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunitinib	Sunitinib, chemotherapy	-

Primary Outcome Measures

Name	Time	Method
progression-free survival	up to 2 years	The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China