This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
All eligible patients will receive Endostar in combination with Gemcitabine plus Platinum-based chemotherapy for 4 cycles (21 days for each cycle). Endostar treatment will continue after completion of chemotherapy cycles until disease progression. Efficacy will be evaluated every two cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
7.5mg/m2/day, iv, from day 1 to day 14
Gemcitabine 1000 mg/m2, iv, on day 1, 8 Cisplatin 80mg/m2, iv, on day 1, 2, 3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGProgression Free Survival (PFS)
Time frame: July 2011
Objective Response Rate (ORR)
Time frame: July 2011
Clinical Benefit Response (CBR)
Time frame: July 2011
Overall Survival (OS)
Time frame: July 2011
Survival Rate
Time frame: one year
Adverse Events
Time frame: July 2011
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