This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of etoposide and carboplatin (administered intravenously) in combination with anlotinib (administered orally) in treatment-naive advanced NSCLC.
Lung cancer can be divided into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), of which SCLC accounts for about 15%-20%.Because of the high degree of malignancy of SCLC, patients often lose the opportunity of surgical treatment due to metastasis at the time of admission. Traditional cytotoxic drugs can improve the prognosis of patients and life treatment, but the survival benefit is very limited. Vascular targeted therapy is an important treatment strategy for metastatic lung cancer.Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor that has significant inhibitory activity against angiogenesis related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor related kinases such as PDGFR /, C-Kit, Ret, etc. (e.g., Met, FGFR1/2/3). An exploratory phase II study explored the efficacy of third-line single-drug therapy for ED-SCLC and found significant improvement in prognosis. Based on the above status and research results, the purpose of this study was to explore the efficacy and safety of anlotinib hydrochloride combined with etoposide/carboplatin in first-line treatment of extensive small-cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
anlotinib 10 mg/day orally (from days 1 to 14 in a 21-day cycle)
100mg/m2 iv on days 1-3 every 21 days for 4 cycles
AUC 5 iv on day 1 every 21 days for 4 cycles
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPFS
Time from enrollment to progression or death
Time frame: Time from randomization to progression, assessed 9-11 months
ORR
Patients who were assessed as partial response or complete response
Time frame: 6-9 weeks
OS
Time from enrollment to death of any cause
Time frame: 13-15 months
DCR
Patients who were assessed as partial response, complete response or stable disease
Time frame: 6-9 weeks
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