Small Cell Lung Carcinoma Clinical Trial
Official title:
A Randomized, Open-label Study of Lobaplatin/Etoposide as First Line Therapy With or Without Anlotinib Maintenance Therapy in Patients With Extensive-stage Small-cell Lung Cancer
This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of
malignancy, short doubling time, early and widespread metastasis, is sensitive to
chemotherapy and radiotherapy, and has a high initial response rate, but is prone to
secondary drug resistance and relapse. The treatment is mainly based on systemic
chemotherapy.
SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined
with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy.
Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has
been reported that Anlotinib has the dual benefits of both overall survival and
progression-free survival in the treatment of multiple tumors, and has initially demonstrated
its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both
the overall and progression-free survival of NSCLC patients. However, there is no clinical
study to probe its relevance to small cell lung cancer, and few studies have examined the
status of Anlotinib in first-line treatment.
This randomized, open-label, controlled study is to evaluate the efficacy and safety of
sequential EL regimen with Anlotinib hydrochloride as first-line treatment for
extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence
for the use of Anlotinib for SCLC first-line treatment.
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