Sintilimab Combined With Anlotinib in Third Line or Beyond Among Advanced SCLC Patients
Small cell lung cancer (SCLC) accounts for 10-15% of lung cancer. More than 70% of SCLC patients are diagnosed with advanced stage initially. SCLC is highly chemo-sensitive, the first-line treatment is platinum-containing double-drug chemotherapy. Although the objective response rate (ORR) of first-line chemotherapy is as high as 60-80%, the duration of response is very short, and there is little effective follow-up treatment. The outcome of SCLC patients is poor with an overall survival (OS) of about 10 months. In August 2018, the FDA approved Nivolumab as a third-line treatment for advanced SCLC patients, which is the only immunotherapeutic drug approved for SCLC till now. Sintilimab is another PD-1 inhibitor produced by China and has been approved by cFDA for lymphoma. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) with effect of anti-tumor angiogenesis and tumor growth inhibition. The results of ALTER1202 show that compared with placebo, Anlotinib single-agent as three-line treatment in advanced SCLC was effective, the median progression free survival (PFS) were 4.1 versus 0.7 months, respectively (P < 0.0001). Immunotherapy combined with anti-angiogenic therapy has been proven effective and tolerable in non-small cell lung caner (NSCLC), while its efficacy and safety in SCLC has not been reported. Therefore, the investigators conduct this study to evaluate the efficacy and safety of Sintilimab combined with Anlotinib versus Anlotinib alone in third line or beyond among advanced SCLC patients.
Start: September 2019
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