Spots Global Cancer Trial Database for Tislelizumab in Combination With Anlotinib With ES-SCLC as Maintenance Therapy After First Line Chemotherapy

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Trial Identification

Brief Title: Tislelizumab in Combination With Anlotinib With ES-SCLC as Maintenance Therapy After First Line Chemotherapy

Official Title: A Prospective, Open Label, Single-arm, Phase 2 Study of Tislelizumab in Combination With Anlotinib as Maintenance Therapy in Subject With Extensive Stage Small Cell Lung Cancer （ES-SCLC） as Maintenance Therapy After First Line Chemotherapy

Study ID: NCT04620837

Conditions

Small Cell Lung Carcinoma

Interventions

Tislelizumab

Anlotinib hydrochloride

Study Description

Brief Summary: To show that maintenance therapy with Tislelizumab plus Anlotinib will prolong Progression Free Survival in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.

Detailed Description: Most patients with extensive disease small cell lung cancer (ED-SCLC) respond to first line（1L） platinum-based chemotherapy; however, responses are not durable and prognosis is poor. Currently no maintenance treatments are approved in SCLC to prolong the durability of efficacy achieved with 1L chemotherapy. Immuno-oncology agents have demonstrated efficacy in the treatment of ED-SCLC when administered across different lines of therapy. Tislelizumab (Anti-PD-1 antibody) Combine Etoposide+ platinum （EP） had improved median Overall survival （mOS ） to 15.6m of 1L ED-SCLC in the Rationale 206 study. Anlotinib ( RTKi ) had significantly improved PFS \& OS of 3L(third line) ED-SCLC in the ALTER 1202. This phase II study is designed to explore the effect and safety of the combination as maintenance therapy for ED-SCLC after 1L chemotherapy