Phase 2 Study of PD-L1 Inhibitor Plus Apatinib as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

This research investigates the use of a PD-L1 inhibitor combined with apatinib as a first-line maintenance treatment for patients with extensive-stage small cell lung cancer ES-SCLC. The study aims to evaluate the 6-month progression-free survival rate in patients who have already undergone 4 to 6 cycles of induction therapy and achieved a response or stable disease. This is a phase 2, prospective, single-arm clinical study enrolling 40 participants to assess treatment effects and safety. Participants who respond to induction therapy with PD-L1 inhibitor plus chemotherapy will enter a maintenance phase receiving a PD-L1 inhibitor plus 250 mg of apatinib daily by mouth. The specific PD-L1 inhibitor used in maintenance matches the one given during induction and may include drugs such as adebelimab, atezolizumab, or durvalumab administered every three weeks. Maintenance treatment continues until disease progression, unacceptable side effects, withdrawal, or up to two years. Throughout the study, efficacy will be assessed by imaging using RECIST 1.1 criteria every six weeks for the first 48 weeks, then every nine weeks thereafter until disease progression or study end. Safety and survival outcomes such as median progression-free survival, overall survival, and response rates will also be monitored. Participants will be followed for up to two years, with regular laboratory tests and clinical evaluations to track treatment effects and adverse events.

PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer