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

This is a prospective, single-arm clinical study designed to evaluate the 6-month progression-free survival rate (6-month PFS rate) of a PD-L1 inhibitor combined with apatinib as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The study plans to recruit 40 patients. After receiving 4-6 cycles of induction therapy, patients whose efficacy is evaluated as CR, PR or SD (according to RECIST 1.1) will enter maintenance therapy with PD-L1 inhibitor + apatinib 250 mg po qd. , the selection of PD-L1 inhibitors in the maintenance phase is consistent with the first-line standard treatment in the induction phase. Efficacy was assessed using RECISIT 1.1, with imaging evaluations every 6 weeks (±7 days) for 48 weeks after the first dose and every 9 weeks (±7 days) after week 48, regardless of treatment delays or interruptions, until Disease progression or study termination, whichever occurs first. The primary efficacy endpoint of this study is 6-month PFS rate, and secondary efficacy endpoints include median PFS, median OS and safety.

NCT Number	NCT06429696
Lead Sponsor	Nanfang Hospital, Southern Medical University
Conditions	Small Cell Lung Cancer Extensive Stage
Enrollment	40 participants
Start Date	2024-07-14
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-28