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RECRUITING
NCT06429696
PHASE2

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

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: Single-arm, Prospective Clinical Study of PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-07-14

Completion Date

2026-04-30

Last Updated

2025-05-28

Healthy Volunteers

No

Interventions

DRUG

PD-L1 inhibitor combined with apatinib

Every 3 weeks (21 days) is a treatment cycle. After 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 until the disease progresses and becomes intolerable. Toxic and side effects, death, withdrawal of information or the investigator's decision to withdraw the subject from the study, non-compliance with study treatment or other reasons specified in the study procedures or protocol, or treatment for up to 2 years. Maintenance treatment: PD-L1 inhibitor + apatinib 250 mg po qd, maintained for up to 2 years. Note: The specific PD-L1 inhibitor is selected by the researcher, such as adebelimab 1200mg iv, q3w; or atezolizumab 1200mg iv d1, q3w; or durvalumab 1500mg iv d1, q3w . The selection of PD-L1 inhibitors in the maintenance phase is consistent with the first-line standard treatment in the induction phase.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China