RecruitingPhase 2NCT06429696

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

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

40 participants

Start Date

Jul 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a PD-L1 immunotherapy drug with apatinib (a drug that blocks blood vessel growth in tumors) as maintenance treatment — after initial chemotherapy plus immunotherapy — can keep extensive-stage small cell lung cancer (SCLC) from coming back for longer. **You may be eligible if...** - You are between 18 and 75 years old - You have extensive-stage small cell lung cancer confirmed by biopsy or cytology - You completed first-line treatment with a PD-L1 immunotherapy drug plus chemotherapy, and your cancer responded or stayed stable - You are in generally good health **You may NOT be eligible if...** - Your SCLC developed from a non-small cell lung cancer (NSCLC) - Your cancer has a mixed cell type - You have cancer that has spread to the lining of the brain (meninges) - You have symptomatic brain metastases (asymptomatic or treated and stable brain metastases may be acceptable) - You have poorly controlled heart disease, active autoimmune disease, or serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPD-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06429696


Related Trials