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

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT06429696
Phase
PHASE2
Status
Recruiting
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Conditions

  • Small Cell Lung Cancer Extensive Stage

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PD-L1 inhibitor combined with apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 14, 2024
Status verified
May 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PD-L1 inhibitor combined with apatinib
    Six-month progression-free survival rate (6-month PFS rate) of PD-L1 inhibitor combined with apatinib in first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC)

Primary Outcome Measure

6-month progression-free survival (PFS) [ Time Frame: 2 years ]

Central Contacts

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