Actively Recruiting
Single-arm, Prospective Clinical Study of PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-05-28
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
PD-L1 Inhibitor Combined With Apatinib as First-line Maintenance Treatment for Extensive-stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Confirmed extensive-stage small cell lung cancer by histology or cytology
- Completed first-line treatment with PD-L1 inhibitor plus chemotherapy showing complete response, partial response, or stable disease
- Previous surgical treatment and curative adjuvant therapy allowed if treatment-free interval is at least 6 months before diagnosis of extensive-stage SCLC
- Expected survival time of at least 12 weeks
- ECOG performance status score of 0 or 1
- Laboratory tests meeting specified blood, liver, kidney, and coagulation function limits before first study drug dose
- Negative pregnancy test for women of childbearing age and agreement to use contraception during and up to 24 weeks after treatment
- Voluntary participation with informed consent and good compliance
You will not qualify if you...
- Small cell lung cancer transformed from non-small cell carcinoma or mixed histology
- Meningeal or symptomatic central nervous system metastases; asymptomatic brain metastases allowed with restrictions
- Recurrent symptomatic third space effusions requiring repeated drainage
- History of serious lung diseases or infections affecting lung function
- Active autoimmune disease or recent use of corticosteroids or immunosuppressants above specified doses
- Serious cardiovascular diseases including recent heart failure, unstable angina, arrhythmia, or myocardial infarction
- Other malignant tumors within past 5 years except certain treated cancers
- Uncontrolled hypertension
- Significant proteinuria
- Recent significant bleeding or bleeding disorders, or use of anticoagulants/antiplatelets
- Recent intestinal obstruction or gastrointestinal perforation; inability to swallow tablets
- Active infections including hepatitis B, hepatitis C, or HIV
- Major surgery within 28 days prior to screening or planned during study
- Recent systemic immunosuppressive treatment
- Recent live attenuated vaccines
- Allergies to study drugs or monoclonal antibodies
- Participation in another clinical trial or experimental drug treatment within 4 weeks
- History of bone marrow or solid organ transplantation
- Other factors judged by investigator affecting safety or study compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive PD-L1 inhibitor combined with apatinib as first-line maintenance treatment. After 4-6 cycles of induction therapy, those with stable disease or better enter maintenance therapy until disease progression, intolerable side effects, withdrawal, or up to 2 years.
Treatment cycles every 3 weeks
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
W
Wangjun Liao, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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