Actively Recruiting
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
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 induction therapy with PD-L1 monoclonal antibody plus chemotherapy showing complete response, partial response, or stable disease
- At least 6 months treatment-free interval if previously treated with surgery, radiotherapy, or chemotherapy
- Expected survival of 12 weeks or more
- ECOG performance status of 0 or 1
- Laboratory values meeting specific blood counts, liver, kidney, and coagulation function requirements before first dose
- Negative pregnancy test for women of childbearing age within 7 days before first dose
- Agreement to use contraception during and up to 24 weeks after treatment
- Willingness to provide informed consent and comply with study procedures
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 metastasis; some stable brain metastases allowed under strict conditions
- Recurrent symptomatic fluid buildup requiring drainage (pericardial, pleural, or peritoneal effusion)
- History of serious lung diseases or infections affecting lung function
- Active autoimmune disease treated with immunosuppressants recently
- Serious cardiovascular disease or recent heart attack or stroke
- Other cancers within 5 years except certain treated localized cancers
- Uncontrolled high blood pressure
- Significant protein in urine
- Recent significant bleeding or bleeding disorders
- Recent intestinal obstruction or inability to swallow tablets
- Active infections including hepatitis B, hepatitis C, or HIV
- Major surgery within 28 days before screening or planned during study
- Recent systemic immunosuppressive therapy
- Recent live attenuated vaccine use or planned use during study
- Known allergy to study drugs or monoclonal antibodies
- Participation in other clinical trials recently
- History of bone marrow or solid organ transplant
- Other conditions or factors that may affect safety or study compliance as judged by the investigator
AI-Screening
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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
CONTACT
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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