Actively Recruiting
Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy
Led by Tang-Du Hospital · Updated on 2025-12-30
32
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 32 patients. The study commenced in August 2025, and recruitment is expected to conclude around December 2026, with the trial anticipated to end by December 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
CONDITIONS
Official Title
Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and good compliance for follow-up
- Age between 18 and 75 years old
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per AJCC 8th edition or VALG phase II criteria
- ECOG performance status score of 0 to 2
- No disease progression after 4-6 cycles of platinum-based chemotherapy combined with Adebrelimab induction therapy
- Recovery of non-hematologic adverse reactions to grade 1 (except alopecia, skin pigment changes, or as determined by investigator) after induction therapy
- Time from end of induction treatment to maintenance treatment initiation is 6 weeks or less
- At least one measurable lesion according to RECIST 1.1
- Normal major organ function including bone marrow, renal, liver, and coagulation meeting specified laboratory criteria
- Women of childbearing potential must use contraception during the study and for 6 months after, with negative pregnancy test within 1 week before enrollment; men must also use contraception during the study and for 6 months after
You will not qualify if you...
- Limited-stage small cell lung cancer (SCLC)
- Mixed histology SCLC
- Prior treatment with anti-angiogenic agents
- Conditions affecting oral drug intake such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks before enrollment
- Participation in another investigational drug trial within 4 weeks before enrollment
- Untreated or symptomatic brain metastases or spinal cord compression
- Concurrent active malignancy requiring treatment
- Active autoimmune disease or immunodeficiency, or history of such conditions except certain stable diseases
- History of psychiatric or substance abuse disorders interfering with compliance
- Severe or uncontrolled comorbid conditions including uncontrolled hypertension, significant heart disease, decompensated diabetes, severe respiratory disorders, severe infections, uncontrolled effusions, liver cirrhosis or active hepatitis, renal insufficiency
- Severe infection within 4 weeks before first dose
- Grade III-IV immune-related adverse events during induction with PD-L1 inhibitors
- Active brain or leptomeningeal metastases at enrollment except stable treated cases
- Investigator judgment of inability or unlikely compliance with study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China, 710000
Actively Recruiting
Research Team
L
Lei Pan, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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