Actively Recruiting
Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study
Led by Sun Yat-sen University · Updated on 2026-05-13
90
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the efficacy and safety between teniposide, cisplatin and serplulimab regimen and etoposide, cisplatin and serplulimab regimen in the treatment of extensive stage small lung cancer
CONDITIONS
Official Title
Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with extensive stage small cell lung cancer
- No previous systemic treatment for extensive stage small cell lung cancer
- Patients intolerant to synchronous radiotherapy and chemotherapy or with specific prior treatment histories
- Measurable lesions with clear progression beyond previously irradiated lesions when applicable
- ECOG performance status of 0 or 1
- Expected survival time longer than 3 months
- Adequate blood counts and organ function (Hb 100g/L; ANC 1.510^9/L; PLT 10010^9/L; WBC 3.010^9/L; liver and kidney function within specified limits)
- Women of childbearing age must have a negative pregnancy test within 28 days prior to enrollment and agree to contraception during and 6 months after the study; men must also agree to contraception
- Ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Unstable or symptomatic brain metastases requiring treatment
- Active autoimmune diseases needing systemic treatment within 2 years prior to enrollment
- Immunodeficiency or recent use of systemic immunosuppressive therapies
- Other untreated malignant tumors within the past 5 years
- Conditions affecting oral medication intake such as swallowing difficulties or gastrointestinal issues
- Uncontrollable pleural, pericardial effusions, or ascites needing repeated drainage
- Untreated or unstable spinal cord compression
- Significant hemoptysis within 2 weeks before enrollment
- Adverse events from previous treatments not resolved to mild level
- Recent major surgery or trauma within 28 days
- Recent serious thrombotic events within 6 months
- History of psychiatric drug abuse or mental disorders affecting participation
- Poor blood pressure control or significant heart conditions
- Active or uncontrolled infections, liver diseases, HIV positive status, or significant proteinuria
- Recent treatments with blood transfusions or growth factors within 14 days prior to study
- Any other serious diseases that could endanger safety or study completion as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
SUN-YAT-SEN University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
Wenfeng Fang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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