Actively Recruiting
Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
Led by Chongqing University Cancer Hospital · Updated on 2026-02-23
36
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.
CONDITIONS
Official Title
Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18-75 years
- Able to comply with the study protocol as judged by the investigator
- Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) per Veterans Administration lung cancer association staging
- No prior systemic treatment for ES-SCLC
- Measurable lesions according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1
- Life expectancy of at least 3 months
- Adequate blood counts and organ function within 14 days before first treatment: absolute neutrophil count ≥ 1.5 × 10^9/L without growth factor, lymphocyte count ≥ 0.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L, liver enzymes (AST, ALT, ALP) ≤ 2.5 × upper limit of normal (ULN) with exceptions for liver/bone metastases, total bilirubin ≤ 1.5 × ULN with exceptions for Gilbert syndrome, creatinine clearance ≥ 60 ml/min, albumin ≥ 25 g/L
You will not qualify if you...
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- History of leptomeningeal disease
- Poorly controlled pleural, pericardial effusion or ascites requiring frequent drainage
- Poorly controlled or symptomatic hypercalcemia
- Active or history of autoimmune disease or immunodeficiency
- History of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced or idiopathic pneumonia
- Active pulmonary tuberculosis
- Untreated chronic hepatitis B with high viral load or active hepatitis C infection
- Recent brain radiotherapy or neurosurgery within specified time frames before study treatment
- Requirement for corticosteroids for CNS disease; stable anticonvulsant use allowed
- Metastasis limited to specific brain regions without progression after local therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chongqing University Affiliated Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
Research Team
W
Wei Zhou, Professor
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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