Actively Recruiting
Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of Extensive Small Cell Lung Cancer
Led by Anhui Provincial Cancer Hospital · Updated on 2025-09-24
56
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining Tislelizumab with chemotherapy and relayed radiotherapy as a first treatment for people with extensive-stage small cell lung cancer (ES-SCLC). This phase II clinical study aims to explore this combination to potentially improve outcomes in this aggressive lung cancer type. The treatment plan includes Tislelizumab given intravenously at 200 mg every three weeks along with chemotherapy drugs etoposide and either cisplatin or carboplatin for four cycles. After this induction phase, participants continue receiving Tislelizumab every three weeks as maintenance treatment for up to two years or until the disease worsens, unacceptable side effects occur, or consent is withdrawn. Radiotherapy is also given, with low-dose radiotherapy targeting lung lesions initially and stereotactic body radiotherapy focusing on main residual lesions during maintenance. Participants will be monitored regularly to assess progression-free survival, the main outcome measured from the start until disease progression or death for up to about 23 months. Other assessments include response rates, duration of response, disease control, overall survival, and tracking of treatment-related side effects. The study involves comprehensive evaluations including imaging and clinical assessments to understand how participants respond to the combined treatment over time.
CONDITIONS
Brief Title
Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female, with signed informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed extensive-stage small cell lung cancer
- No prior systemic treatment for extensive-stage small cell lung cancer
- At least one measurable chest lesion suitable for 15Gy/5f radiotherapy
- Adequate blood counts and organ function
You will not qualify if you...
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Prior therapy with immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Received a live vaccine within 4 weeks before treatment
- Active or history of autoimmune diseases that may relapse
- Need for systemic corticosteroids or immunosuppressive medication within 14 days before treatment
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases
- Severe chronic or active infections requiring systemic therapy within 2 weeks before treatment
- Use of therapeutic oral or intravenous antibiotics within 2 weeks before starting treatment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years or until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent
Participants receive Tislelizumab combined with chemotherapy (etoposide and carboplatin or cisplatin) for 4 cycles. This is followed by maintenance therapy with Tislelizumab and relayed radiotherapy to lung lesions and residual disease.
Drug infusions every 3 weeks and radiotherapy sessions totaling 10 fractions
Trial Site Locations
Total: 1 location
1
Anhui Cancer Hospital
Hefei, Anhui, China, 230031
Actively Recruiting
Research Team
S
Shuanghu Yuan, 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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