RecruitingPhase 2NCT06838208
Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC
Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study
Sponsor
Anhui Provincial Cancer Hospital
Enrollment
56 participants
Start Date
Feb 25, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- Age≥18 years old, male or female, signed Informed Consent Form (ICF);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Histologically or cytologically confirmed ES-SCLC;
- No prior systemic treatment for ES-SCLC;
- At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
- Adequate hematologic and end organ function;
Exclusion Criteria8
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
- Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
- Was administered a live vaccine ≤ 4 weeks before treatment;
- Active autoimmune diseases or history of autoimmune diseases that may relapse;
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
- With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;
- Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;
Interventions
DRUGTislelizumab, Carboplatin /Cisplatin, Etoposide
Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f;
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06838208
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