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

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

Inclusion Criteria:

1. Age≥18 years old, male or female, signed Informed Consent Form (ICF);
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
3. Histologically or cytologically confirmed ES-SCLC;
4. No prior systemic treatment for ES-SCLC;
5. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
6. Adequate hematologic and end organ function;

Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
2. 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;
3. Was administered a live vaccine ≤ 4 weeks before treatment;
4. Active autoimmune diseases or history of autoimmune diseases that may relapse;
5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
7. 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;
8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;