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Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC

Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC

Recruiting
18 years and older
All
Phase 2

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Overview

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

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;

Study details
    Extensive-stage Small Cell Lung Cancer (ES-SCLC)

NCT06838208

Anhui Provincial Cancer Hospital

15 October 2025

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