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)

Anhui Cancer Hospital

Hefei, Anhui, China

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NCT06838208


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