RecruitingPhase 2NCT07425795

Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer

A Prospective, Single Arm, Phase II Clinical Study of Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer

Sponsor

Chongqing University Cancer Hospital

Enrollment

36 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an immunotherapy drug called tislelizumab plus chemotherapy, followed by targeted radiation to the chest, for people newly diagnosed with extensive-stage small cell lung cancer (a fast-growing type of lung cancer that has spread beyond the chest). **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of extensive-stage small cell lung cancer and have not received prior systemic treatment for it - You have measurable areas of cancer - You are in good enough health to participate (ECOG score 0–1) - Your life expectancy is at least 3 months - Your blood counts and organ function meet required thresholds **You may NOT be eligible if...** - You have received prior chemotherapy or immunotherapy for your extensive-stage disease - You are not well enough to tolerate treatment - Your blood counts or organ function are below required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab Combined With Chemotherapy

Patients with newly diagnosed ES-SCLC receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation is conducted. Those who experience remission are sequentially treated with tislelizumab combined with consolidation chest radiotherapy (TRT). After the consolidation therapy is completed, tislelizumab maintenance therapy is received until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The maximum duration of treatment is 2 years.