RecruitingPhase 2NCT06536868

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial


Sponsor

Second Hospital of Shanxi Medical University

Enrollment

40 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests combining an immunotherapy drug (tislelizumab) with chemotherapy and chest radiation for extensive-stage small cell lung cancer — a fast-growing lung cancer that has spread at the time of diagnosis. The goal is to improve survival beyond standard chemotherapy alone. **You may be eligible if...** - You are aged 18–80 with confirmed extensive-stage small cell lung cancer - You have not yet received treatment for this stage of the disease - You have at least one measurable tumor on imaging - You are in good physical condition and expected to survive at least 3 months **You may NOT be eligible if...** - You have previously received chemotherapy or radiation for extensive-stage SCLC - Your vital organ functions (liver, kidneys, heart) are significantly compromised - You have serious autoimmune disease or recent major infection 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

Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).

DRUGEtoposide

Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).

DRUGCarboplatin or Cisplatin

Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).

RADIATIONThoracic radiotherapy

IMRT 30-45Gy/10-15f


Locations(6)

Jincheng General Hospital

Jincheng, Shanxi, China

Jinzhong third people's hospital

Jinzhong, Shanxi, China

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Shanxi Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, China

TISCO General Hospital

Taiyuan, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT06536868


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