NCT07425795

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Interventions

Type	Name	Description
DRUG	Tislelizumab 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.

Timeline

• Start date: 2025-10-10
• Primary completion: 2027-12-31
• Completion: 2028-07-31
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: China