NCT06536868

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Hospital of Shanxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).
DRUG	Etoposide	Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).
DRUG	Carboplatin 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).
RADIATION	Thoracic radiotherapy	IMRT 30-45Gy/10-15f

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2024-08-05
• Last updated: 2024-08-05

Locations

6 sites across 1 country: China