NCT05758116

Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients

A Prospective, Open-label, Single-arm, Phase II Trial Investigating the Efficacy and Safety of Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.

Conditions

• Non-small Cell Lung Cancer
• Consolidation Immunotherapy
• Radiotherapy or Sequential Chemoradiation

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab: 200mg d1,q21d\*17

Timeline

• Start date: 2022-07-07
• Primary completion: 2025-07-07
• Completion: 2026-07-07
• First posted: 2023-03-07
• Last updated: 2024-11-26

Locations

1 site across 1 country: China