NCT06849167

Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in LA-NSCLC

A Single-Arm Phase II Clinical Trial of Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with locally advanced NSCLC (Non-Small Cell Lung Cancer) who have a PD-L1 TPS ≥ 20% will be included in this study. It aims to explore the efficacy and safety of immunotherapy combined with hypofractionated concurrent chemoradiotherapy, followed by consolidation immunotherapy. Participants will undergo large fractionated radiotherapy with a total dose of 48Gy/16 fractions, 3Gy per fraction, 5 days a week. Participants will receive two cycles of concurrent platinum-based doublet chemotherapy and concurrent immunotherapy. Patients without progression will receive consolidation immunotherapy. The maximum duration of immunotherapy is 24 months.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	hypofractionated radiotherapy with immunotherapy	Immunotherapy combined with hypofractionated concurrent chemoradiotherapy followed by consolidation immunotherapy

Timeline

• Start date: 2025-03-01
• Primary completion: 2029-03-01
• Completion: 2030-03-01
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: China