NCT07035860

Efficacy and Safety of Chemoimmunotherapy and Carbon Ion Radiotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer

Efficacy and Safety of Induction Chemoimmunotherapy Followed by Carbon Ion Radiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 34 (estimated)
• Sponsor: Ji Yongling · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.

Detailed description

All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system would receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.

Conditions

• Carbon Ion Radiotheray

Interventions

Type	Name	Description
RADIATION	Carbon ion radiotherapy	Patients will receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
DRUG	Chemotherapy	platinum-based doublet chemotherapy
DRUG	Immunotherapy	The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.

Timeline

• Start date: 2025-06-16
• Primary completion: 2027-06-15
• Completion: 2028-06-15
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: China