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

Ji Yongling

Status: Not yet enrolling

Conditions: Carbon Ion Radiotheray

Treatments: Drug: Chemotherapy; Drug: Immunotherapy; Radiation: Carbon ion radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT07035860

HZCIRT-Lung 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unresectable, locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).
• No prior anti-cancer treatment.
• No significant internal medical conditions or major organ dysfunction.

Exclusion criteria

• Histological evidence of small cell lung cancer or other primary malignancies
• EGFR, ALK, or ROS-1 gene mutations.
• Active or prior autoimmune/inflammatory disorders.
• Inability to comply with study protocol as judged by the investigator.

Trial design

34 participants in 1 patient group

Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy

Treatment:

Radiation: Carbon ion radiotherapy

Drug: Immunotherapy

Drug: Chemotherapy