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Starting soon Observational

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

NCT07035860 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-06-16
Last updated
2025-06-25

Condition(s) studied

Carbon Ion Radiotheray

Investigational drug(s) / intervention(s)

Carbon ion radiotherapyChemotherapyImmunotherapy

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.

Chemotherapy: platinum-based doublet chemotherapy

Immunotherapy: The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 1-year PFS — 12 months
    Time between enrollment and recurrence of disease or death
  • Incidence of Grade ≥3 Treatment-Related Adverse Events — Occurrence or end of follow-up(3 years after enrollment), which comes first
    Safety

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035860 on ClinicalTrials.gov ↗ ← All trials in China