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NCT Number: NCT07035860

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

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.

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Key information

Conditions

Carbon Ion Radiotheray Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbon Ion Radiotherapy

Radiation

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

Drug

platinum-based doublet chemotherapy

Immunotherapy

Drug

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

Primary outcomes

  1. 1-year PFS

    Time frame: 12 months

    Time between enrollment and recurrence of disease or death

  2. Incidence of Grade ≥3 Treatment-Related Adverse Events

    Time frame: Occurrence or end of follow-up（3 years after enrollment), which comes first

    Safety

Secondary outcomes

  1. OS

    Time frame: Occurrence or end of follow-up（3 years after enrollment）, which comes first

    Time between enrollment and death

Other outcomes

  1. Biomarker Analysis

    Time frame: 36 months

    Including ctDNA levels and their correlation with treatment response; additional biomarkers include PD-L1 expression, TMB, RNA expression profiles, immune cell subtypes, cytokines, metabolites, tumor and gut microbiota

Study contacts

Contact information is provided by the study sponsor or research team.

Min Fang

CONTACT

[email protected]

0086-571-88122088

Yongling JI, MD

CONTACT

[email protected]

0086-571-88122088

Sponsors and collaborators

Lead sponsor

Ji Yongling

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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