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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-16

Study Completion Date

2028-06-15

Brief Summary

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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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Detailed Description

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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

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Carbon Ion Radiotheray

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy

Carbon ion radiotherapy

Intervention Type 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

Intervention Type DRUG

platinum-based doublet chemotherapy

Immunotherapy

Intervention Type DRUG

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

Interventions

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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.

Intervention Type RADIATION

Chemotherapy

platinum-based doublet chemotherapy

Intervention Type DRUG

Immunotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No