Efficacy and Safety of Chemoimmunotherapy and Carbon Ion Radiotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbon ion radiotherapy, Chemotherapy, Immunotherapy.
- Who it may be relevant to
- Registry conditions: Carbon Ion Radiotheray. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Induction Chemoimmunotherapy Followed by Carbon Ion Radiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer
Overview
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.
Interventions
- 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.
Primary outcome measures
- 1-year PFS [Time frame: 12 months]
- Incidence of Grade ≥3 Treatment-Related Adverse Events [Time frame: Occurrence or end of follow-up（3 years after enrollment), which comes first]
Secondary outcome measures (1)
- OS [Time frame: Occurrence or end of follow-up（3 years after enrollment）, which comes first]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07035860 · HZCIRT-Lung 001