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

ConditionCarbon Ion Radiotheray
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorJi Yongling

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Patients with unresectable locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy3 interventions

Trial outcomes

Primary outcomes

1

1-year PFS

Time between enrollment and recurrence of disease or death

Time frame
12 months
2

Incidence of Grade ≥3 Treatment-Related Adverse Events

Safety

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

Secondary outcomes

1

OS

Time between enrollment and death

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

Other outcomes

1

Biomarker Analysis

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

Time frame
36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ji Yongling

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: