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

NCT07035860 | Not Yet Recruiting DMC

• 1 other identifier: HZCIRT-Lung 001
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carbon Ion Radiotheray

Keywords

non-small cell lung cancer; carbon ion radiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (2)

• 1-year PFS

  Time between enrollment and recurrence of disease or death

  12 months

• Incidence of Grade ≥3 Treatment-Related Adverse Events

  Safety

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

Secondary Outcomes (1)

• OS

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

Other Outcomes (1)

• Biomarker Analysis

  36 months

Study Arms (1)

Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy

Radiation: Carbon ion radiotherapy; Drug: Chemotherapy; Drug: Immunotherapy

Interventions

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.

Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy

Chemotherapy DRUG

platinum-based doublet chemotherapy

Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy

Immunotherapy DRUG

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

Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ji Yongling: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue, blood, urine, and stool samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Heavy Ion Radiotherapy; Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Yongling JI, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongling JI, MD

CONTACT

0086-571-88122088; drjyl@msn.com

Min Fang

CONTACT

0086-571-88122088; 541387924@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)