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

N/ANot Yet RecruitingNCT07035860

Ji Yongling34 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Carbon Ion Radiotheray

Interventions

Carbon ion radiotherapyRADIATION

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.

ChemotherapyDRUG

platinum-based doublet chemotherapy

ImmunotherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

1-year PFS

Time between enrollment and recurrence of disease or death

Time frame: 12 months

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

Time between enrollment and death

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

Central Contacts

Yongling JI, MD

CONTACT

0086-571-88122088 drjyl@msn.com

Min Fang

CONTACT

0086-571-88122088 541387924@qq.com

Data from ClinicalTrials.gov

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