Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy

Non Small Cell Lung Cancer Clinical Trial

Official title:

Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584267
• Other study ID #: RENO
• Status: Recruiting
• Phase: Phase 2
• Start date: December 25, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang C Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years of age on day of signing informed consent

• Histopathology confirmed non-small cell lung cancer

• Asymptomatic brain metastases

• EGFR/ALK ROS1 driver gene mutation negative

• RECIST 1.1 based available assessment of lesions

• ECOG 0-1

• Brain metastases 1-4

• Single lesion =4cm

Exclusion Criteria:

• Patients with contraindication of chemotherapy Pregnant or breast feeding women

Related Conditions & MeSH terms

• Brain Neoplasms
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Radiation:
• radiotherapy
Different cohorts received different doses of radiotherapy

Drug:
• Chemotherapy + immunotherapy
Chemotherapy + immunotherapy

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial progression-free survival	assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI	up to 2 years from enrollment
Primary	sPFS	assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI	up to 2 years from enrollment
Secondary	Objective Response rate	assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI	up to 2 years from enrollment
Secondary	overall survival	the time from enrollment until death or the last follow-up	up to 2 years from enrollment
Secondary	number of participants with treatment-related adverse events	number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 2 years from enrollment