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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05584267

Enrollment

140

Registered

2022-10-18

Start date

2022-12-25

Completion date

2026-12-31

Last updated

2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief 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.

Interventions

RADIATIONradiotherapy

Different cohorts received different doses of radiotherapy

DRUGChemotherapy + immunotherapy

Chemotherapy + immunotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intracranial progression-free survival	up to 2 years from enrollment	assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
sPFS	up to 2 years from enrollment	assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI

Secondary

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

Countries

China

Contacts

Primary ContactYongchang C Zhang, MD

zhangyongchang@csu.edu.cn+8613873123436

Backup ContactNong C Yang, MD

yangnong0217@163.com+8613873123436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026